Health and Human Services Secretary Sylvia M. Burwell announced today the release of a new study, published in the New England Journal of Medicine, estimating that 10.3 million uninsured adults gained health care coverage following the first open enrollment period in the Health Insurance Marketplace. The report examines trends in insurance before and after the open enrollment period and finds greater gains among those states that expanded their Medicaid programs under the Affordable Care Act.

“We are committed to providing every American with access to quality, affordable health services and this study reaffirms that the Affordable Care Act has set us on a path toward achieving that goal,” said Secretary Burwell. “This study also reaffirms that expanding Medicaid under the Affordable Care Act is important for coverage, as well as a good deal for states. To date, 26 states plus D.C. have moved forward with Medicaid expansion. We’re hopeful remaining states will come on board and we look forward to working closely with them.”

According to the authors’ findings, the uninsured rate for adults ages 18 to 64 fell from 21 percent in September 2013 to 16.3 percent in April 2014. After taking into account economic factors and pre-existing trends, this corresponded to a 5.2 percentage-point change, or 10.3 million adults gaining coverage. The decline in the uninsured was significant for all age, race/ethnicity, and gender groups, with the largest changes occurring among Latinos, blacks, and adults ages 18-34 – groups the Administration targeted for outreach during open enrollment.

Coverage gains were concentrated among low-income adults in states expanding Medicaid and among individuals in the income range eligible for Marketplace subsidies. The study finds a 5.1 percentage point reduction in the uninsured rate associated with Medicaid expansion, while in states that have not expanded their Medicaid programs, the change in the uninsured rate among low-income adult populations was not statistically significant.

Today’s study also looks at access to care, and finds that within the first six months of gaining coverage, more adults (approximately 4.4 million) reported having a personal doctor and fewer (approximately 5.3 million) experienced difficulties paying for medical care.

Today’s study does not include data from before 2012, as coverage was changing rapidly during this period. This means the results do not include the more than 3 million young adults who gained health insurance coverage through their parents’ plans.

The analysis builds on previous studies by reviewing a larger sample size and taking into account changes in the economy and pre-existing trends in insurance coverage. Using survey data from the Gallup-Healthways Well-Being Index for January 1, 2012, through June 30, 2014, the authors analyzed changes in the uninsured rate over time. This is also the first study to associate reductions in the uninsured rate with state-level statistics on enrollment in the Marketplaces and Medicaid under the Affordable Care Act, as described in HHS enrollment reports, and to assess the impact of the improved coverage on access to care.

www.hhs.gov

oday marks the end of the 10th outbreak of Ebola virus disease in the Democratic Republic of the Congo (DRC). This long, complex and difficult outbreak has been overcome due to the leadership and commitment of the Government of the DRC, supported by the World Health Organization (WHO), a multitude of partners, donors, and above all, the efforts of the communities affected by the virus.

WHO congratulates all those involved in the arduous and often dangerous work required to end the outbreak, but stresses the need for vigilance. Continuing to support survivors and maintaining strong surveillance and response systems in order to contain potential flare-ups is critical in the months to come.

“The outbreak took so much from all of us, especially from the people of DRC, but we came out of it with valuable lessons, and valuable tools. The world is now better-equipped to respond to Ebola. A vaccine has been licensed, and effective treatments identified,” said WHO Director-General Dr Tedros Adhanom Ghebreyesus.

“We should celebrate this moment, but we must resist complacency. Viruses do not take breaks. Ultimately, the best defence against any outbreak is investing in a stronger health system as the foundation for universal health coverage.”

The outbreak, declared in North Kivu on 1 August 2018, was the second largest in the world, and was particularly challenging as it took place an active conflict zone. There were 3470 cases, 2287 deaths and 1171 survivors.

Led by the DRC Government and the Ministry of Health and supported by WHO and partners, the more than 22-month-long response involved training thousands of health workers, registering 250 000 contacts, testing 220 000 samples, providing patients with equitable access to advanced therapeutics, vaccinating over 303 000 people with the highly effective rVSV-ZEBOV-GP vaccine, and offering care for all survivors after their recovery.

The response was bolstered by the engagement and leadership of the affected communities. Thanks to their efforts, this outbreak did not spread globally. More than 16 000 local frontline responders worked alongside the more than 1500 people deployed by WHO. Support from donors was essential, as was the work of UN partner agencies, national and international NGOs, research networks, and partners deployed through the Global Outbreak Alert and Response Network. Hard work to build up preparedness capacities in neighbouring countries also limited the risk of the outbreak expanding.

Work will continue to build on the gains made in this response to address other health challenges, including measles and COVID-19.

“During the almost two years we fought the Ebola virus, WHO and partners helped strengthen the capacity of local health authorities to manage outbreaks,” said Dr Matshidiso Moeti, WHO Regional Director for Africa.

“The DRC is now better, smarter and faster at responding to Ebola and this is an enduring legacy which is supporting the response to COVID-19 and other outbreaks.”

As countries around the world face the COVID-19 pandemic, the DRC Ebola response provides valuable lessons. Many of the public health measures that have been successful in stopping Ebola are the same measures that are now essential for stopping COVID-19: finding, isolating, testing, and caring for every case and relentless contact tracing.

In DRC, community workers were provided with training and a smartphone data collection app that enabled them to track contacts and report in real time rather than fill in laborious paper reports. Even when violence locked down cities, the community workers, many of them local women, continued to track and trace contacts using the application, something that was crucial for ending this outbreak.

While this 10th outbreak in DRC has ended, the fight against Ebola continues. On 1 June 2020, seven cases of Ebola were reported in Mbandaka city and neighbouring Bikoro Health Zone in Equateur Province and an 11th outbreak was declared. WHO is supporting the government-led response with more than 50 staff already deployed and more than 5000 vaccinations already administered.

WHO salutes the thousands of heroic responders who fought one of the world’s most dangerous viruses in one of the world’s most unstable regions. Some health workers, including WHO experts, paid the ultimate price and sacrificed their lives to the Ebola response.

Geneva/Oslo, 24 August 2020 – 172 economies are now engaged in discussions to potentially participate in COVAX, a global initiative aimed at working with vaccine manufacturers to provide countries worldwide equitable access to safe and effective vaccines, once they are licensed and approved. COVAX currently has the world’s largest and most diverse COVID-19 vaccine portfolio – including nine candidate vaccines, with a further nine under evaluation and conversations underway with other major producers.

COVAX, the vaccines pillar of the Access to COVID-19 Tools (ACT) Accelerator, is co-led by the Coalition for Epidemic Preparedness Innovations (CEPI), Gavi, the Vaccine Alliance, and the World Health Organization (WHO) – working in partnership with developed and developing country vaccine manufacturers. It is the only global initiative that is working with governments and manufacturers to ensure COVID-19 vaccines are available worldwide to both higher-income and lower-income countries.

In order to be able to secure enough doses of vaccines to protect the most vulnerable populations, such as health workers and the elderly, the next step for the partnership is to confirm potential self-financing participants’ intent to participate by 31 August and to turn these into binding commitments to join the COVID-19 Vaccine Global Access Facility (COVAX Facility) by September 18th, with first upfront payments to follow thereafter, and no later than October 9th.

“Equal access to a COVID-19 vaccine is the key to beating the virus and paving the way for recovery from the pandemic,” said Stefan Löfven, Prime Minister of Sweden. “This cannot be a race with a few winners, and the COVAX Facility is an important part of the solution – making sure all countries can benefit from access to the world’s largest portfolio of candidates and fair and equitable distribution of vaccine doses.”

The COVAX Facility is a Gavi-coordinated pooled procurement mechanism for new COVID-19 vaccines, through which COVAX will ensure fair and equitable access to vaccines for each participating economy, using an allocation framework currently being formulated by WHO. The COVAX Facility will do this by pooling buying power from participating economies and providing volume guarantees across a range of promising vaccine candidates, allowing those vaccine manufacturers whose expertise is essential to large scale production of the new vaccines, to make early, at-risk investments in manufacturing capacity – providing participating countries and economies with the best chance at rapid access to doses of a successful COVID-19 vaccine.

The success of COVAX hinges not only on countries signing up to the COVAX Facility, but also filling key funding gaps for both COVAX R&D work and a mechanism to support participation of lower-income economies in the COVAX Facility.

“COVID-19 is an unprecedented global health challenge that can only be met with unprecedented cooperation between governments, researchers, manufacturers and multilateral partners,” said Dr Tedros Adhanom Ghebreyesus, Director-General of WHO. “By pooling resources and acting in solidarity through the ACT Accelerator and the COVAX Facility, we can ensure that once a vaccine is available for COVID-19, it’s available equitably to all countries.”

CEPI is leading COVAX vaccine research and development work, which aims to develop three safe and effective vaccines which can be made available to countries participating in the COVAX Facility. Nine candidate vaccines are currently being supported by CEPI; seven of which are currently in clinical trials. Governments, vaccine manufacturers (in addition to their own R&D), organizations and individuals have committed $1.4bn towards vaccine R&D so far, but an additional $1bn is urgently needed to continue to move the portfolio forward.

A further nine candidates vaccines which complement the current CEPI portfolio are currently being evaluated for inclusion in COVAX. Furthermore, COVAX will consider procuring vaccines that complement the portfolio from any producer in the world; conversations are already underway with a number of additional manufacturers not receiving R&D support from CEPI to procure their vaccines if they are successful. Maximizing the portfolio of vaccines increases the probability of success as individual vaccines historically have a high failure rate.

“In the scramble for a vaccine, countries can act alone – creating a few winners, and many losers – or they can come together to participate in COVAX, an initiative which is built on enlightened self-interest but also equity, leaving no country behind,” said Richard Hatchett, CEO of CEPI. “Only by taking a global view can we protect those most at risk around the world from the terrible effects of this disease. COVAX can deliver the vaccines that could end the pandemic, but it needs countries to step forward both to join the COVAX Facility, and also to address the serious funding shortfalls, including for R&D. The decisions that are taken now about COVID-19 vaccines have the power to change our future. We must be courageous and ambitious in striving for a multilateral solution.”

A collaboration between Serum Institute of India (SII), Gavi and the Bill & Melinda Gates Foundation announced earlier this month will ensure up to 100 million doses of AstraZeneca or Novavax’s candidate vaccines, if successful, will be available to low- and middle-income economies through the COVAX Facility at just US$ 3 per dose. The arrangement also provides an option to secure additional doses if COVAX sees a need for it. Separate agreements between Gavi, CEPI and AstraZeneca, announced in June, guarantee a further 300 million doses of their candidate vaccine, if successful, for the COVAX Facility.

In addition, in June Gavi launched the COVAX Advance Market Commitment (AMC), a financing instrument aimed at supporting the participation of 92 lower and middle income economies in the COVAX Facility. The COVAX AMC has raised more than US$ 600 million against an initial target of securing US$ 2 billion seed funding from sovereign donors as well as philanthropy and the private sector, needed by the end of 2020. Funding the COVAX AMC will be critical to ensuring ability to pay is not a barrier to accessing COVID-19 vaccines, a situation which would leave the majority of the world unprotected, with the pandemic and its impact continuing unabated.

80 higher-income economies, which would finance the vaccines from their own public finance budgets, have so far submitted Expressions of Interest ahead of the August 31 deadline for confirmation of intent to participate. They will partner with 92 low- and middle-income countries that will be supported by the AMC if it meets its funding targets. Together, this group of 172 countries represents more than 70% of the world’s population. Among the group are representatives from every continent and more than half of the world’s G20 economies.

“The momentum we are witnessing behind this unprecedented global effort means there could be light at the end of the tunnel: A vaccine is our best route to ending the acute phase of the pandemic and the COVAX effort is the best way to get there,” said Dr Seth Berkley, CEO of Gavi, the Vaccine Alliance. “For higher-income countries it represents a win-win: not only will you be guaranteed access to the world’s largest portfolio of vaccines, you will also be negotiating as part of a global consortium, bringing down prices and ensuring truly global access. Signing up to the COVAX Facility gives each country its best chance at protecting the most vulnerable members of their populations – which in turn gives the world its best chance at mitigating the toll this pandemic has taken on individuals, communities and the global economy. To make this end-to-end vision a reality, we need countries to make end-to-end commitments: funding R&D, signing up to the Facility, and supporting the COVAX AMC.”

The COVAX Facility is coordinated by Gavi, the Vaccine Alliance, and forms a key part of COVAX – the vaccines pillar of the ACT Accelerator, a ground-breaking global collaboration involving vaccine manufacturers to accelerate the development, production, and equitable access to COVID-19 tests, treatments, and vaccines. The overall aim of COVAX is to accelerate the development and manufacture of COVID-19 vaccines, and to guarantee fair and equitable access for every country in the world. It will achieve this by sharing the risks associated with vaccine development, and where necessary investing in manufacturing upfront so vaccines can be deployed at scale as soon as they are proven to be safe and effective, and pooling procurement and purchasing power to achieve sufficient volumes to end the acute phase of the pandemic by 2021.

The goal of COVAX is by the end of 2021 to deliver two billion doses of safe, effective vaccines that have passed regulatory approval and/or WHO prequalification. These vaccines will be offered equally to all participating countries, proportional to their populations, initially prioritising healthcare workers then expanding to cover vulnerable groups, such as the elderly and those with pre-existing conditions. Further doses will then be made available based on country need, vulnerability and COVID-19 threat. The COVAX Facility will also maintain a buffer of doses for emergency and humanitarian use, including dealing with severe outbreaks before they spiral out of control.

The full list of CEPI-supported candidate vaccines is as follows:

· Inovio, USA (Phase I/II)

· Moderna, USA (Phase III)

· CureVac, Germany (Phase I)

· Institut Pasteur/Merck/Themis, France/USA/Austria (Preclinical)

· AstraZeneca/University of Oxford, UK (Phase III)

· University of Hong Kong, China (Preclinical)

· Novavax, USA (Phase I/II)

· Clover Biopharmaceuticals, China (Phase I)

· University of Queensland/CSL, Australia (Phase I)

The nine candidate vaccines that are currently being evaluated for inclusion in the Facility include two from the US, two from China, two from the USA, one from South Korea, one from the UK and one global, multi-manufacture partnership. Two of these are in Phase I trials, two are tech transfers and the remainder are at the discovery stage.

The 80 countries that have submitted expressions of interest to the Gavi-coordinated COVAX Facility include 43 that have agreed to be publicly named: Andorra, Argentina, Armenia, Botswana, Brazil, Canada, Chile, Colombia, Croatia, Czech Republic, Dominican Republic, Estonia, Finland, Greece, Iceland, Iraq, Ireland, Israel, Japan, Jordan, Kuwait, Lebanon, Luxembourg, Mauritius, Mexico, Monaco, Montenegro, New Zealand, North Macedonia, Norway, Palau, Portugal, Qatar, Republic of Korea, San Marino, Saudi Arabia, Seychelles, Singapore, South Africa, Switzerland, United Arab Emirates, United Kingdom of Great Britain & Northern Ireland, Venezuela.

In July the Gavi Board agreed on the 92 economies that will be supported the COVAX Advance Market Commitment (AMC). The full list is as follows:

· Low income: Afghanistan, Benin, Burkina Faso, Burundi, Central African Republic, Chad, Congo, Dem. Rep., Eritrea, Ethiopia, Gambia, The Guinea, Guinea-Bissau, Haiti, Korea, Dem. People’s Rep., Liberia, Madagascar, Malawi, Mali, Mozambique, Nepal, Niger, Rwanda, Sierra Leone, Somalia, South Sudan, Syrian Arab Republic, Tajikistan, Tanzania, Togo, Uganda, Yemen, Rep.,

· Lower-middle income: Angola, Algeria, Bangladesh, Bhutan, Bolivia, Cabo Verde, Cambodia, Cameroon, Comoros, Congo, Rep. Côte d’Ivoire, Djibouti, Egypt, Arab Rep., El Salvador, Eswatini, Ghana, Honduras, India, Indonesia, Kenya, Kiribati, Kyrgyz Republic Lao PDR, Lesotho, Mauritania, Micronesia, Fed. Sts., Moldova, Mongolia, Morocco, Myanmar, Nicaragua, Nigeria, Pakistan, Papua New Guinea, Philippines, São Tomé and Principe, Senegal, Solomon Islands, Sri Lanka, Sudan, Timor-Leste, Tunisia, Ukraine, Uzbekistan, Vanuatu, Vietnam, West Bank and Gaza, Zambia, Zimbabwe

· Additional IDA eligible: Dominica, Fiji, Grenada, Guyana, Kosovo, Maldives, Marshall Islands, Samoa, St. Lucia, St. Vincent and the Grenadines, Tonga, Tuvalu.

About Gavi, the Vaccine Alliance
Gavi, the Vaccine Alliance is a public-private partnership that helps vaccinate half the world’s children against some of the world’s deadliest diseases. Since its inception in 2000, Gavi has helped to immunise a whole generation – over 760 million children – and prevented more than 13 million deaths, helping to halve child mortality in 73 developing countries. Gavi also plays a key role in improving global health security by supporting health systems as well as funding global stockpiles for Ebola, cholera, meningitis and yellow fever vaccines. After two decades of progress, Gavi is now focused on protecting the next generation and reaching the unvaccinated children still being left behind, employing innovative finance and the latest technology – from drones to biometrics – to save millions more lives, prevent outbreaks before they can spread and help countries on the road to self-sufficiency. Learn more at www.gavi.org and connect with us on Facebook and Twitter.

The Vaccine Alliance brings together developing country and donor governments, the World Health Organization, UNICEF, the World Bank, the vaccine industry, technical agencies, civil society, the Bill & Melinda Gates Foundation and other private sector partners. View the full list of donor governments and other leading organizations that fund Gavi’s work here.

About CEPI
CEPI is an innovative partnership between public, private, philanthropic, and civil organisations, launched at Davos in 2017, to develop vaccines to stop future epidemics. CEPI has moved with great urgency and in coordination with WHO in response to the emergence of COVID-19. CEPI has initiated nine partnerships to develop vaccines against the novel coronavirus. The programmes are leveraging rapid response platforms already supported by CEPI as well as new partnerships.

Before the emergence of COVID-19, CEPI’s priority diseases included Ebola virus, Lassa virus, Middle East Respiratory Syndrome coronavirus, Nipah virus, Rift Valley Fever and Chikungunya virus. CEPI also invested in platform technologies that can be used for rapid vaccine and immunoprophylactic development against unknown pathogens (Disease X).

About WHO
The World Health Organization provides global leadership in public health within the United Nations system. Founded in 1948, WHO works with 194 Member States, across six regions and from more than 150 offices, to promote health, keep the world safe and serve the vulnerable. Our goal for 2019-2023 is to ensure that a billion more people have universal health coverage, to protect a billion more people from health emergencies, and provide a further billion people with better health and wellbeing.

Abbott Laboratories has agreed to pay the United States $5.475 million to resolve allegations that it violated the False Claims Act by paying kickbacks to induce doctors to implant the company’s carotid, biliary and peripheral vascular products, the Justice Department announced today. Abbott is a global pharmaceuticals and health care products company based in Abbott Park, Ill.

“Patients have a right to treatment decisions that are based on their own medical needs, not the personal financial interests of their health care providers,” said Assistant Attorney General Stuart F. Delery of the Civil Division of the Department of Justice. “Kickbacks undermine the ability of health care providers to objectively evaluate and treat their patients, and will continue to be a primary focus of the Department’s health care enforcement efforts.”

The settlement resolves allegations that Abbott knowingly paid prominent physicians for teaching assignments, speaking engagements and conferences with the expectation that these physicians would arrange for the hospitals with which they were affiliated to purchase Abbott’s carotid, biliary and peripheral vascular products. As a result, the United States alleged Abbott violated the Anti-Kickback Act and caused the submission of false claims to Medicare for the procedures in which these Abbott products were used.

“Physicians should make decisions regarding medical devices based on what is in the best interest of patients without being induced by payments from manufacturers competing for their business,” said U.S. Attorney Bill Killian of the Eastern District of Tennessee.

“Offering financial inducements can distort health care decision-making,” said Special Agent in Charge Derrick L. Jackson of the U.S. Department of Health and Human Services, Office of Inspector General in Atlanta. “OIG and our law enforcement partners vigilantly protect government health programs from such alleged abuses.”

Carotid and peripheral vascular products are used to treat circulatory disorders by increasing blood flow to the head and various parts of the body, respectively. Biliary products are used to treat obstructions that occur in the bile ducts.

The settlement resolves allegations originally brought in a lawsuit filed by Steven Peters and Douglas Gray, former Abbott employees, under the qui tam provision of the False Claims Act , which allows whistleblowers to file suit on behalf of the United States for false claims and share in any recovery As part of today’s resolution, Peters and Gray will receive a total payment of more than $1 million.

This settlement illustrates the government’s emphasis on combating health care fraud and marks another achievement for the Health Care Fraud Prevention and Enforcement Action Team (HEAT) initiative, which was announced in May 2009 by Attorney General Eric Holder and Health and Human Services Secretary Kathleen Sebelius. The partnership between the two departments has focused efforts to reduce and prevent Medicare and Medicaid financial fraud through enhanced cooperation. One of the most powerful tools in this effort is the False Claims Act. Since January 2009, the Justice Department has recovered a total of more than $17 billion through False Claims Act cases, with more than $12.2 billion of that amount recovered in cases involving fraud against federal health care programs.

This settlement was the result of an investigation by the Justice Department’s Civil Division, the U.S. Attorney’s Offices for the Eastern District of Tennessee and the Northern District of California and the Office of Inspector General at the U.S. Department of Health and Human Services.

This Press Release is courtesy the USDOJ

NORTH CHICAGO, Ill. and SUNNYVALE, Calif., — AbbVie (NYSE:ABBV) and Pharmacyclics (NASDAQ: PCYC) today announced a definitive agreement under which AbbVie will acquire Pharmacyclics, and its flagship asset Imbruvica® (ibrutinib), a highly effective treatment for hematologic malignancies. The acquisition accelerates AbbVie’s clinical and commercial presence in oncology, strengthening its already robust pipeline, and establishing its strong leadership position in hematological oncology – an attractive and rapidly growing market, now approaching $24 billion globally. The acquisition adds to AbbVie’s already comprehensive pipeline and strong growth prospects.

Under the terms of the transaction, AbbVie will pay $261.25 per share comprised of a mix of cash and AbbVie equity. The transaction values Pharmacyclics at approximately $21 billion and was approved by the Boards of Directors of both companies.

Imbruvica® is a Bruton’s tyrosine kinase (BTK) inhibitor approved for use in four indications to treat three different types of blood cancers including chronic lymphocytic leukemia, mantle cell lymphoma and Waldenstrom’s macroglobulinemia. Imbruvica® received initial U.S. Food and Drug Administration (FDA) approval in 2013 and is the only therapy to have received three Breakthrough Therapy designations by the FDA. It is currently approved in more than 40 countries. Significant opportunity exists with further Imbruvica® indications, including solid tumors, the potential to leverage AbbVie’s immunology expertise for the development of Pharmacyclics’ immunology program, and advance AbbVie’s efforts in hematologic malignancies.

“The acquisition of Pharmacyclics is a strategically compelling opportunity. The addition of Pharmacyclics’ talented and innovative team will add enormous value to AbbVie,” said Richard A. Gonzalez, chairman and chief executive officer, AbbVie. “Its flagship product, Imbruvica®, is not only complementary to AbbVie’s oncology pipeline, it has demonstrated strong clinical efficacy across a broad range of hematologic malignancies and raised the standard of care for patients.”

“Team Pharmacyclics is honored and enthusiastic to join the AbbVie organization. We share a common purpose. Together and as one, our focus remains to create a remarkable difference for patient betterment around the world,” said Bob Duggan, chairman and chief executive officer, Pharmacyclics.

Transaction Terms
AbbVie will acquire all of the outstanding shares of common stock of Pharmacyclics through a tender offer, followed by a second-step merger. In the tender offer, AbbVie will offer to acquire all of the outstanding shares of Pharmacyclics’ common stock for $261.25 per share, consisting of cash and AbbVie common stock. Pharmacyclics’ stockholders will be permitted to elect cash, AbbVie common stock or a combination, subject to proration. The aggregate consideration will consist of approximately 58% cash and 42% AbbVie common stock. The closing of the tender offer is subject to customary closing conditions, including regulatory approvals, and the tender of a majority of outstanding shares of Pharmacyclics’ common stock, and is expected to close in mid-2015.

AbbVie will acquire all remaining shares of Pharmacyclics’ common stock that are not tendered in the tender offer through a second-step merger, which will be completed immediately following the tender offer and without a vote of Pharmacyclics’ stockholders.

AbbVie expects to fund the transaction through a combination of existing cash, new debt and stock.

Conference Call Details
AbbVie will host a conference call Thursday, March 5, 2015 at 8 am Central time to discuss this transaction. The call will be webcast through AbbVie’s Web site at www.abbvieinvestor.com.

Advisors
Morgan Stanley & Co. LLC acted as financial advisor, and Wachtell, Lipton, Rosen & Katz acted as legal counsel, to AbbVie. Centerview Partners LLC and J.P. Morgan Securities LLC acted as financial advisors, and Wilson Sonsini Goodrich & Rosati, P.C. acted as legal counsel, to Pharmacyclics.

About AbbVie
AbbVie is a global, research-based biopharmaceutical company formed in 2013 following separation from Abbott Laboratories. The company’s mission is to use its expertise, dedicated people and unique approach to innovation to develop and market advanced therapies that address some of the world’s most complex and serious diseases. AbbVie employs more than 26,000 people worldwide and markets medicines in more than 170 countries. For further information on the company and its people, portfolio and commitments, please visit www.abbvie.com. Follow @abbvie on Twitter or view careers on our Facebook or LinkedIn page.

About Pharmacyclics
Pharmacyclics, Inc. (NASDAQ: PCYC) is a biopharmaceutical company focused on developing and commercializing innovative small-molecule drugs for the treatment of cancer and immune mediated diseases. The company’s mission is to build a viable biopharmaceutical company that designs, develops and commercializes novel therapies intended to improve quality of life, increase duration of life and resolve serious unmet medical needs. It will do so by identifying and controlling promising product candidates based on scientific development and administrative expertise, developing its products in a rapid, cost-efficient manner and, pursuing commercialization and/or development partners when and where appropriate.

Pharmacyclics markets IMBRUVICA and has three product candidates in clinical development and several preclinical molecules in lead optimization. The company is committed to high standards of ethics, scientific rigor and operational efficiency as it moves each of these programs to commercialization. Pharmacyclics is headquartered in Sunnyvale, CA. To learn more, please visit www.pharmacyclics.com.

GENEVA – Urgent action is needed globally and locally to achieve safe and sustainably managed water, sanitation and hygiene for all in order to prevent devastating impacts on the health of millions of people.

Findings from WHO and UN-Water’s Global Analysis and Assessment of Sanitation and Drinking-Water (GLAAS) report show that acceleration is needed in many countries to achieve the UN Sustainable Development Goal (SDG) 6 – water and sanitation for all by 2030.

While 45% of countries are on track to achieve their nationally-defined drinking-water coverage targets, only 25% of countries are on track to achieve their national sanitation targets. Less than a third of countries reported to have sufficient human resources required to carry out key drinking-water, sanitation and hygiene (WASH) functions.

The GLAAS 2022 report, which details the latest status of WASH systems in more than 120 countries, is the largest data collection from the greatest number of countries to date.

While there has been an increase in WASH budgets in some countries, a large number–over 75% of countries reported insufficient funding to implement their WASH plans and strategies.

“We are facing an urgent crisis: poor access to safe drinking water, sanitation and hygiene claim millions of lives each year, while the increasing frequency and intensity of climate-related extreme weather events continue to hamper the delivery of safe WASH services,” said Dr Tedros Adhanom Ghebreyesus, WHO Director-General. “We call on governments and development partners to strengthen WASH systems and dramatically increase investment to extend access to safely managed drinking water and sanitation services to all by 2030, beginning with the most vulnerable.”

The GLAAS data show, however, that most WASH policies and plans do not address risks of climate change to WASH services, nor the climate resilience of WASH technologies and management systems. Just over two thirds of countries have measures in WASH policies to reach populations disproportionately affected by climate change. However, only about one third monitor progress or allocate explicit funding to these populations.

“The world is seriously off-track to achieve SDG 6 on water and sanitation for all, by 2030. This leaves billions of people dangerously exposed to infectious diseases, especially in the aftermath of disasters, including climate change-related events,” said Gilbert F. Houngbo, Chair of UN-Water, and Director General of the International Labour Organization. “The new data from GLAAS will inform the voluntary commitments the international community will make at the UN 2023 Water Conference in March, helping us target the most vulnerable communities and solve the global water and sanitation crisis.”

Urgency and opportunities
Dire consequences of climate change and extreme weather events bring more attention to the issues, underlining an urgent need for a whole-of-society approach and global cooperation to act together. The GLAAS 2022 report shows that countries making progress demonstrated high level of political commitment and investments in improving safe WASH systems.

With the GLAAS 2022 report, WHO and UN-Water call on all governments and stakeholders to scale up support for WASH service delivery, through strengthened governance, financing, monitoring, regulation, and capacity development.

The report sets the scene for action ahead of a historic water and sanitation meeting planned in 2023. For the first time in 50 years, the global community—through the United Nations—will review progress and make firm commitments to renew action on water and sanitation with global leaders. The UN 2023 Water Conference – formally known as the 2023 Conference for the Midterm Comprehensive Review of Implementation of the UN Decade for Action on Water and Sanitation (2018-2028) – will take place at UN Headquarters in New York, 22-24 March 2023.

The UN-Water Global Analysis and Assessment of Sanitation and Drinking-Water (GLAAS) data portal is now online at https://glaas.who.int

About the World Health Organization
Dedicated to the well-being of all people and guided by science, the World Health Organization leads and champions global efforts to give everyone, everywhere an equal chance at a safe and healthy life. Our mission is to promote health, keep the world safe and serve the vulnerable. More at www.who.int

About UN-Water

UN-Water coordinates the United Nations’ work on water and sanitation. UN-Water is a ‘coordination mechanism’. It is comprised of United Nations entities (Members) and international organizations (Partners) working on water and sanitation issues. UN-Water’s role is to ensure that Members and Partners’ deliver as one’ in response to water-related challenges.

Today, the Administration took several steps to help ensure women, whose coverage is threatened, receive coverage for recommended contraceptive services at no additional cost, as they should be entitled to under the Affordable Care Act. The rules, which are in response to recent court decisions, balance our commitment to helping ensure women have continued access to coverage for preventive services important to their health, with the Administration’s goal of respecting religious beliefs. The first administration action announced today maintains the existing accommodation for certain religious non-profits, but also creates an additional pathway for eligible organizations to provide notice of their objection to covering contraceptive services. In addition, the Administration is soliciting comment on how it might extend to certain closely held for-profit companies the same accommodation that is available to non-profit religious organizations, while continuing to urge Congress to take action to ensure women’s access to contraception services.

“Women across the country deserve access to recommended preventive services that are important to their health, no matter where they work,” said Health and Human Services Secretary Sylvia Burwell. “Today’s announcement reinforces our commitment to providing women with access to coverage for contraception, while respecting religious considerations raised by non-profit organizations and closely held for-profit companies.”

In July 2013, the Administration published final rules providing women with coverage for recommended preventive care, including all Food and Drug Administration-approved contraceptive services prescribed by a health care provider, without cost-sharing, while providing an accommodation for certain non-profit religious employers that object to contraceptive coverage on religious grounds so that they do not have to contract, arrange, pay, or refer for such coverage for their employees or students.

The rules announced today address both non-profits and closely held for-profit entities:

Interim Final Rule for Non-profits: a second pathway
The interim final regulations lay out an additional way for organizations eligible for an accommodation to provide notice of their religious objection to providing coverage for contraceptive services. The rule allows these eligible organizations to notify the Department of Health and Human Services in writing of their religious objection to providing contraception coverage. HHS and the Department of Labor will then notify insurers and third party administrators so that enrollees in plans of such organizations receive separate coverage for contraceptive services, with no additional cost to the enrollee or the employer. The interim final rule solicits comments, but goes into effect upon publication.

Closely Held For-Profit Entities
The Administration is also issuing a proposed rule soliciting comments on how it might extend to certain closely held for-profit entities, like Hobby Lobby, the same accommodation that is available to non-profit religious organizations. Under the proposal, these companies would not have to contract, arrange, pay or refer for contraceptive coverage to which they object on religious grounds. The proposal seeks comment on how to define a closely held for-profit company and whether other steps might be appropriate to implement this policy.

The administration continues to encourage Congress to act to ensure that women affected by the Supreme Court’s Hobby Lobby decision have access to the same coverage options offered to others, while it begins the process of soliciting feedback to determine how, through rulemaking, it can ensure that the religious concerns of organizations are respected and women are able to get coverage of recommended preventive services without cost sharing, as intended under the health care law.

The rules are available here: http://www.ofr.gov/inspection.aspx

Aetna and Humana Inc. announced on July 3 that they have entered into a definitive agreement under which Aetna will acquire all outstanding shares of Humana for a combination of cash and stock valued at $37 billion or approximately $230 per Humana share based on the closing price of Aetna common shares on July 2, 2015.

In a news release, the companies said, “The complementary combination brings together Humana’s growing Medicare Advantage business with Aetna’s diversified portfolio and commercial capabilities to create a company serving the most seniors in the Medicare Advantage program and the second-largest managed care company in the United States. The combined entity will help drive better value and higher-quality health care by reducing administrative costs, leveraging best-in-breed practices from the two companies — including Humana’s chronic-care capabilities that measurably improve health outcomes for larger populations — and enabling the company to better compete with more cost effective products.”

The joint release also noted that, “The combined company will be well positioned to offer a broad choice of affordable, consumer-centric health care products, helping to constrain cost growth, improve health outcomes, and promote wellness. The combination will provide Aetna with an enhanced ability to work with providers and create value-based payment agreements that result in better care to consumers, and spread cutting-edge clinical practices and quality care.”

After closing Aetna will make Louisville the headquarters for its Medicare, Medicaid and TRICARE businesses, and will maintain a significant corporate presence in Louisville. Founded in Louisville more than 50 years ago, Humana has a long history of contributing to the Louisville community.

Aetna Chairman and CEO Mark T. Bertolini said, “The acquisition of Humana aligns two great companies and will significantly advance our strategy of more effectively serving members in a rapidly changing health care industry.”

He noted the combination “will allow us to continue to invest in excellent service for our members and strengthen our partnerships with providers to deliver high quality care at an affordable price. We have great respect for Humana, their talented team, their culture and their strong medical management capabilities. We look forward to working with them following the closing, as we enhance our combined portfolio of innovative health care offerings to provide significant benefits to consumers, employers and providers, and to continue delivering value for our shareholders.”

Bruce D. Broussard, president and CEO of Humana, said, “Aetna and Humana share a strong commitment to improving the health and well-being of consumers, whatever their needs and wherever they are on their lifelong health journey. Through the use of technology and integrated services to simplify the consumer experience, the combined entity will be even more effective in meeting the health needs of many more people — especially people with chronic conditions, who will benefit from Humana’s home health, pharmacy management, and data analytics programs. The transaction is a testament to the accomplishments of Humana associates and an outstanding outcome for our shareholders, who will receive an immediate premium and the opportunity to participate in the growth potential of the combined organization.”

The combination of Aetna and Humana:
Builds on each company’s respective efforts to provide innovative, technology-driven products, services and solutions to build healthier populations, promote higher quality health care at lower cost, and offer greater transparency and convenience for consumers.
Increases Aetna’s Medicare Advantage membership to 4.4 million and improves Aetna’s ability to serve members and their providers with cutting-edge technology and best practices.
Brings together two companies with leading percentages of membership in Medicare plans rated four Stars or higher.
Creates a leading health care services and pharmacy benefit franchise, serving members who use over 600 million prescriptions annually.
Strengthens care management capabilities by taking the best-of-breed provider solutions, including robust offerings of patient-centered provider services, clinical intelligence, value-based reimbursement models, data integration and analytics solutions from both companies.
Brings together two companies with longstanding commitments to promoting wellness, health, and access to high-quality health care for everyone, while supporting the communities in which they serve.
Aetna-Humana-Project-Element-Button-300×300-A

Important Information For Investors And Stockholders

This communication does not constitute an offer to sell or the solicitation of an offer to buy any securities or a solicitation of any vote or approval. In connection with the proposed transaction between Aetna Inc. (“Aetna”) and Humana Inc. (“Humana”), Aetna and Humana will file relevant materials with the Securities and Exchange Commission (the “SEC”), including an Aetna registration statement on Form S-4 that will include a joint proxy statement of Aetna and Humana that also constitutes a prospectus of Aetna, and a definitive joint proxy statement/prospectus will be mailed to stockholders of Aetna and Humana. INVESTORS AND SECURITY HOLDERS OF AETNA AND HUMANA ARE URGED TO READ THE JOINT PROXY STATEMENT/PROSPECTUS AND OTHER DOCUMENTS THAT WILL BE FILED WITH THE SEC CAREFULLY AND IN THEIR ENTIRETY WHEN THEY BECOME AVAILABLE BECAUSE THEY WILL CONTAIN IMPORTANT INFORMATION. Investors and security holders will be able to obtain free copies of the registration statement and the joint proxy statement/prospectus (when available) and other documents filed with the SEC by Aetna or Humana through the website maintained by the SEC at http://www.sec.gov. Copies of the documents filed with the SEC by Aetna will be available free of charge on Aetna’s internet website at http://www.Aetna.com or by contacting Aetna’s Investor Relations Department at 860-273-8204. Copies of the documents filed with the SEC by Humana will be available free of charge on Humana’s internet website at http://www.Humana.com or by contacting Humana’s Investor Relations Department at 502-580-3644.

Aetna, Humana, their respective directors and certain of their respective executive officers may be considered participants in the solicitation of proxies in connection with the proposed transaction. Information about the directors and executive officers of Humana is set forth in its Annual Report on Form 10-K for the year ended December 31, 2014, which was filed with the SEC on February 18, 2015, its proxy statement for its 2015 annual meeting of stockholders, which was filed with the SEC on March 6, 2015, and its Current Report on Form 8-K, which was filed with the SEC on April 17, 2015. Information about the directors and executive officers of Aetna is set forth in its Annual Report on Form 10-K for the year ended December 31, 2014 (“Aetna’s Annual Report”), which was filed with the SEC on February 27, 2015, its proxy statement for its 2015 annual meeting of shareholders, which was filed with the SEC on April 3, 2015 and its Current Reports on Form 8-K, which were filed with the SEC on May 19, 2015 and May 26, 2015. Other information regarding the participants in the proxy solicitations and a description of their direct and indirect interests, by security holdings or otherwise, will be contained in the joint proxy statement/prospectus and other relevant materials to be filed with the SEC when they become available.

Brazzaville – The independent Africa Regional Certification Commission (ARCC) for Polio Eradication officially declared on Tuesday that the World Health Organization (WHO) African Region is free of wild poliovirus.

This marks the eradication of the second virus from the face of the continent since smallpox 40 years ago.

“Today is a historic day for Africa. The African Regional Certification Commission for Polio eradication (ARCC) is pleased to announce that the Region has successfully met the certification criteria for wild polio eradication, with no cases of the wild poliovirus reported in the Region for four years,” said Professor Rose Gana Fomban Leke, ARCC Chairperson.

The ARCC’s decision comes after an exhaustive, decades-long process of documentation and analysis of polio surveillance, immunization and laboratory capacity of the region’s 47 member states, which included conducting field verification visits to each country.

In 1996, African Heads of State committed to eradicate polio during the Thirty-Second Ordinary Session of the Organization of African Unity in Yaoundé, Cameroon. At the time, polio was paralyzing an estimated 75,000 children, annually, on the African continent.

In the same year, Nelson Mandela with the support of Rotary International jumpstarted Africa’s commitment to polio eradication with the launch of the Kick Polio Out of Africa campaign. Mandela’s call mobilized African nations and leaders across the continent to step up their efforts to reach every child with polio vaccine.

The last case of wild poliovirus in the region was detected in 2016 in Nigeria. Since 1996, polio eradication efforts have prevented up to 1.8 million children from crippling life-long paralysis and saved approximately 180,000 lives.

“This is a momentous milestone for Africa. Now future generations of African children can live free of wild polio,” said Dr Matshidiso Moeti, WHO Regional Director for Africa. “This historic achievement was only possible thanks to the leadership and commitment of governments, communities, global polio eradication partners and philanthropists. I pay special tribute to the frontline health workers and vaccinators, some of whom lost their lives, for this noble cause.”

“However, we must stay vigilant and keep up vaccination rates to avert a resurgence of the wild poliovirus and address the continued threat of the vaccine-derived polio,” said Dr Moeti.

While the eradication of wild poliovirus from the WHO African Region is a major achievement, 16 countries in the region are currently experiencing cVDPV2 outbreaks, which can occur in under-immunized communities.

“Africa has demonstrated that despite weak health systems, significant logistical and operational challenges across the continent, African countries have collaborated very effectively in eradicating wild poliovirus,” said Dr Pascal Mkanda, Coordinator of WHO Polio Eradication Programme in the African Region.

“With the innovations and expertise that the polio programme has established, I am confident that we can sustain the gains, post-certification, and eliminate cVDPV2,” added Dr Mkanda.

“The expertise gained from polio eradication will continue to assist the African region in tackling COVID-19 and other health problems that have plagued the continent for so many years and ultimately move the continent toward universal health coverage. This will be the true legacy of polio eradication in Africa,” said Dr Moeti.

Thanks to the dedication of the Global Polio Eradication Initiative, polio cases have reduced by 99.9% since 1988, bringing the world closer than ever before to ending polio. The initiative is a public-private global partnership comprising national governments; WHO; Rotary International; the United States Centers for Disease Control and Prevention; UNICEF; the Bill & Melinda Gates Foundation; Gavi, the Vaccine Alliance; and a broad range of long-term supporters.

About poliovirus
Polio is a viral disease that is transmitted from person to person, mainly through a faecal-oral route or, less frequently, through contaminated water or food, and multiplies inside the intestines.

While there is no cure for polio, the disease can be prevented through the administration of a simple and effective vaccine. That is why efforts are underway across every country to rapidly boost immunity levels in children and protect them from polio paralysis.

About the ARCC
The WHO Regional Director for Africa appointed the 16-member Africa Regional Certification Commission for Polio Eradication in 1998 with the mandate to oversee the certification process and act as the only body to certify the African Region to have eradicated the wild poliovirus.

About circulating vaccine-derived poliovirus in the African Region

While rare, vaccine-derived polioviruses cases can occur when the weakened live virus in the oral polio vaccine passes among under-immunized populations and, over time, changes to a form that can cause paralysis. If a population is adequately immunized with polio vaccines, it will be protected from both wild polio and circulating vaccine-derived polioviruses.

The 16 countries in Africa currently affected by circulating vaccine-derived polioviruses outbreaks include: Angola, Benin, Burkina Faso, Cameroon, Central African Republic, Chad, Côte d’Ivoire, the Democratic Republic of the Congo, Ethiopia, Guinea, Ghana, Mali, Niger, Nigeria, Togo and Zambia.

Responding to circulating vaccine-derived polioviruses

To address the growing challenge of circulating vaccine-derived polioviruses, the GPEI’s new ‘Strategy for the Response to Type 2 Circulating Vaccine-Derived Poliovirus 2020-2021’ is focused on working with affected and at-risk countries to control circulating vaccine-derived polioviruses outbreaks ongoing across the African Region.

The first stage of this targeted strategy involved launching a rapid response team specifically to respond to circulating vaccine-derived polioviruses. Formed in September 2019, the team is coordinated from WHO’s Regional Office for Africa in Brazzaville and is composed of 20 experts in operations and vaccination management, epidemiology, logistics, and communications, drawn from GPEI’s core partners.

Even one case is an outbreak which requires immediate action. Every time a new polio outbreak is confirmed or even suspected in the African Region, the team is dispatched to the country within 72 hours. They quickly get to work, putting together the building blocks in place for a six-month outbreak response. Outbreaks are usually rapidly stopped with 2 to 3 rounds of high quality supplementary immunizations.

Brazzaville, 21 January 2021 – While the development and approval of safe and effective vaccines less than a year after the emergence of COVID-19 is a stunning achievement, Africa is in danger of being left behind as countries in other regions strike bilateral deals, driving up prices.

As of early this week 40 million COVID-19 vaccine doses have been administered in 50 mostly high-income countries. However, in Africa, Guinea is the sole low-income nation to provide vaccines and to date these have only been administered to 25 people. Seychelles, which is a high-income country, is the only one on the continent to start a national vaccination campaign.

“We first, not me first, is the only way to end the pandemic. Vaccine hoarding will only prolong the ordeal and delay Africa’s recovery. It is deeply unjust that the most vulnerable Africans are forced to wait for vaccines while lower-risk groups in rich countries are made safe,” said Dr Matshidiso Moeti, the World Health Organization (WHO) Regional Director for Africa. “Health workers and vulnerable people in Africa need urgent access to safe and effective COVID-19 vaccines.”

The COVAX Facility – which is co-led by the Coalition for Epidemic Preparedness Innovations (CEPI), Gavi, the Vaccine Alliance, and WHO – has secured 2 billion doses of vaccine from five producers, with options for over 1 billion more doses.

“COVAX is on track to start delivering vaccine doses and begin ensuring global access to vaccines, said Thabani Maphosa, Managing Director, Country Programmes, GAVI.” This massive international undertaking has been made possible thanks to donations, work towards dose-sharing deals and deals with manufacturers that have brought us to almost 2 billion doses secured. We look forward to rollout in the coming weeks.”

In Africa, the coalition has committed to vaccinating at least 20% of the population by the end of 2021 by providing a maximum of 600 million doses based on two doses per individual disbursed in phases. An initial 30 million doses are expected to start arriving in countries by March with the aim of covering 3% of the general population, prioritizing mainly healthcare workers and other priority groups and then expanding to cover additional vulnerable groups, such as the elderly and those with pre-existing conditions. Most of the doses are expected to arrive in the second half of the year. These timelines and quantities could change if candidate vaccines fail to meet regulatory approval or production, delivery and funding face challenges.

To make sure that vaccines are transported and stored adequately to remain effective, WHO, Gavi, UNICEF and other partners are working with countries to support their readiness to receive vaccines by mapping existing cold chain equipment and storage capacity as well as providing technical support for countries to be ready to receive and manage the vaccines.

According to the WHO vaccine introduction readiness assessment tool, African nations are on average 42% ready for their mass-vaccination campaigns, which is an improvement on the starting point of 33% two months ago. However, there is still a long way to go to reach the desired benchmark of 80%.

As the largest vaccine buyer in the world, procuring more than 2 billion doses annually for routine immunization and outbreak response on behalf of nearly 100 countries, UNICEF is coordinating and supporting the procurement, international freight and delivery of COVID-19 vaccines for the COVAX Facility. This is the biggest, most sophisticated ground operation in the history of immunization. UNICEF is stockpiling one billion syringes and buying 10 million safety boxes so that used syringes and needles can be disposed in a safe manner by personnel at health facilities, thus preventing the risk of injuries and blood borne diseases.

“UNICEF has put in place a global network of freight forwarders and logistics providers to deliver vaccines as quickly and safely as possible as part of this historic and mammoth operation,” said Mohamed Fall, UNICEF Eastern and Southern Africa Regional Director. “This invaluable collaboration will ensure that we have enough transport capacity in place for delivering COVID-19 vaccine doses, syringes and safety boxes to the front-line workers who ultimately protect the millions of children who depend on their vital services.”

All the 54 countries on the continent have expressed interest in the COVAX Facility.  Eight higher and middle-income countries will self-finance their own participation, while lower-middle income and low-income countries will access the vaccines at no cost through the Facility. The vaccines distributed by COVAX will have received WHO Emergency Use Listing authorization and as such will have undergone stringent validation of their safety and effectiveness. However, vaccine nationalism is threatening the COVAX initiative.

The COVAX initiative has raised US $6 billion in pledges but needs an additional US $2.8 billion in 2021 and WHO and partners are urging countries and donors to contribute and help end the pandemic globally.

Dr Moeti spoke during a virtual press conference today facilitated by APO Group. She was joined by Thabani Maphosa, Managing Director, Country Programmes, GAVI, and Mohamed Fall, UNICEF Eastern and Southern Africa Regional Director.

(END)

CINCINNATI, April 12, 2021 — Airway Therapeutics, Inc., a biopharmaceutical company developing a new class of biologics to break the cycle of injury and inflammation for patients with respiratory and inflammatory diseases, today announced the U.S. Food and Drug Administration (FDA) has accepted its Investigational New Drug (IND) application to develop AT-100 (rhSP-D) as a treatment for COVID-19. Airway is leveraging the FDA’s Coronavirus Treatment Acceleration Program (CTAP) that is aimed at evaluating new treatment options for COVID-19.

Airway will initiate a Phase 1b clinical trial to confirm the feasibility of intratracheal administrations of AT-100 and its beneficial safety and tolerability profile.

Airway’s novel human recombinant protein AT-100 – an engineered version of an endogenous protein – has been shown in preclinical studies to safely reduce inflammation and infection while modulating the immune response across a range of respiratory diseases inside and outside the lung. Additionally, preclinical studies of AT-100 have shown potential to inhibit SARS-CoV-2 replication and promote viral elimination. AT-100 may also reduce secondary infections in severe COVID-19 patients who are mechanically ventilated in intensive care. This multidimensional approach differentiates AT-100 from other COVID-19 treatments in development.

“The pre-clinical data are encouraging and lead us to believe that AT-100 has therapeutic potential against COVID-19 by reducing infection and inflammation in mechanically ventilated seriously-ill patients who require a range of treatment options,” said Marc Salzberg, M.D., CEO of Airway. “We are excited to advance the clinical development of AT-100 with the goal of delivering a novel therapy for severely ill COVID-19 patients who are in need of new treatment options.”

In March, the FDA approved Airway’s first IND application to develop AT-100 as a preventive treatment for the serious respiratory disease bronchopulmonary dysplasia (BPD) in very preterm infants. The Phase 1b clinical trial will begin later this month.

About AT-100
AT-100 is a novel recombinant human protein rhSP-D, an engineered version of an endogenous protein that reduces inflammation and infection in the body while modulating the immune response to break the cycle of injury and inflammation. Airway is focused on advancing AT-100 for the prevention of BPD in very preterm born babies and as a therapeutic for seriously ill COVID-19 patients. AT-100’s anti-inflammatory and anti-infective properties also make it a potential treatment for other respiratory diseases such as influenza, respiratory syncytial virus (RSV) and inflammatory diseases outside the lung. The FDA and European Medicines Agency have granted AT-100 Orphan Drug Designation.

About Airway Therapeutics
Airway Therapeutics is a biopharmaceutical company developing a new class of biologics to break the cycle of injury and inflammation for patients with respiratory and inflammatory diseases, beginning with the most vulnerable populations. The company is advancing the novel recombinant human protein rhSP-D, an engineered version of an endogenous protein that reduces inflammation and infection in the body while modulating the immune response. AT-100 is Airway’s first candidate in development for prevention of BPD in very preterm infants and for treatment of COVID-19 in seriously ill mechanically ventilated patients. To learn more, visit https://www.airwaytherapeutics.com.

Logo – https://mma.prnewswire.com/media/1122328/Airway_Therapeutics_Logo.jpg

CONTACT: Meghan Riley, riley@airwaytherapeutics.com

SOURCE Airway Therapeutics, Inc.

DUBLIN, – Allergan plc today confirmed that it has been approached by Pfizer Inc. and is in preliminary friendly discussions regarding a potential business combination transaction. Allergan stated that no agreement has been reached and there can be no certainty that these discussions will lead to a transaction, or as to the terms on which a transaction, if any, might be agreed. The company will not comment on speculation regarding the terms of a potential transaction.

Under any potential scenario with Pfizer, Allergan remains strongly committed to complete the proposed divestment of its global generics business to Teva Pharmaceutical Industries Ltd and expects the generics divestiture transaction to close in the first quarter of 2016.

A further announcement will be made when appropriate.

About Allergan plc
Allergan plc (NYSE: AGN), headquartered in Dublin, Ireland, is a unique, global pharmaceutical company and a leader in a new industry model – Growth Pharma. Allergan is focused on developing, manufacturing and commercializing innovative branded pharmaceuticals, high-quality generic and over-the-counter medicines and biologic products for patients around the world.

Allergan markets a portfolio of best-in-class products that provide valuable treatments for the central nervous system, eye care, medical aesthetics, gastroenterology, women’s health, urology, cardiovascular and anti-infective therapeutic categories, and operates the world’s third-largest global generics business, providing patients around the globe with increased access to affordable, high-quality medicines. Allergan is an industry leader in research and development, with one of the broadest development pipelines in the pharmaceutical industry and a leading position in the submission of generic product applications globally.

PHOENIX– New public opinion survey results announced today in conjunction with the start of the Assisted Living Federation of America’s (ALFA) 2014 Conference & Exposition reveal that those selecting a senior living community for themselves or a loved one place a high priority on cleanliness, healthy and convenient food options, and hotel-like amenities.

With an estimated 70 percent of people who reach age 65 needing some form of long-term service and support1, Ecolab Inc. recently commissioned a survey of 400 Americans involved in selecting senior living communities to determine how these decisions are made, the factors that influence these decisions, and the expectations for services and amenities offered by senior living communities.

“Choosing a community for a loved one is highly emotional. In fact, more than half of the respondents reported that this was one of the most emotional decisions they’ve ever made,” said Leah Larson, director of Long Term Care Marketing for Ecolab’s Institutional business. “And, with 10,000 people turning 65 years old today, and every day until the year 2029, exponentially more people will make these important decisions each day.”

First Impressions Count: 93 Percent Say Cleanliness Linked to Quality of Care
When asked whether they agreed that “If a community isn’t clean, it suggests to me that the staff might not take good care of the residents,” 93 percent agreed. Moreover, 96 percent ranked “cleanliness” as important or extremely important when choosing a senior living community; women are twice as likely as men to say cleanliness is their top priority.

“This research confirmed what we intuitively know to be true. First impressions count, especially when it comes to cleanliness,” said Larson. “Ecolab’s field sales-and-service teams and research and development experts work inside customer locations, alongside housekeeping, laundry and foodservice staffs, to learn about and develop solutions for the unique cleaning and sanitizing challenges in senior living communities.”

Larson added that cleaning a resident’s room is similar in process to cleaning a hotel room, but more challenging in that special consideration must be given to the presence of residents and their personal belongings. In addition, a focus on infection prevention is of higher importance due to potentially compromised immune systems.

Concerning laundry, Larson added that resident skin sensitivity may be an issue, so it’s important to have the right laundry solution to help reduce the occurrences of bed sores. Finally, she said overall cleanliness has a direct correlation to both the perception of care and the actual delivery of a positive resident experience.

“This depth of knowledge allows us to personally train staffs across several areas of the facility about: 1) housekeeping protocols and products that efficiently and effectively clean and disinfect rooms; 2) laundry wash processes and chemistry that help keep linens clean, while helping to reduce skin irritations for residents and the cost of linen replacement for management; and 3) food safety and kitchen cleaning and sanitizing procedures and products to help reduce the risk of foodborne illness, while achieving commercial kitchen sanitation levels and spotless tableware for residents and guests.”

High Expectations for Healthy, Convenient Foods: 71 Percent Want Room Service
The survey also showed that senior living communities today are expected to offer fresh, healthy foods along with convenience. In fact, 85 percent of respondents ranked quality and variety of food as important. They also had high expectations for specific food and dining options in senior living communities, reminiscent of what might be found in a hotel. For instance, 71 percent want room service, 66 percent expect a coffee shop, 78 percent expect a bakery or fresh baked goods and desserts, and 82 percent expect a fresh salad bar. About 20 percent expect access to an on-site bar or pub.

Hillcrest Health Services, near Omaha, Neb., an organization serving aging adults that utilizes Ecolab products and solutions in their foodservice, housekeeping and laundry operations, is an example of how these hotel-like foodservice expectations are being brought to life.

“Our ‘Culinary Vision’, which includes in-room dining services, multiple dining room options and an eat-in bistro with made-to-order specialties, centers around the concept of providing patients and residents choices about when, where and what they can eat while they are staying with us,” said Tim Irwin, Hillcrest’s vice president of Operations. “In the near future, we’ll again offer a bistro and resort-style dining – as well as an on-site pub – at our new Grand Lodge.”

Bring on the “Extras”
When asked to rank a list of features in order of priority when considering an independent or assisted living community, answers varied depending upon whether the respondents were making the decision for themselves or a loved one.

For those making decisions as the resident, comfort and ambiance of their living space ranked number one, followed by services and amenities and safe layout. If making the decision for someone else, a caring staff ranked at the top of the list.

Regardless of the role of the respondent, when asked about the importance of several services and amenities, many said frequency of cleaning/laundry services (82 percent) is a priority, as is in-house exercise and recreational activities (72 percent) and access to in-room WiFi (43 percent).
“This research indicates that one size does not fit all when it comes to selecting a senior living community, and different decision makers have different priorities,” said Larson.

“What does all this mean? First, for our company, we need to continue innovating products and educating our customers around maintaining the highest standards of cleanliness – as it is one of the most important factors in selecting a senior living community. Second, our customers should continue to invest in creating vibrant senior living communities that deliver on the higher expectations of this generation. And finally, the long-term care industry needs to find ways to differentiate independent and assisted living from nursing care, and increase awareness about the opportunity to maintain a vibrant lifestyle as the need for senior living communities skyrockets in the near future.”

To learn more about Ecolab’s custom solutions in the long term care industry, as well as other key market segments such as foodservice, lodging and facility care, visit www.ecolab.com.

About Ecolab
A trusted partner at more than one million customer locations, Ecolab (ECL) is the global leader in water, hygiene and energy technologies and services that protect people and vital resources. With 2013 sales of $13 billion and 45,000 associates, Ecolab delivers comprehensive solutions and on-site service to promote safe food, maintain clean environments, optimize water and energy use and improve operational efficiencies for customers in the food, healthcare, energy, hospitality and industrial markets in more than 170 countries around the world. For more Ecolab news and information, visit www.ecolab.com.

About Hillcrest Health Services
Hillcrest Health Services offers the region’s largest continuum of health services for aging adults, including independent and assisted living, in-patient and outpatient rehabilitation, long-term care, memory support, adult day services, certified skilled home health and private duty home care, palliative care, telehealth services, and hospice care. Hillcrest currently serves nearly 1,000 aging adults daily across eight counties in Nebraska and Iowa. For more information, visit www.hillcresthealth.com or call (402) 682-4800.

Indianapolis, Ind. and Bloomfield, Conn. – July 24, 2015 – Anthem, Inc. (NYSE: ANTM) and Cigna Corporation (NYSE: CI) today announced that they have entered into a definitive agreement whereby Anthem will acquire all outstanding shares of Cigna in a cash and stock transaction and Cigna shareholders will receive $103.40 in cash and 0.5152 Anthem common shares for each Cigna common share. The total per share consideration equates to approximately $188.00 for each Cigna share based on Anthem’s closing share price on May 28, 2015, valuing the transaction at $54.2 billion on an enterprise basis.

The combined company will be an industry leader with enhanced diversification and capabilities to advance the transformation of health care delivery for consumers.
Following the transaction, Anthem will have more than $115 billion in pro forma annual revenues, based on the most recent 2015 outlooks publicly reported by both companies and will gain meaningful diversification covering approximately 53 million medical members with well positioned commercial, government, consumer, specialty and
international franchises. Upon the close of the transaction, Joseph Swedish will serve as Chairman and Chief Executive Officer of the combined company and David Cordani will be President and Chief Operating Officer. In addition, effective upon closing, the Anthem Board of Directors will be expanded to 14 members. David Cordani and four independent directors from Cigna’s current Board of Directors will join the nine current members of the Anthem Board of Directors.

The agreement provides an “unaffected” premium to Cigna’s shareholders of approximately 38.4%, based on the unaffected closing price of Cigna’s shares on May 28, 2015. Under the terms of the transaction, the consideration consists of approximately 55% cash and 45% Anthem shares, and the combined company would reflect a pro forma equity ownership comprised of approximately 67% Anthem shareholders and approximately 33% Cigna shareholders.

“We are very pleased to announce an agreement that will deliver meaningful value to consumers and shareholders through expanded provider collaboration, enhanced affordability and cost of care management capabilities, and superior innovations that deliver a high quality health care experience for consumers. We believe that this transaction will allow us to enhance our competitive position and be better positioned to apply the insights and access of a broad network and dedicated local presence to
the health care challenges of the increasingly diverse markets, membership, and communities we serve.

The Cigna team has built a set of capabilities that greatly complement our own offerings and the combined company will have a competitive presence across commercial, government, international and specialty segments. These expanded capabilities will enable us to better serve our customers as their health care needs evolve,” said Joseph Swedish, President and Chief Executive Officer of Anthem.

“Our companies share proud histories and an even brighter future. Going forward our new company will deliver an acceleration of innovative and affordable health and protection benefits solutions that help address our health system’s challenges and provide supplemental insurance protection, and health care security to consumers, their families, and the communities we share with them. The complementary nature of our businesses will allow us to leverage the deep global health care knowledge, local market talent, and expertise of both organizations to ensure that consumers have access to affordable and personalized solutions across diverse life and health stages and position us for sustained success,” said David M. Cordani, President and Chief Executive Officer of Cigna.

Utilizing Anthem’s and Cigna’s complementary strengths, the combined company will be able to deliver higher quality health care as America’s valued health partner. By combining Anthem’s Blue Cross and Blue Shield footprint in 14 states and Medicaid footprint via its Amerigroup brand in 19 states with Cigna’s broad portfolio of health and protection services in the U.S. and globally, the combined company will offer a comprehensive range of high quality, high value products and services to the full spectrum of customers – individuals, employers and State and Federal governments.

The transaction is expected to close in the second half of 2016, pending the receipt of customary approvals, including certain state regulatory approvals and expiration of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act. In addition, the transaction is subject to customary closing conditions, including the approval of Cigna’s shareholders of the merger agreement and Anthem’s shareholders of the issuance of shares in the transaction. Anthem is confident in its ability to
obtain all necessary regulatory and other approvals.

The combined company expects to achieve adjusted earnings per share accretion approaching 10% in year one, with the accretion more than doubling by year two following the closing of the transaction.

We are confident in our ability to achieve synergy targets and are committed to retaining investment grade debt ratings. Anthem expects its debt-to-capital ratio to be approximately 49% at the time of close, with a plan to bring the ratio down to the low 40% range within 24 months. Anthem has received committed financing from Bank of America, Credit Suisse and UBS Investment Bank in connection with the transaction.

CUPERTINO, California— Apple® today announced ResearchKit™, a software framework designed for medical and health research that helps doctors, scientists and other researchers gather data more frequently and more accurately from participants using mobile devices, is now available to researchers and developers. The first research apps developed using ResearchKit study asthma, breast cancer, cardiovascular disease, diabetes and Parkinson’s disease, and have enrolled over 60,000 iPhone® users in just the first few weeks of being available on the App Store™.* Starting today, medical researchers all over the world will be able to use ResearchKit to develop their own apps and developers can also contribute new research modules to the open source framework.

“We are delighted and encouraged by the response to ResearchKit from the medical and research community and the participants contributing to medical research. Studies that historically attracted a few hundred participants are now attracting participants in the tens of thousands,” said Jeff Williams, Apple’s senior vice president of Operations. “Medical researchers all over the world are actively exploring how ResearchKit can help them study even more diseases, and we believe the impact on global understanding of health and wellness will be profound.”

The open source framework allows any medical researcher to take advantage of the initial modules in ResearchKit to study health and wellness and better understand disease. Developers can also build new modules based on the open source code and contribute them to ResearchKit. The initial customizable modules address the most common elements found in research studies—participant consent, surveys and active tasks.
Participant consent: Participant consent is a critical element to research studies, and with ResearchKit researchers can access a visual e-consent template that can be customized to explain the details of the study and obtain participant signatures. This module makes it easy for the researcher to include elements such as video segments explaining the study and an interactive quiz to confirm the participant’s understanding.
Surveys: The survey module provides a pre-built user interface that makes it easy to customize questions and answers for study participants to complete and immediately share with researchers.
Active Tasks: The Active Task module enables researchers to gather more targeted data for their study by inviting participants to perform activities that generate data using iPhone’s advanced sensors. Initial Active Task modules include tasks to measure motor activities, fitness, cognition and voice, and with the framework available as open source, the research community can contribute even more active tasks to ResearchKit.

“ResearchKit could help us reach people all over the world who are willing to contribute to medical research, but might not know how or be able to get involved,” said Ricky Bloomfield, Director of Mobile Technology Strategy and Assistant Professor in Internal Medicine & Pediatrics at Duke University. “Our team of researchers is now launching the development of an exciting new study using the ResearchKit framework, which will enable us to gather data quickly, from more participants than we are typically able to reach.”

“Because of the ubiquity of iPhone and the elegant implementation of consent, survey and instrumented data collection, ResearchKit has enormous promise for leading the transformation of how we engage patients in research,” said Kenneth Mandl, MD, MPH, of the Boston Children’s Hospital Informatics Program. “Now that we have access to the ResearchKit framework, our team can start customizing the initial modules and even design new ones for our particular study.”

ResearchKit turns iPhone into a powerful tool for medical research. When granted permission by the participant, ResearchKit apps can access data from advanced iPhone sensors like the accelerometer, gyroscope, microphone and GPS to gain insight into a participant’s activity levels, motor impairments, memory and more. ResearchKit works seamlessly with HealthKit™, a software framework Apple introduced with iOS 8 to provide developers the ability for health and fitness apps to communicate with each other. With permission from the participant, ResearchKit apps can access and use data from the Health app such as weight, blood pressure, glucose levels and asthma inhaler use, which are measured by third-party devices and apps.

For more information on ResearchKit, visit www.apple.com/researchkit and for details on how to access the open source framework, visit www.researchkit.org.

*ResearchKit apps are available on the App Store in the US at www.appstore.com/researchkit and will be rolling out to more countries in the future. iPhone 5, iPhone 5s, iPhone 6, iPhone 6 Plus and the latest generation of iPod touch® support ResearchKit apps.

Apple designs Macs, the best personal computers in the world, along with OS X, iLife, iWork and professional software. Apple leads the digital music revolution with its iPods and iTunes online store. Apple has reinvented the mobile phone with its revolutionary iPhone and App Store, and is defining the future of mobile media and computing devices with iPad.

AstraZeneca is advancing its ongoing response to address the unprecedented challenges of COVID-19, collaborating with a number of countries and multilateral organisations to make the University of Oxford’s vaccine widely accessible around the world in an equitable manner.

The Company has concluded the first agreements for at least 400 million doses and has secured total manufacturing capacity for one billion doses so far and will begin first deliveries in September 2020. AstraZeneca aims to conclude further agreements supported by several parallel supply chains, which will expand capacity further over the next months to ensure the delivery of a globally accessible vaccine.

AstraZeneca today received support of more than $1bn from the US Biomedical Advanced Research and Development Authority (BARDA) for the development, production and delivery of the vaccine, starting in the fall. The development programme includes a Phase III clinical trial with 30,000 participants and a paediatric trial.

In addition, the Company is engaging with international organisations such as the Coalition for Epidemic Preparedness Innovations (CEPI), Gavi the Vaccine Alliance and the World Health Organisation (WHO), for the fair allocation and distribution of the vaccine around the world. AstraZeneca is also in discussions with governments around the world to increase access. Furthermore, AstraZeneca is in discussions with the Serum Institute of India and other potential partners to increase production and distribution.

AstraZeneca recently joined forces with the UK Government to support Oxford University’s vaccine and has progressed rapidly in its efforts to expand access around the world. The Company will supply the UK starting in September and is thankful for the Government’s commitment and overall work on vaccines.

Pascal Soriot, Chief Executive Officer, said: “This pandemic is a global tragedy and it is a challenge for all of humanity. We need to defeat the virus together or it will continue to inflict huge personal suffering and leave long-lasting economic and social scars in every country around the world. We are so proud to be collaborating with Oxford University to turn their ground-breaking work into a medicine that can be produced on a global scale. We would like to thank the US and UK governments for their substantial support to accelerate the development and production of the vaccine. We will do everything in our power to make this vaccine quickly and widely available.”

AstraZeneca has now finalised its licence agreement with Oxford University for the recombinant adenovirus vaccine. The licensing of the vaccine, formerly ChAdOx1 nCoV-19 and now known as AZD1222, follows the recent global development and distribution agreement with the University’s Jenner Institute and the Oxford Vaccine Group. AstraZeneca has also agreed to support the establishment of a joint research centre at Oxford University for pandemic preparedness research.

A Phase I/II clinical trial of AZD1222 began last month to assess safety, immunogenicity and efficacy in over 1,000 healthy volunteers aged 18 to 55 years across several trial centres in southern England. Data from the trial is expected shortly which, if positive, would lead to late-stage trials in a number of countries. AstraZeneca recognises that the vaccine may not work but is committed to progressing the clinical program with speed and scaling up manufacturing at risk.

The Company’s comprehensive pandemic response also includes rapid mobilisation of AstraZeneca’s global research efforts to discover novel coronavirus-neutralising antibodies to prevent and treat progression of the COVID-19 disease, with the aim of reaching clinical trials in the next three to five months. Additionally, the Company has quickly moved into testing of new and existing medicines to treat the infection, including CALAVI and ACCORD trials underway for Calquence (acalabrutinib) and DARE-19 trial for Farxiga (dapagliflozin) in COVID-19 patients.

Financial considerations

Today’s announcement is not anticipated to have any significant impact on the Company’s financial guidance for 2020; expenses to progress the vaccine are anticipated to be offset by funding by governments.

AZD1222

ChAdOx1 nCoV-19, now known as AZD1222, was developed by Oxford University’s Jenner Institute, working with the Oxford Vaccine Group. It uses a replication-deficient chimpanzee viral vector based on a weakened version of a common cold (adenovirus) virus that causes infections in chimpanzees and contains the genetic material of SARS-CoV-2 spike protein. After vaccination, the surface spike protein is produced, priming the immune system to attack COVID-19 if it later infects the body.

The recombinant adenovirus vector (ChAdOx1) was chosen to generate a strong immune response from a single dose and it is not replicating, so cannot cause an ongoing infection in the vaccinated individual. Vaccines made from the ChAdOx1 virus have been given to more than 320 people to date and have been shown to be safe and well tolerated, although they can cause temporary side effects such as a temperature, influenza-like symptoms, headache or a sore arm.

AstraZeneca

AstraZeneca (LSE/STO/NYSE: AZN) is a global, science-led biopharmaceutical company that focuses on the discovery, development and commercialisation of prescription medicines, primarily for the treatment of diseases in three therapy areas – Oncology, Cardiovascular, Renal & Metabolism, and Respiratory & Immunology. Based in Cambridge, UK, AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide. Please visit astrazeneca.com and follow the Company on Twitter @AstraZeneca.

LaVergne, Tenn.The McKesson Specialty Health Customer Care Contact Center has been certified as a Center of Excellence by BenchmarkPortal for the Third Party Logistics (3PL) Service Title/Non-Title business. This marks the first time that the Customer Care Contact Center in LaVergne, Tennessee has received certification. The Center of Excellence recognition is one of the most prestigious and coveted awards in the customer service and support industry.

BenchmarkPortal uses a rigorous benchmarking process to award the Center of Excellence designation to customer service call centers that are ranked in the top ten percent of call centers surveyed. Call centers are judged against a balanced scorecard of metrics for efficiency and effectiveness drawn from the world’s largest database of quantitative data audited and validated by researchers from BenchmarkPortal. Call centers earn the award by demonstrating superior performance for both cost-related and quality-related metrics when compared to industry peers.

“We are excited about receiving this honor of distinction, demonstrating that we have achieved high levels of performance and customer satisfaction. It is particularly gratifying to be recognized by BenchmarkPortal, the leading call center research consulting organization,” said Leta Gibbs, VP of Customer Care at McKesson Specialty Health. “This was a team effort, based on the success and efforts of all our internal teams, 3PL Services, pharmaceutical manufacturers and agents.”;

McKesson Specialty Health supports successful pharmaceutical commercialization through third-party logistics support services. Supporting pharmaceutical manufacturer partners and key stakeholders with the careful coordination of their specialty products through the entire product life-cycle, McKesson 3PL Services provides pharmaceutical and biotech companies with a seamless service model for patient and customer ease of access. By combining McKesson’s long-standing distribution services’ success with pharmaceutical experience, McKesson 3PL Services help pharmaceutical manufacturers deliver products accurately and on time to hospitals, physician practices, pharmacies and medical clinics.

About McKesson Specialty Health
McKesson Specialty Health, a division of McKesson Corporation, works together with stakeholders across the healthcare delivery system to preserve and strengthen specialty care, passionately driven by the benefits it provides patients and the system as a whole. Through innovative provider, practice management, biopharma and payer solutions, McKesson Specialty Health focuses on improving the financial, operational and business health of our customers and partners so they may provide the best care to patients. At McKesson Specialty Health, we believe that we are all in this together. For more information, visit www.mckessonspecialtyhealth.com.

About Center of Excellence Certification
Contact centers and their managers who wish to implement best practices and attain world-class performance in their industry have a unique opportunity to certify their call centers. BenchmarkPortal’s rigorous certification process has the advantage of referencing all performance goals to their best practice database of thousands of contact centers. Thus, contact centers will be held to performance levels that will improve their competitive position, not just force them to adhere to an arbitrary standard. Please follow the link to discover what the steps to certification are and how they will improve your center’s performance. www.benchmarkportal.com/call-center-certification.

About BenchmarkPortal
Founded in 1995, BenchmarkPortal is a global leader in the contact center industry, providing benchmarking, certification, training, consulting, research and industry reports. The BenchmarkPortal team of professionals has gained international recognition for its innovative approach to best practices for the contact center indus­try. BenchmarkPortal hosts the world’s largest database of contact center metrics, which is constantly being refreshed with new data. BenchmarkPortal’s mission is to provide contact center managers with the tools and information that will help them optimize their efficiency and effectiveness in their customer communications. For more information on BenchmarkPortal please call 1-800-214-8929 or visit www.BenchmarkPortal.com.

Chicago, Illinois – Boston Children’s Hospital and GE Healthcare today announced a collaboration to develop and commercialize digital solutions to advance the diagnosis and treatment of specific childhood diseases – starting with diseases that affect the brain. The first project, detailed today at the 102nd annual meeting of the Radiological Society of North America in Chicago, Ill., seeks to improve diagnostic accuracy in pediatric brain scans by providing real-time contextual information at the time and place the radiologist needs it.

Every day, tens of thousands of children undergo medical imaging. At Boston Children’s alone, nearly 1,000 imaging studies are performed each day. For general radiologists and pediatric imagers alike, the rapid changes in the body that occur as part of normal childhood development can pose challenges to accurately differentiate normal from abnormal. Keeping up with the ever-growing litany of specific diagnoses can frustrate even the most experienced of radiologists.

Leveraging the software expertise of GE Healthcare, the high-volume computing power of the GE Health Cloud and the clinical knowledge of radiologists at Boston Children’s, the two organizations are working to develop a decision support platform that is intended to help distinguish the large variability in brain MRI scans.

The system will be pre-loaded with normative reference scans from young children of different ages for doctors worldwide to use as a benchmark when reading scans of pediatric patients.

“Interpreting pediatric brain scans requires a specific understanding of the developing brain,” said Richard Robertson, MD, radiologist-in-chief at Boston Children’s. “Since most pediatric imaging is not performed in children’s hospitals by specialists, this new digital tool, once available, will provide non-specialists with access to knowledge and expertise to help effectively diagnose children. We believe that by providing decision support at the time of interpretation, we can improve both the confidence and performance of the interpreting radiologist.”

Ad hoc image databases are often limited to the pediatric departments of major academic institutions. General radiologists without access to such databases lack large reference points and context, which could lead to potential misdiagnosis. Changes in myelination occurring during the first few years of life are particularly likely to be confused with disease states or, conversely, may lead to misinterpretation of the exam as normal for the patient when the abnormality is symmetric in the brain.

“Pediatric brain scans of children under the age of four can be particularly tricky to read because the brain is rapidly developing during this period of childhood,” said Sanjay Prabhu, MBBS, pediatric neuroradiologist at Boston Children’s. “Since pediatric neuroradiologists are very scarce, we approached GE Healthcare to collaborate on the development of digital tools to help physicians of varying expertise read the scans.”

During infancy and childhood, complicated disorders, especially when affecting the brain symmetrically, may be misinterpreted as normal brain maturation. Conversely, normal expected developmental changes are sometimes misinterpreted as pathologic leading to unnecessary follow-on imaging or other diagnostic tests, which can be expensive, stressful and inconvenient to the child and family.

“This brain app that we are targeting to develop will be the first of many digital tools we are creating for our deep learning library, said Charles Koontz, chief digital officer, GE Healthcare. “By 2020, we’ll have hundreds of apps in the GE Health Cloud, enabling insights that will transform healthcare in each disease area and help the seven billion people on earth.”

Boston Children’s is participating via its Innovation and Digital Health Accelerator (IDHA), led by Jean Mixer, VP Strategy and Digital Health, and John Brownstein, PhD, Chief Innovation Officer. IDHA seeks to enable clinicians anywhere in the world to access the hospital’s expertise and data in rare and complex pediatric care through digital tools.

About Boston Children’s Hospital
Boston Children’s Hospital is home to the world’s largest research enterprise based at a pediatric medical center, where its discoveries have benefited both children and adults since 1869. More than 1,100 scientists, including seven members of the National Academy of Sciences, 11 members of the Institute of Medicine and 10 members of the Howard Hughes Medical Institute comprise Boston Children’s research community. Founded as a 20-bed hospital for children, Boston Children’s today is a 404-bed comprehensive center for pediatric and adolescent health care. Boston Children’s is also the primary pediatric teaching affiliate of Harvard Medical School. For more, visit our Vector and Thriving blogs and follow us on our social media channels: @BostonChildrens, @BCH_Innovation, Facebook and YouTube.

About GE Healthcare
GE Healthcare provides transformational medical technologies and services to meet the demand for increased access, enhanced quality and more affordable healthcare around the world. GE Healthcare (GE) works on things that matter – great people and technologies taking on tough challenges. From medical imaging, software & IT, patient monitoring and diagnostics to drug discovery, biopharmaceutical manufacturing technologies and performance improvement solutions GE Healthcare helps medical professionals deliver great healthcare to their patients. http://www.gehealthcare.com

DUBLIN and WESTLAKE VILLAGE, Calif., June 17, 2015 — Allergan plc (NYSE: AGN), a leading global pharmaceutical company, and KYTHERA Biopharmaceuticals, Inc. (NASDAQ: KYTH), a biopharmaceutical company focused on the discovery, development and commercialization of novel prescription products for the aesthetic medicine market, today announced that they have entered into a definitive agreement under which Allergan has agreed to acquire KYTHERA in a cash and equity transaction valued at $75 per KYTHERA share, or approximately $2.1 billion, subject to the fulfillment of certain customary conditions summarized below. The fixed-value transaction consideration will be payable 80 percent in cash and 20 percent in new AGN shares issued to KYTHERA shareholders. Allergan’s 2015 earnings-per-share forecast provided on May 11, 2015 is unchanged as a result of the acquisition. The acquisition is expected to be breakeven in 2016 and accretive thereafter. The Company remains committed to de-levering to below 3.5x debt to Adjusted EBITDA by the end of the first quarter of 2016.

The acquisition of KYTHERA immediately enhances Allergan’s global facial aesthetics portfolio with the addition of KYBELLA™ (deoxycholic acid) injection, the first and only approved non-surgical treatment for contouring moderate to severe submental fullness, commonly referred to as double chin. KYBELLA™ was approved by the U.S. Food and Drug Administration (FDA) on April 29, 2015. KYBELLA™ injection is also being developed for potential introduction into international markets; KYTHERA has submitted KYBELLA™ injection for regulatory approval in Switzerland, Canada and Australia, with other market applications to follow. The acquisition will also add KYTHERA’s development product setipiprant (KYTH-105), a novel compound for the prevention of male pattern baldness, as well as additional early-stage development candidates.

“The acquisition of KYTHERA is a strategic investment that strengthens our leading global position in aesthetics and continues to position us for long-term growth,” said Brent Saunders, CEO and President of Allergan. “KYBELLA™ is an exciting new product that offers patients the first and only clinically-proven, non-surgical treatment for submental fullness (excess fat under the chin). As a leader in aesthetics, we know our customers are looking to offer their patients new options beyond traditional facial aesthetics. KYBELLA™ will do that while complementing our market leading facial aesthetics portfolio, which includes BOTOX®, JUVEDERM® XC, JUVEDERM VOLUMA® XC, LATISSE® and SKINMEDICA. KYBELLA™ is also a pivotal entry point for expanding the use of facial aesthetic products in men, while KYTHERA’s setipiprant (hair-loss) development program can drive additional long-term value.”

“Allergan’s world-class medical aesthetics, global footprint, history and commitment to developing leading aesthetic products makes them ideally suited to realize the maximum commercial potential of KYBELLA™,” said Keith Leonard, CEO and President of KYTHERA. “I am deeply appreciative of the commitment and dedication of our KYTHERA team that worked so tirelessly to bring KYBELLA™ from early development through approval and launch. We look forward to working with Allergan to ensure a successful U.S. launch of KYBELLA™, as well as to secure additional approvals globally.”

Submental fullness is a common yet undertreated condition that can detract from an otherwise balanced and harmonious facial appearance – leading to an older and heavier look. Submental fullness can affect adults – both women and men – of all ages, weight and gender. Influenced by multiple factors including aging and genetics, submental fullness is often resistant to diet and exercise. According to a 2015 survey by the American Society for Dermatologic Surgery, 67 percent of consumers are bothered by submental fullness.i

KYTHERA is executing a training-led launch in the U.S. supported by a training program designed to educate physicians and qualified injectors on the safe use of KYBELLA™ and its approved indication. Physician faculty education in the U.S. began in June 2015. KYBELLA™ physician training programs will initiate in late summer. Qualified injectors in the U.S. will be able to purchase KYBELLA™ and treat their patients after they have been trained.

Allergan’s acquisition of KYTHERA is subject to approval by the shareholders of KYTHERA, expiration or termination of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976 and fulfillment of certain other customary conditions to closing. Pending such approvals and fulfillment of other conditions, Allergan currently anticipates closing the transaction in the third quarter of 2015.

J.P. Morgan is serving as financial advisor to Allergan and Covington & Burling LLP is serving as Allergan’s lead legal counsel. Goldman Sachs is serving as financial advisor to KYTHERA and Latham & Watkins LLP is serving as KYTHERA’s lead legal counsel.

About KYBELLA™
KYBELLA™ is the first and only approved non-surgical treatment for contouring moderate to severe submental fullness, commonly referred to as double chin. KYBELLA™ is a non-human and non-animal formulation of deoxycholic acid, a naturally-occurring molecule in the body that aids in the breakdown and absorption of dietary fat. When injected into subcutaneous fat, KYBELLA™ causes the destruction of fat cells. Once destroyed, those cells cannot store or accumulate fat.

KYBELLA™ (deoxycholic acid) injection is indicated for improvement in the appearance of moderate to severe convexity or fullness associated with submental fat in adults.

The safe and effective use of KYBELLA for the treatment of subcutaneous fat outside the submental region has not been established and is not recommended.

Important Safety Information
KYBELLA should only be administered by a trained healthcare professional.

KYBELLA is contraindicated in the presence of infection at the injection sites.

Avoid injecting in proximity to vulnerable anatomic structures due to the increased risk of tissue damage.

Cases of marginal mandibular nerve injury, manifested as an asymmetric smile or facial muscle weakness, were reported during clinical trials. To avoid the potential for nerve injury, KYBELLA should not be injected into or in close proximity to the marginal mandibular branch of the facial nerve. All marginal mandibular nerve injuries reported from the trials resolved spontaneously (range 1-298 days, median 44 days).

Difficulty swallowing (dysphagia) occurred in the clinical trials in the setting of administration site reactions, e.g., pain, swelling, and induration of the submental area. Cases of dysphagia spontaneously resolved (range 1-81 days, median 3 days). Subjects with current or prior history of dysphagia were excluded from clinical trials. Avoid use of KYBELLA in these patients as current or prior history of dysphagia may exacerbate the condition.

In clinical trials, 72% of subjects treated with KYBELLA experienced injection site hematoma/bruising. KYBELLA should be used with caution in patients with bleeding abnormalities or who are currently being treated with antiplatelet or anticoagulant therapy as excessive bleeding or bruising in the treatment area may occur.

To avoid the potential of tissue damage, KYBELLA should not be injected into or in close proximity (1-1.5 cm) to salivary glands, lymph nodes and muscles.

The most commonly reported adverse reactions in the pivotal clinical trials were: injection site edema/swelling, hematoma/bruising, pain, numbness, erythema, and induration.

About Allergan
Allergan plc (NYSE: AGN), headquartered in Dublin, Ireland, is a unique, global pharmaceutical company and a leader in a new industry model – Growth Pharma. Allergan is focused on developing, manufacturing and commercializing innovative branded pharmaceuticals, high-quality generic and over-the-counter medicines and biologic products for patients around the world.

Allergan markets a portfolio of best-in-class products that provide valuable treatments for the central nervous system, eye care, medical aesthetics, gastroenterology, women’s health, urology, cardiovascular and anti-infective therapeutic categories, and operates the world’s third-largest global generics business, providing patients around the globe with increased access to affordable, high-quality medicines. Allergan is an industry leader in research and development, with one of the broadest development pipelines in the pharmaceutical industry and a leading position in the submission of generic product applications globally.

With commercial operations in approximately 100 countries, Allergan is committed to working with physicians, healthcare providers and patients to deliver innovative and meaningful treatments that help people around the world live longer, healthier lives.

For more information, visit Allergan’s website at www.allergan.com.

About KYTHERA®
KYTHERA Biopharmaceuticals, Inc. is a biopharmaceutical company focused on the discovery, development and commercialization of novel prescription products for the aesthetic medicine market. In addition to its lead product KYBELLA™, KYTHERA also licensed the worldwide rights to setipiprant (KYTH-105), an early-stage potential treatment for hair loss. KYTHERA’s longer-term strategy is to leverage its biotechnology and aesthetics experience to expand its product portfolio and pipeline. KYTHERA has submitted regulatory filings for ATX-101 in Canada, Switzerland and Australia. Find more information at www.kythera.com.

NEW YORK & SUMMIT, N.J., – Bristol-Myers Squibb Company (NYSE:BMY) and Celgene Corporation (NASDAQ:CELG) today announced that they have entered into a definitive merger agreement under which Bristol-Myers Squibb will acquire Celgene in a cash and stock transaction with an equity value of approximately $74 billion. Under the terms of the agreement, Celgene shareholders will receive 1.0 Bristol-Myers Squibb share and $50.00 in cash for each share of Celgene. Celgene shareholders will also receive one tradeable Contingent Value Right (CVR) for each share of Celgene, which will entitle the holder to receive a payment for the achievement of future regulatory milestones. The Boards of Directors of both companies have approved the combination.

The transaction will create a leading focused specialty biopharma company well positioned to address the needs of patients with cancer, inflammatory and immunologic disease and cardiovascular disease through high-value innovative medicines and leading scientific capabilities. With complementary areas of focus, the combined company will operate with global reach and scale, maintaining the speed and agility that is core to each company’s strategic approach.

Based on the closing price of Bristol-Myers Squibb stock of $52.43 on January 2, 2019, the cash and stock consideration to be received by Celgene shareholders at closing is valued at $102.43 per Celgene share and one CVR (as described below). When completed, Bristol-Myers Squibb shareholders are expected to own approximately 69 percent of the company, and Celgene shareholders are expected to own approximately 31 percent.

“Together with Celgene, we are creating an innovative biopharma leader, with leading franchises and a deep and broad pipeline that will drive sustainable growth and deliver new options for patients across a range of serious diseases,” said Giovanni Caforio, M.D., Chairman and Chief Executive Officer of Bristol-Myers Squibb. “As a combined entity, we will enhance our leadership positions across our portfolio, including in cancer and immunology and inflammation. We will also benefit from an expanded early- and late-stage pipeline that includes six expected near-term product launches. Together, our pipeline holds significant promise for patients, allowing us to accelerate new options through a broader range of cutting-edge technologies and discovery platforms.”

Dr. Caforio continued, “We are impressed by what Celgene has accomplished for patients, and we look forward to welcoming Celgene employees to Bristol-Myers Squibb. Our new company will continue the strong patient focus that is core to both companies’ missions, creating a shared organization with a goal of discovering, developing and delivering innovative medicines for patients with serious diseases. We are confident we will drive value for shareholders and create opportunities for employees.”

“For more than 30 years, Celgene’s commitment to leading innovation has allowed us to deliver life-changing treatments to patients in areas of high unmet need. Combining with Bristol-Myers Squibb, we are delivering immediate and substantial value to Celgene shareholders and providing them meaningful participation in the long-term growth opportunities created by the combined company,” said Mark Alles, Chairman and Chief Executive Officer of Celgene. “Our employees should be incredibly proud of what we have accomplished together and excited for the opportunities ahead of us as we join with Bristol-Myers Squibb, where we can further advance our mission for patients. We look forward to working with the Bristol-Myers Squibb team as we bring our two companies together.”

Compelling Strategic Benefits
Leading franchises with complementary product portfolios provide enhanced scale and balance. The combination creates:
Leading oncology franchises in both solid tumors and hematologic malignancies led by Opdivo and Yervoy as well as Revlimid and Pomalyst;
A top five immunology and inflammation franchise led by Orencia and Otezla; and
The #1 cardiovascular franchise led by Eliquis.
The combined company will have nine products with more than $1 billion in annual sales and significant potential for growth in the core disease areas of oncology, immunology and inflammation and cardiovascular disease.

Near-term launch opportunities representing greater than $15 billion in revenue potential. The combined company will have six expected near-term product launches:
Two in immunology and inflammation, TYK2 and ozanimod; and
Four in hematology, luspatercept, liso-cel (JCAR017), bb2121 and fedratinib.
These launches leverage the combined commercial capabilities of the two companies and will broaden and enhance Bristol-Myers Squibb’s market position with innovative and differentiated products. This is in addition to a significant number of lifecycle management registrational readouts expected in Immuno-Oncology (IO).

Early-stage pipeline builds sustainable platform for growth. The combined company will have a deep and diverse early-stage pipeline across solid tumors and hematologic malignancies, immunology and inflammation, cardiovascular disease and fibrotic disease leveraging combined strengths in innovation. The early-stage pipeline includes 50 high potential assets, many with important data readouts in the near-term. With a significantly enhanced early-stage pipeline, Bristol-Myers Squibb will be well positioned for long-term growth and significant value creation.
Powerful combined discovery capabilities with world-class expertise in a broad range of modalities. Together, the Company will have expanded innovation capabilities in small molecule design, biologics/synthetic biologics, protein homeostasis, antibody engineering and cell therapy. Furthermore, strong external partnerships provide access to additional modalities.
Compelling Financial Benefits

Strong returns and significant immediate EPS accretion. The transaction’s internal rate of return is expected to be well in excess of Celgene’s and Bristol-Myers Squibb’s cost of capital. The combination is expected to be more than 40 percent accretive to Bristol-Myers Squibb’s EPS on a standalone basis in the first full year following close of the transaction.
Strong balance sheet and cash flow generation to enable significant investment in innovation. With more than $45 billion of expected free cash flow generation over the first three full years post-closing, the Company is committed to maintaining strong investment grade credit ratings while continuing its dividend policy for the benefit of Bristol-Myers Squibb and Celgene shareholders. Bristol-Myers Squibb will also have significant financial flexibility to realize the full potential of the enhanced late- and early-stage pipeline.
Meaningful cost synergies. Bristol-Myers Squibb expects to realize run-rate cost synergies of approximately $2.5 billion by 2022. Bristol-Myers Squibb is confident it will achieve efficiencies across the organization while maintaining a strong, core commitment to innovation and delivering the value of the portfolio.
Terms and Financing

Based on the closing price of Bristol-Myers Squibb stock on January 2, 2019, the cash and stock consideration to be received by Celgene shareholders is valued at $102.43 per share. The cash and stock consideration represents an approximately 51 percent premium to Celgene shareholders based on the 30-day volume weighted average closing stock price of Celgene prior to signing and an approximately 54 percent premium to Celgene shareholders based on the closing stock price of Celgene on January 2, 2019. Each share also will receive one tradeable CVR, which will entitle its holder to receive a one-time potential payment of $9.00 in cash upon FDA approval of all three of ozanimod (by December 31, 2020), liso-cel (JCAR017) (by December 31, 2020) and bb2121 (by March 31, 2021), in each case for a specified indication.

The transaction is not subject to a financing condition. The cash portion will be funded through a combination of cash on hand and debt financing. Bristol-Myers Squibb has obtained fully committed debt financing from Morgan Stanley Senior Funding, Inc. and MUFG Bank, Ltd. Following the close of the transaction, Bristol-Myers Squibb expects that substantially all of the debt of the combined company will be pari passu.

Accelerated Share Repurchase Program
Bristol-Myers Squibb expects to execute an accelerated share repurchase program of up to approximately $5 billion, subject to the closing of the transaction, market conditions and Board approval.

Corporate Governance
Following the close of the transaction, Dr. Caforio will continue to serve as Chairman of the Board and Chief Executive Officer of the company. Two members from Celgene’s Board will be added to the Board of Directors of Bristol-Myers Squibb. The combined company will continue to have a strong presence throughout New Jersey.

Approvals and Timing to Close
The transaction is subject to approval by Bristol-Myers Squibb and Celgene shareholders and the satisfaction of customary closing conditions and regulatory approvals. Bristol-Myers Squibb and Celgene expect to complete the transaction in the third quarter of 2019.

Advisors
Morgan Stanley & Co. LLC is serving as lead financial advisor to Bristol-Myers Squibb, and Evercore and Dyal Co. LLC are serving as financial advisors to Bristol-Myers Squibb. Kirkland & Ellis LLP is serving as Bristol-Myers Squibb’s legal counsel. J.P. Morgan Securities LLC is serving as lead financial advisor and Citi is acting as financial advisor to Celgene. Wachtell, Lipton, Rosen & Katz is serving as legal counsel to Celgene.

About Bristol-Myers Squibb
Bristol-Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. For more information about Bristol-Myers Squibb, visit us at BMS.com or follow us on LinkedIn, Twitter, YouTube and Facebook.

About Celgene
Celgene Corporation, headquartered in Summit, New Jersey, is an integrated global biopharmaceutical company engaged primarily in the discovery, development and commercialization of innovative therapies for the treatment of cancer and inflammatory diseases through next-generation solutions in protein homeostasis, immuno-oncology, epigenetics, immunology and neuro-inflammation. For more information, please visit www.celgene.com. Follow Celgene on Social Media: @Celgene, Pinterest, LinkedIn, Facebook and YouTube

In October, 2015, 22 scientists from ten countries met at the International Agency for Research on Cancer (IARC) in Lyon, France, to evaluate the carcinogenicity of the consumption of red meat and processed meat.

Red meat refers to unprocessed mammalian muscle meat—for example, beef, veal, pork, lamb, mutton, horse, or goat meat—including minced or frozen meat; it is usually consumed cooked. Processed meat refers to meat that has been transformed through salting, curing, fermentation, smoking, or other processes to enhance flavour or improve preservation. Most processed meats contain pork or beef, but might also contain other red meats, poultry, offal (eg, liver), or meat byproducts such as blood.

Red meat contains high biological-value proteins and important micronutrients such as B vitamins, iron (both free iron and haem iron), and zinc. The fat content of red meat varies depending on animal species, age, sex, breed, and feed, and the cut of the meat. Meat processing, such as curing and smoking, can result in formation of carcinogenic chemicals, including N-nitroso-compounds (NOC) and polycyclic aromatic hydrocarbons (PAH). Cooking improves the digestibility and palatability of meat, but can also produce known or suspected carcinogens, including heterocyclic aromatic amines (HAA) and PAH. High-temperature cooking by pan-frying, grilling, or barbecuing generally produces the highest amounts of these chemicals.

Depending on the country, the proportion of the population that consumes red meat varies worldwide from less than 5% to up to 100%, and from less than 2% to 65% for processed meat. The mean intake of red meat by those who consume it is about 50–100 g per person per day, with high consumption equalling more than 200 g per person per day.4 Less information is available on the consumption of processed meat.

The Working Group assessed more than 800 epidemiological studies that investigated the association of cancer with consumption of red meat or processed meat in many countries, from several continents, with diverse ethnicities and diets. For the evaluation, the greatest weight was given to prospective cohort studies done in the general population. High quality population-based case-control studies provided additional evidence. For both designs, the studies judged to be most informative were those that considered red meat and processed meat separately, had quantitative dietary data obtained from validated questionnaires, a large sample size, and controlled for the major potential confounders for the cancer sites concerned.

The largest body of epidemiological data concerned colorectal cancer. Data on the association of red meat consumption with colorectal cancer were available from 14 cohort studies. Positive associations were seen with high versus low consumption of red meat in half of those studies, including a cohort from ten European countries spanning a wide range of meat consumption and other large cohorts in Sweden and Australia.5, 6, 7 Of the 15 informative case-control studies considered, seven reported positive associations of colorectal cancer with high versus low consumption of red meat. Positive associations of colorectal cancer with consumption of processed meat were reported in 12 of the 18 cohort studies that provided relevant data, including studies in Europe, Japan, and the USA.5, 8, 9, 10, 11 Supporting evidence came from six of nine informative case-control studies. A meta-analysis of colorectal cancer in ten cohort studies reported a statistically significant dose–response relationship, with a 17% increased risk (95% CI 1·05–1·31) per 100 g per day of red meat and an 18% increase (95% CI 1·10–1·28) per 50 g per day of processed meat.12
Data were also available for more than 15 other types of cancer. Positive associations were seen in cohort studies and population-based case-control studies between consumption of red meat and cancers of the pancreas and the prostate (mainly advanced prostate cancer), and between consumption of processed meat and cancer of the stomach.

On the basis of the large amount of data and the consistent associations of colorectal cancer with consumption of processed meat across studies in different populations, which make chance, bias, and confounding unlikely as explanations, a majority of the Working Group concluded that there is sufficient evidence in human beings for the carcinogenicity of the consumption of processed meat. Chance, bias, and confounding could not be ruled out with the same degree of confidence for the data on red meat consumption, since no clear association was seen in several of the high quality studies and residual confounding from other diet and lifestyle risk is difficult to exclude. The Working Group concluded that there is limited evidence in human beings for the carcinogenicity of the consumption of red meat.

There is inadequate evidence in experimental animals for the carcinogenicity of consumption of red meat and of processed meat. In rats treated with colon cancer initiators and promoted with low calcium diets containing either red meat or processed meat, an increase in the occurrence of colonic preneoplastic lesions was reported in three and four studies, respectively.13, 14, 15

The mechanistic evidence for carcinogenicity was assessed as strong for red meat and moderate for processed meat. Mechanistic evidence is mainly available for the digestive tract. A meta-analysis published in 2013 reported a modest but statistically significant association between consumption of red or processed meat and adenomas (preneoplastic lesions) of the colorectum that was consistent across studies.16 For genotoxicity and oxidative stress, evidence was moderate for the consumption of red or processed meat. In human beings, observational data showed slight but statistically significant associations with APC gene mutation or promoter methylation that were identified in 75 (43%) and 41 (23%) of 185 archival colorectal cancer samples, respectively.17 Consuming well done cooked red meat increases the bacterial mutagenicity of human urine. In three intervention studies in human beings, changes in oxidative stress markers (either in urine, faeces, or blood) were associated with consumption of red meat or processed meat.18 Red and processed meat intake increased lipid oxidation products in rodent faeces.13
Substantial supporting mechanistic evidence was available for multiple meat components (NOC, haem iron, and HAA). Consumption of red meat and processed meat by man induces NOC formation in the colon. High red meat consumption (300 or 420 g/day) increased levels of DNA adducts putatively derived from NOC in exfoliated colonocytes or rectal biopsies in two intervention studies.19, 20 Few human data, especially from intervention studies, were available for processed meat. Haem iron mediates formation of NOC, and of lipid oxidation products in the digestive tract of human beings and rodents. Haem iron effects can be experimentally suppressed by calcium, supporting its contribution to carcinogenic mechanisms. Meat heated at a high temperature contains HAA. HAA are genotoxic, and the extent of conversion of HAA to genotoxic metabolites is greater in man than in rodents. Meat smoked or cooked over a heated surface or open flame contains PAH. These chemicals cause DNA damage, but little direct evidence exists that this occurs following meat consumption.

Overall, the Working Group classified consumption of processed meat as “carcinogenic to humans” (Group 1) on the basis of sufficient evidence for colorectal cancer. Additionally, a positive association with the consumption of processed meat was found for stomach cancer.

The Working Group classified consumption of red meat as “probably carcinogenic to humans” (Group 2A). In making this evaluation, the Working Group took into consideration all the relevant data, including the substantial epidemiological data showing a positive association between consumption of red meat and colorectal cancer and the strong mechanistic evidence. Consumption of red meat was also positively associated with pancreatic and with prostate cancer.

DUBLIN, Ohio, March 15, 2024 — Cardinal Health (NYSE: CAH) today announced that the company has received approval by the Science Based Targets initiative (SBTi) for its near-term science-based greenhouse gas (GHG) emissions reduction targets. Targets are considered science-based if they align with what the latest climate science says is necessary to limit global warming to 1.5°C above pre-industrial levels.

“We are committed to reducing our impact on the environment and contributing to a more sustainable world,” said Megan Maltenfort, Cardinal Health’s VP of Environmental, Social and Governance (ESG). “We value our work with SBTi and will continue taking proactive steps to address climate change and to reduce the environmental impact of our products and processes.”

With the SBTi approval, Cardinal Health commits to the following science-based targets:

reduce absolute Scope 1 and 2 GHG emissions 50% by fiscal 2030 from a fiscal 2019 base year.*
75% of its suppliers by spend, covering purchased goods and services and upstream transportation and distribution, will have science-based targets by fiscal 2028.
These approved targets represent an expansion of the company’s current goal of reducing Scope 1 and 2 GHG emissions, announced in September 2021; the inclusion of Scope 3 emissions from our supply chain has made the goal more ambitious.

“As we work to achieve our targets, we will collaborate with partners along our supply chain to collectively address the impacts of climate change,” Maltenfort said.

By the end of fiscal 2023, Cardinal Health had reduced its Scope 1 and 2 emissions by 13% from a fiscal 2019 base year. In addition, the company continues to invest in energy efficiency opportunities in its distribution and manufacturing sites and is looking to expand its use of renewable energy across the enterprise. Cardinal Health reports on progress toward its climate goals in its annual Environmental, Social and Governance (ESG) Report.

The Science Based Targets initiative (SBTi) is a global body enabling businesses to set ambitious emissions reductions targets in line with the latest climate science. It is a collaboration between CDP, the United Nations Global Compact, World Resources Institute (WRI) and the World Wide Fund for Nature (WWF) and one of the We Mean Business Coalition commitments.

*The target boundary includes land-related emissions and removals from bioenergy feedstocks.

About Cardinal Health
Cardinal Health is a distributor of pharmaceuticals, a global manufacturer and distributor of medical and laboratory products, and a provider of performance and data solutions for healthcare facilities. With more than 50 years in business, operations in more than 30 countries and approximately 48,000 employees globally, Cardinal Health is essential to care. Information about Cardinal Health is available at cardinalhealth.com.

DUBLIN, Ohio, Jan. 9, 2024 — Cardinal Health (NYSE:CAH) today announced progress on the company’s ongoing business and portfolio review, including an updated enterprise operating and segment reporting structure, and an update to its fiscal year 2024 non-GAAP diluted earnings per share (EPS) outlook. These updates build upon the company’s momentum, focus on long-term value creation, and continued actions to become more streamlined and focused. The company will host an analyst conference call today beginning at 8:30 a.m. E.T. where management will further discuss these announcements.

“We are excited to demonstrate further progress on how we are driving our company, and healthcare, forward,” said Jason Hollar CEO of Cardinal Health. “As we continue down the path of becoming a simplified and more focused company, these actions align with our operational focus on the core of our business, provide increased visibility to key growth areas, and enable greater efficiencies across all our businesses. We continue to prioritize focused execution to best serve our customers and advance our mission as healthcare’s most trusted partner.”

Business and portfolio review update

While Cardinal Health’s business and portfolio review efforts remain active and ongoing, the company has completed a review of its growth businesses within the Medical Segment, at-Home Solutions and OptiFreight® Logistics, and has determined that investing in and further developing these businesses will drive the most significant long-term shareholder value creation for Cardinal Health. This conclusion follows the June 2023 announcement that the business review determined that Cardinal Health would retain and invest in its attractive Nuclear and Precision Health Solutions business.

Cardinal Health’s at-Home Solutions business, a $2.6B revenue leading home healthcare medical supplies provider serving people with chronic and serious health conditions in the United States, is well-positioned to continue to accelerate in the coming years with industry trends of care shifting to the home. To support increased demand, the company is investing in network expansion, and today, is announcing plans to build a new distribution center in Texas, with increased capacity, advanced automation and robotics within the facility. This is in addition to the recently opened site in Ohio, and the previously announced expansion in South Carolina set to open this calendar year.

Cardinal Health’s OptiFreight® Logistics, a $250M revenue leading provider of healthcare logistics, manages over 21 million shipments annually to 22,000 healthcare provider shipping locations across the continuum of care. Powered by its proprietary technology and team’s deep expertise, the business has a strong operational track record of profitable growth over many years. To sustain the business’ strong performance, the company continues to invest in innovative and technology-driven solutions such as TotalVue™ Insights that enable healthcare supply chain leaders to optimize their transportation and logistics processes and control shipping spend.

Cardinal Health’s review of its Global Medical Products and Distribution business continues, with a focus on executing the Medical Improvement Plan, which remains a critical priority for the enterprise. The company is continuing to drive ongoing initiatives and invest in the business to support customers’ needs and achieve its long-term target.

Operating and segment reporting structure update

The company also announced plans to realign its business to increase its focus on the core and accelerate its growth areas.

Effective January 1, 2024, the company began operating under an updated enterprise operating and segment reporting structure, which includes two reportable segments Pharmaceutical and Specialty Solutions and Global Medical Products and Distribution (GMPD). Separate from these two segments, Nuclear and Precision Health Solutions, at-Home Solutions and OptiFreight® Logistics will be reported as Other1.

The Pharmaceutical and Specialty Solutions Segment, previously in the Pharmaceutical Segment, continues under the leadership of Debbie Weitzman. The segment consists of the company’s largest and most significant businesses, its resilient Pharmaceutical Distribution business and its higher-growth Specialty business, including both downstream Specialty Distribution and upstream Manufacturer Services. Weitzman will continue to report directly to Jason Hollar.

The GMPD segment, previously in the Medical Segment, continues to be led by Steve Mason. The segment consists of the company’s U.S. and International Products and Distribution businesses, as well as its WaveMark business. Mason will report directly to Jason Hollar and continue to have a pivotal role in driving the success of the Medical Improvement Plan.

Other consists of at-Home Solutions and OptiFreight® Logistics from the former Medical Segment, and Nuclear and Precision Health Solutions from the former Pharmaceutical Segment. Each of these businesses will continue to operate independently and each of the business leaders, Rob Schlissberg, at-Home Solutions; Emily Gallo, OptiFreight® Logistics; and Mike Pintek, Nuclear and Precision Health Solutions, will now report directly to Jason Hollar. This updated operating structure is designed to provide greater visibility to the performance of these businesses and allow prioritization of investments to ensure their long-term success.

The company plans to report its second quarter fiscal 2024 results on February 1, 2024, according to its former reporting segments and will then report its third quarter fiscal 2024 results and forward on the basis of its updated structure.

Fiscal 24 outlook update

The company updated fiscal year 2024 non-GAAP diluted EPS guidance to the high end of its $6.75 to $7.00 range.

This update is driven by anticipated favorability in fiscal 24 Interest and Other and Diluted Weighted Average Shares Outstanding, due to continued strong cash flow generation, resulting in higher-than-expected cash balances, and the execution of a new $250M accelerated share repurchase program in the second quarter.

The company also provided an update to its previous expectations for second quarter Medical segment profit. While utilization trends, including Cardinal Health™ Brand volumes, and inflation mitigation efforts have trended according to the company’s expectations in the GMPD business, the company now anticipates second quarter Medical segment profit to be generally consistent with first quarter Medical segment profit, due to anticipated non-recurring adjustments in the second quarter. These anticipated non-recurring adjustments do not affect the company’s progression towards its previously-communicated fiscal 26 targets.

The company will provide further updates and details on its fiscal second quarter results and its fiscal 24 guidance during its second quarter earnings call, on February 1, 2024.

Long-term financial targets

The company reiterated its long-term financial targets reflecting 12% to 14% growth of non-GAAP diluted EPS2.

The company also provided pro-forma long-term targets for its updated segment reporting structure, and, for information purposes, recast its fiscal 2023 actuals on the same basis3.

The company’s previously announced Medical Improvement Plan targeting at least $650M of segment profit by fiscal 26 continues, with elements of that plan to reside in the results of both GMPD and Other.

FY23 Actuals3

Long-term Target

Businesses

Pharmaceutical and
Specialty Solutions

Revenue:

~$188.8B

Segment Profit:

~1.87B

4-6%

Segment Profit CAGR2

Former Pharmaceutical Segment, excluding Nuclear
and Precision Health Solutions

GMPD

Revenue:

~$12.1B

Segment Profit:

~$(165)M

~$300 million

in Segment Profit by FY26

Former Medical Segment, excluding at-Home Solutions
and OptiFreight® Logistics

Other

Revenue:

~$4.1B

Segment Profit:

~$410M

8-10%

Segment Profit CAGR2

at-Home Solutions, Nuclear and Precision Health Solutions
and OptiFreight® Logistics

The company does not provide forward-looking guidance on a GAAP basis as certain financial information, the probable significance of which cannot be determined, is not available and cannot be reasonably estimated. See “Forward-Looking Non-GAAP Measures” below for additional explanation.

Analyst Conference Call and Webcasted Investor Events

The company will hold an analyst conference call, which will be webcast, to discuss today’s announcements prior to the opening of trading on the New York Stock Exchange beginning at 8:30 a.m. Eastern.

Additionally, the company plans to present at the 42nd Annual J.P. Morgan Healthcare Conference today beginning at 5:15 p.m. Eastern.

To access the webcasts and corresponding presentations, visit Cardinal Health’s Investor Relations page. No access code is required. Presentation slides and a webcast replay will be available on the Investor Relations page for 12 months.

About Cardinal Health

Cardinal Health is a distributor of pharmaceuticals, a global manufacturer and distributor of medical and laboratory products, and a provider of performance and data solutions for healthcare facilities. With more than 50 years in business, operations in more than 30 countries and approximately 48,000 employees globally, Cardinal Health is essential to care. Information about Cardinal Health is available at cardinalhealth.com.

Contacts

Media: Erich Timmerman, erich.timmerman@cardinalhealth.com and 614.757.8231

Investors: Matt Sims, matt.sims@cardinalhealth.com and 614.553.3661

1 Other includes the following three operating segments: at-Home Solutions, Nuclear and Precision Health Solutions and OptiFreight® Logistics, which are not significant enough individually to require reportable segment disclosure.
2 FY24 to FY26 CAGR, as of FY23 baseline.
3 Recast FY23 actuals for updated segment reporting structure are considered preliminary and pending a final recast of segment results that is expected to be completed by the company’s Q3 FY24 earnings release. The sum of the components may reflect rounding adjustments.

Cautions Concerning Forward-Looking Statements

This news release contains forward-looking statements addressing expectations, prospects, estimates and other matters that are dependent upon future events or developments. These statements may be identified by words such as “expect,” “anticipate,” “intend,” “plan,” “believe,” “will,” “should,” “could,” “would,” “project,” “continue,” “likely,” and similar expressions, and include statements reflecting future results or guidance, statements of outlook, preliminary recast fiscal 2023 results and various accruals and estimates. These matters are subject to risks and uncertainties that could cause actual results to differ materially from those projected, anticipated or implied. These risks and uncertainties include risks arising from ongoing inflationary pressures, including the risk that our plans to mitigate such effects may not be as successful as we anticipate or that costs could remain elevated; the possibility that our Medical unit goodwill could be further impaired due to additional changes to our long-term financial plan, increases in global interest rates or unfavorable changes in the U.S. statutory tax rate; risks associated with our ongoing review of our operations, portfolio and businesses, including the risk that our management team could become distracted or that the outcome of such review may have unintended consequences; competitive pressures in Cardinal Health’s various lines of business, including the risk that customers may reduce purchases made under their contracts with us or terminate or not renew their contracts; the performance of our generics program, including the amount or rate of generic deflation and our ability to offset generic deflation and maintain other financial and strategic benefits through our generic sourcing venture or other components of our generics programs; ongoing risks associated with the distribution of opioids, including the financial impact associated with the settlements with governmental authorities and the risk that challenges to tax deductions for opioid-related losses could adversely impact our financial results; risks arising from the Department of Justice investigation which we believe concerns our anti-diversion program and risks associated with the injunctive relief requirements under the national settlement, including the risk that we may incur higher costs or operational challenges in the implementation and maintenance of the required changes; risks associated with the manufacture and sourcing of certain products, including risks related to our ability and the ability of third-party manufacturers to import or export certain products or component parts and to comply with applicable regulations; our ability to manage uncertainties associated with the pricing of branded pharmaceuticals; uncertainties related to the timing, magnitude and profit impact of the distribution of recently commercially available COVID-19 vaccines; risks associated with business process initiatives, such as the Medical Improvement Plan, including the possibility that they could fail to achieve the intended results; and the risk that we may not realize the anticipated benefits related to our updated operating and segment reporting structure. Cardinal Health is subject to additional risks and uncertainties described in Cardinal Health’s Form 10-K, Form 10-Q and Form 8-K reports and exhibits to those reports. This news release reflects management’s views as of January 9, 2024. Except to the extent required by applicable law, Cardinal Health undertakes no obligation to update or revise any forward-looking statement. Forward-looking statements are aspirational and not guarantees or promises that goals, targets or projections will be met, and no assurance can be given that any commitment, expectation, initiative or plan in this news release can or will be achieved or completed.

Forward Looking Non-GAAP Measures

In this news release, the company presents certain forward-looking non-GAAP metrics. The company does not provide outlook on a GAAP basis because the items that the company excludes from GAAP to calculate the comparable non-GAAP measure can be dependent on future events that are less capable of being controlled or reliably predicted by management and are not part of the company’s routine operating activities. Additionally, management does not forecast many of the excluded items for internal use and therefore cannot create or rely on outlook done on a GAAP basis.

The occurrence, timing and amount of any of the items excluded from GAAP to calculate non-GAAP could significantly impact the company’s fiscal 2024 GAAP results. Over the past five fiscal years, the excluded items have impacted the company’s EPS from $0.75 to $18.06, which includes a $17.54 charge related to the opioid litigation the company recognized in fiscal 2020.

Definitions

Non-GAAP net earnings attributable to Cardinal Health, Inc.: net earnings attributable to Cardinal Health, Inc. excluding (1) LIFO charges/(credits), (2) state opioid assessment related to prior fiscal years, (3) shareholder cooperation agreement costs, (4) restructuring and employee severance, (5) amortization and other acquisition-related costs, (6) impairments and (gain)/loss on disposal of assets, net, (7) litigation (recoveries)/charges, net and (8) loss on early extinguishment of debt.

Non-GAAP diluted earnings per share attributable to Cardinal Health, Inc.: non-GAAP net earnings attributable to Cardinal Health, Inc. divided by diluted weighted-average shares outstanding.

SOURCE Cardinal Health, Inc.

DUBLIN, Ohio, Feb. 29, 2024 — Today, Cardinal Health (NYSE: CAH) released its 2024 Biosimilars Report: insights on a pivotal year of evolution and expansion, an analysis of key recent economic, competitive, legislative and societal developments in biosimilars. The publication highlights legislative developments and new treatments, including adalimumab biosimilars. The report also provides the perspectives of retina specialists on biosimilars, ahead of the expected launch of multiple new biosimilars for retinal diseases.

“It is more important than ever that all stakeholders of the healthcare ecosystem understand the significant benefits biosimilars offer to patients, providers, practices and payers alike,” said Fran Gregory, PharmD, MBA, VP, Cardinal Health Emerging Therapies. “The savings generated by biosimilars will play an increasingly important part in creating a balance between funding innovative new treatments and reducing the overall financial burden on the healthcare system. This report offers critical context on this rapidly changing clinical and market landscape, and the role biosimilars will play in increasing the accessibility and affordability of care.”

The report examines a year of major developments in biosimilars, offering expert commentary and provider perspectives on a rapidly changing industry landscape. Featuring new research derived from surveys and expert interviews, the report offers new insights into market growth, drivers of biosimilar adoption and remaining barriers to widespread uptake.

With 2024 expected to be a critical year for retina biosimilars, Cardinal Health surveyed providers in ophthalmology to obtain perspectives that may influence adoption while highlighting continued obstacles to wider use of biosimilars. Nearly 80% of survey participants said they are “extremely” or “very” familiar with biosimilars, though fewer than 60% have prescribed a biosimilar for the treatment of a retinal disorder. 82% of retina specialists said they would be “very” or “somewhat” more likely to prescribe biosimilars if they became a payer’s preferred drug. Notably, the research also suggests widespread belief in biosimilars’ potential impact on healthcare system sustainability, with 75% of participants agreeing that biosimilars can improve healthcare system sustainability.

In addition to this new research, the report also includes in-depth analysis of:

The evolving payer landscape
Emerging best practices for managing biosimilar inventory
How biosimilars are promoting access and healthcare system sustainability
The biosimilars product pipeline
The report can be accessed at www.cardinalhealth.com/biosimilarsreport

About Cardinal Health
Cardinal Health is a distributor of pharmaceuticals, a global manufacturer and distributor of medical and laboratory products, and a provider of performance and data solutions for healthcare facilities. With more than 50 years in business, operations in more than 30 countries and approximately 48,000 employees globally, Cardinal Health is essential to care. Information about Cardinal Health is available at cardinalhealth.com.

Media contact: Tori Simmons, Victoria.Simmons@cardinalhealth.com

DUBLIN, Ohio — Cardinal Health (NYSE: CAH) announced today its plans to build a new distribution center in the Greenville, South Carolina, area, to support its at-Home Solutions business, a market-leading home healthcare medical supplies provider serving people with chronic and serious health conditions in the United States.

At approximately 350,000 square feet, the new building will provide at-Home Solutions with the space and automation it needs to serve its existing customers and patients while allowing for business expansion.

“I am thrilled about this new space, which is the second building we’ve built from the ground up inside of two years – and the largest building at-Home Solutions has ever opened to date,” said Rob Schlissberg, president, at-Home Solutions. “This announcement is a testament to the growth that we’re seeing as a business and across the industry. Over a little more than a decade, we’ve grown from serving about 1 million customers annually to more than 4 million – and with that growth, we need more space to meet customer demands efficiently and quickly.”

The new facility is at-Home Solutions 11th distribution center nationwide, estimated to bring up to 200 job opportunities to the Greenville region over the next two years.

While the distribution center has the capability to support all 50 states, its primary focus will be customers located in the Carolinas, Virginia, Georgia, Alabama, Tennessee, Missouri and Louisiana. Once operational, it will ship approximately 8,000 packages per day directly to patient homes. The business currently ships approximately 55,000 packages per day from its 10 sites.

Advanced automation and robotics enhance new facility
Advanced automation technology and robotics within the facility, including outbound conveyor automation and state-of-the-art warehouse management systems, will further increase inventory capacity and improve service levels for the business so the right products can be at the right place at the right time.

This will be the second Cardinal Health distribution center to feature AutoStore empowered by Swisslog, the fastest order fulfillment system per square foot in the market.

The AutoStore solution, optimized by Swisslog’s SynQ software, employs autonomous robots that move on top of an aluminum cubic grid to continuously pick up, rearrange and deliver storage bins from the grid directly to connected workstations for order picking and replenishment. The solution combines robotics with artificial intelligence to optimize inventory storage space and accuracy, increase employee productivity and drive efficiencies within daily movement of product. Specific to the new Greenville distribution center, it will provide more than 290,000 cubic feet of storage for over 13,000 SKUs with 76 robots, eight picking stations and three replenishment stations supporting nearly 70,000 bin storage locations.

Additionally, the facility will feature two of the world’s first fully automated erected box systems, called the Packsize X5®. Each system produces 600 ready-to-pack, right-sized erected boxes per hour, bringing more speed to order fulfillment.

“These technologies provide us with better inventory accuracy, improve the quality in which we pick, pack and ship orders, and enhance employee safety and experience within the warehouse. They also attract a uniquely skilled workforce that will augment our operations, which is absolutely critical to our success as a business,” said Mike DeSimpelaere, vice president of network operations, at-Home Solutions.

Construction on the new facility will begin this summer; it’s estimated to be fully operational within 18 to 24 months. Stay updated on career opportunities at the site at cardinalhealth.com/careers.

About Cardinal Health
Cardinal Health is a distributor of pharmaceuticals, a global manufacturer and distributor of medical and laboratory products, and a provider of performance and data solutions for health care facilities. With 50 years in business, operations in more than 30 countries and approximately 46,500 employees globally, Cardinal Health is essential to care. Information about Cardinal Health is available at cardinalhealth.com.

Contacts
Media: Cari Wildasinn, cari.wildasinn@cardinalhealth.com and 614.757.8287

SOURCE Cardinal Health

Ten experts from the Centers for Disease Control and Prevention – supported 24/7 by the CDC’s full Emergency Operations Center and Ebola experts in CDC’s Atlanta headquarters – have arrived in Texas and are working closely with Texas state and local health departments to investigate the first Ebola case in the United States. Nine members of the CDC team arrived last night and one arrived today.

The CDC team consists of:
Three senior scientists with expertise in public health investigations and infection control
A communications officer
Five Epidemic Intelligence Service (EIS) officers – CDC’s disease detectives
A public health advisor

These CDC experts will assist state and local health departments find, assess, and assist everyone who came into contact with the Ebola patient between the time he became symptomatic (before having symptoms, people with Ebola cannot spread the infection) and the time he was placed in an isolation ward. The CDC experts will help ensure that proper infection control procedures are followed, and monitor healthcare workers treating or attending to the patient. Long experience shows that these tried-and-true core public health interventions stop the spread of Ebola
“We are stopping Ebola in its tracks in this country,” said CDC Director Tom Frieden, M.D., M.P.H. “We can do that because of two things: strong infection control that stops the spread of Ebola in health care; and strong core public health functions to trace contacts, track contacts, isolate them if they have any symptoms and stop the chain of transmission. I am certain we will control this.”

The CDC team now is:
Making sure the patient is receiving treatment and is isolated;
Interviewing the patient and close contacts, such as family members, to obtain detailed information on their travel history and exposures;
Ensuring the hospital uses appropriate infection control measures;
Identifying people who had close contact with the patient and
interviewing them,
monitoring them to see if they become ill,
collecting and testing specimens from them, if needed, and
requesting that they monitor their health and seek care if they develop symptoms; and
Monitoring the health status of healthcare providers who cared for the patient
Any hospital following strict CDC infection control recommendations and that can isolate a patient in their own room with a private bathroom is capable of safely managing a patient with Ebola.

“We recognize that it is essential that appropriate measures are taken to prevent the virus from spreading,” Dr. Frieden said. “CDC is working closely with partners to implement those measures.”

Travelers from Guinea, Liberia, Nigeria, or Sierra Leone should monitor their health for symptoms, fever greater than 101.5 degrees Fahrenheit, severe headache, muscle pain, diarrhea, vomiting, stomach pain, or unexplained bruising or bleeding, for 21 days after travel. They should see a healthcare provider as soon as any of these symptoms develop, letting them know of their travel history and symptoms.

CDC is issuing a general reminder to travelers and healthcare providers on best practices. Healthcare providers should take a travel history from any person with symptoms of viral infection. They should consider Ebola in patients who develop fever greater than 101.5 degrees Fahrenheit, severe headache, muscle pain, diarrhea, vomiting, stomach pain, or unexplained bruising or bleeding 21 days after traveling from Guinea, Liberia, Nigeria, or Sierra Leone. They should immediately take infection control precautions and contact their state or local health department if they have any questions.

CDC and the state of Texas will post new information about Ebola on their websites:
CDC website: www.cdc.gov/vhf/ebola
Travelers’ Health: http://wwwnc.cdc.gov/travel/notices/
Texas Department of State Health Services website: https://www.dshs.state.tx.us/default.shtmExternal Web Site Icon
CDC is part of a whole-government approach to protecting the American public from Ebola and ending the Ebola epidemic in West Africa.

BEIJING, May 21, 2021 — China on Friday announced several new measures to help developing countries tackle the COVID-19 pandemic and its sweeping impacts, pledging to contribute $3 billion in the next three years and provide more vaccines.

Addressing the Global Health Summit via video link, Chinese President Xi Jinping urged the world’s leading economies to remedy deficiencies, close loopholes and strengthen weak links in fighting “the most serious pandemic in a century.”

CGTN：China makes new pledges to help developing countries defeat COVID-19
CGTN：China makes new pledges to help developing countries defeat COVID-19
The summit was co-hosted by the European Commission and Italy, chair of the Group of 20 (G20) this year.

The number of confirmed COVID-19 cases worldwide has surpassed 165 million, with more than 3.4 million deaths, according to data from Johns Hopkins University.

‘Close the immunization gap’

“A year ago, I proposed that vaccines should be made a global public good,” Xi said. “Today, the problem of uneven vaccination has become more acute.”

More than 1.1 billion COVID-19 vaccine doses have been administered globally, but over 80 percent of those were administered in high and upper-middle income countries, with just 0.3 percent of inoculations taking place in low-income countries, Dr. Tedros Adhanom Ghebreyesus, director general of the World Health Organization (WHO), said earlier this month.

China has supplied 300 million doses of vaccines to the world; it has provided free vaccines to more than 80 developing countries in urgent need and exported vaccines to 43 countries, Xi noted, adding that China will provide more vaccines to the best of its ability.

China supports its vaccine companies in transferring technologies to other developing countries and carrying out joint production with them, he said.

Reaffirming China’s support for waiving intellectual property rights on COVID-19 vaccines, he said the country “supports the World Trade Organization and other international institutions in making an early decision on this matter.”

He raised a proposal for setting up an international forum on vaccine cooperation to promote fair and equitable distribution of vaccines around the world.

“We must uphold fairness and equity as we strive to close the immunization gap,” Xi stressed. “It is imperative for us to reject vaccine nationalism and find solutions to issues concerning the production capacity and distribution of vaccines, in order to make vaccines more accessible and affordable in developing countries.”

More financial support

China has already provided $2 billion to help with developing countries’ responses to COVID-19; it has sent medical supplies to more than 150 countries and 13 international organizations, providing more than 280 billion masks, 3.4 billion protective suits and four billion testing kits to the world, according to Xi.

“China will provide an additional $3 billion in international aid over the next three years to support COVID-19 response and economic and social recovery in other developing countries,” he announced.

Xi, the leader of the world’s largest developing country, mentioned “developing countries” 11 times in a speech that lasted less than seven minutes, calling on G20 members to do more to help them and address their concerns.

“China is fully implementing the G20 Debt Service Suspension Initiative for Poorest Countries and has so far put off debt repayment exceeding $1.3 billion, the highest deferral amount among G20 members,” he said.

It is essential that G20 members continue to support developing countries by such means as debt suspension and development aid, said the Chinese president.

Xi went further to call for improvement in the global governance system. G20 countries should strengthen and leverage the role of the United Nations and the WHO and improve the global disease prevention and control system, the Chinese president said.

“It is important that we uphold the spirit of extensive consultation, joint contribution and shared benefits, fully heed the views of developing countries, and better reflect their legitimate concerns,” he added.

Xi repeated his call for solidarity and cooperation in fighting COVID-19 and building a global community of health for all.

“The pandemic is yet another reminder that we, humanity, rise and fall together with a shared future,” he said. “We must champion the vision of building a global community of health for all, tide over this trying time through solidarity and cooperation, and firmly reject any attempt to politicize, label or stigmatize the virus.”

https://news.cgtn.com/news/2021-05-21/China-makes-new-pledges-to-help-developing-countries-defeat-COVID-19-10rWrYN7HGg/index.html

SOURCE CGTN

CONTACT: Media Contact: Jiang Simin, +86-188-2655-3286, cgtn@cgtn.com

Related Links
www.cgtn.com

SAN JOSE, Calif., – Good Samaritan Health System, which includes Regional Medical Center of San Jose, Good Samaritan Hospital, and Santa Clara County IPA (SCCIPA), an independent practice group with over 800 physicians, have entered into an alliance with Cigna to offer a simple, comprehensive and focused approach to quality care with improved affordability in Santa Clara County. Health plans will be available starting January 1, 2018.

The alliance also includes Pacific Partners Management Services (PPMSI), and both PPMSI and SCCIPA participate in the value-based Cigna Collaborative Care program. The Good Samaritan Health System hospitals and Pacific Partners are both subsidiaries of HCA Healthcare.

“By aligning Good Samaritan Health with a customized network of primary care doctors, specialists and hospitals, we’re creating a new kind of collaborative care initiative to offer Santa Clara County customers,” said Peter Welch, president for Cigna’s Northern California market. “Together we can help affiliated providers deliver measurably better care quality at a more affordable price by improving health care outcomes through the greater use of evidence-based best medical practices and more closely connecting the delivery of care for customers in need of acute treatment.”

The alliance will be governed by a joint operating committee comprising representatives from Cigna, Good Samaritan and SCCIPA.

“Together with Cigna and SCCIPA, we can develop health plans that achieve our common goals – better health and affordability, and a better experience for our patients,” said Joseph DeSchryver, chief executive officer, Good Samaritan Hospital. “When providers and payers work collaboratively, we can achieve better value for employers and individuals, greater quality in health care and stronger, healthier communities.”

“SCCIPA is pleased to be the physician network working with Cigna and the Good Samaritan Health System in this new collaboration in Santa Clara County,” said Dr. J. Kersten Kraft, SCCIPA’s president and chairman. “Our physician network has worked well with Cigna in a collaborative care arrangement for several years and has been among the highest performing physician groups in delivering high quality and coordinated health care. Expanding this relationship will bring this excellent care to more patients as they gain access to our doctors.”

The Santa Clara County alliance is Cigna’s fourth local alliance arrangement in California. The company also has local arrangements in Los Angeles, Orange and San Diego counties.

About Cigna
Cigna Corporation (NYSE: CI) is a global health service company dedicated to helping people improve their health, well-being and sense of security. All products and services are provided exclusively by or through operating subsidiaries of Cigna Corporation, including Cigna HealthCare of California, Inc., Cigna Health and Life Insurance Company, Connecticut General Life Insurance Company, Life Insurance Company of North America, Cigna Life Insurance Company of New York, or their affiliates. Such products and services include an integrated suite of health services, such as medical, dental, behavioral health, pharmacy, vision, supplemental benefits, and other related products including group life, accident and disability insurance. Cigna maintains sales capability in 30 countries and jurisdictions, and has more than 95 million customer relationships throughout the world. To learn more about Cigna®, including links to follow us on Facebook or Twitter, visit www.cigna.com .

About Good Samaritan Health System
The Good Samaritan Health System, which includes Regional Medical Center of San Jose and Good Samaritan Hospital-as well as three surgical centers and three Care Now Urgent Care centers, is committed to providing quality healthcare to residents throughout the greater Silicon Valley community. Good Samaritan Health provides a host of technologically-advanced services including cardiovascular, neurological, orthopedic, bariatric and general surgery, interventional pulmonology, along with multi-organ cancer care, and services for women and children. Good Samaritan Hospital and Regional Medical Center of San Jose are the nation’s first Joint Commission Certified Comprehensive Stroke Centers and are accredited Chest Pain Centers and Community Cancer Centers. For more information about the Good Samaritan Health System, visit www.goodsamhealthsystem.com .

About SCCIPA
SCCIPA operates like a clinic without walls, linking patients and health plans with our established network of physicians, hospitals, lab, x-ray, physical therapy and other providers. Based in San Jose, SCCIPA links over 800 physicians who practice independently throughout Santa Clara County, with 280 primary care physicians — specializing in family practice, internal medicine and pediatrics — and over 550 specialists who practice at most local hospitals.

The CMA has today issued a statement of objections to the pharmaceutical suppliers Pfizer and Flynn Pharma alleging that they have breached competition law.

Pill bottle with capsules
The Competition and Markets Authority’s (CMA) provisional view is that Pfizer and Flynn Pharma each abused a dominant position by charging excessive and unfair prices in the UK for phenytoin sodium capsules, an anti-epilepsy drug, in breach of UK and EU competition law.

Phenytoin sodium capsules are used in the treatment of epilepsy in order to prevent and control seizures and are an important drug for over 50,000 patients in the UK. Pfizer manufactures phenytoin sodium capsules and supplies them to Flynn Pharma, which then distributes them to UK wholesalers and pharmacies. The statement of objections concerns both the prices that Pfizer has charged to Flynn Pharma and the prices that Flynn Pharma has charged to its customers, since September 2012.

Prior to September 2012, Pfizer manufactured and sold phenytoin sodium capsules to UK wholesalers and pharmacies under the brand name Epanutin®. Pfizer sold the UK distribution rights for Epanutin® to Flynn Pharma, which de-branded (or genericised) the drug and started selling its version in September 2012. Pfizer continued to manufacture the drug, which it sold to Flynn at prices that were significantly higher than those at which it had previously sold Epanutin® in the UK – between 8 and 17 times Pfizer’s historic prices. Flynn then sold the drug on to customers at prices which were between 25 and 27 times higher than those historically charged by Pfizer.

Prior to September 2012, the NHS spent approximately £2.3 million on phenytoin sodium capsules annually. This spend (paid to Flynn and other suppliers of phenytoin sodium capsules) was just over £50 million in 2013 and over £40 million in 2014.

Ann Pope, CMA Senior Director of Antitrust Enforcement, said:

While businesses are generally free to set prices as they see fit, those that hold a dominant position have a special responsibility to ensure that their conduct does not impair genuine competition and that their prices are not excessive and unfair. The prices that the CMA is concerned about in this case are very high compared to those prices previously charged and have led to a big increase in the total NHS drug bill for what is a very important drug for tens of thousands of patients.

The CMA’s findings on dominance and abuse are provisional and no conclusion can be drawn at this stage that there has, in fact, been any breach of competition law. We will carefully consider any representations from Pfizer and Flynn Pharma before deciding whether the law has been infringed.

The CMA is the UK’s primary competition and consumer authority. It is an independent non-ministerial government department with responsibility for carrying out investigations into mergers, markets and the regulated industries and enforcing competition and certain consumer law. From 1 April 2014 it took over the functions of the Competition Commission and the competition and certain consumer functions of the Office of Fair Trading.
The Chapter II prohibition of the Competition Act 1998 prohibits the abuse of a dominant position by one or more undertakings which may affect trade within the UK or a part of it. Similarly, Article 102 of the Treaty on the Functioning of the European Union prohibits the abuse of a dominant position which may affect trade between EU Member States.

The CMA may impose a financial penalty on any business found to have infringed the Chapter II prohibition or Article 102 (or both) of up to 10% of its annual worldwide group turnover. In calculating financial penalties, the CMA takes into account a number of factors including seriousness of the infringement(s), turnover in the relevant market and any mitigating and/or aggravating factors.
Phenytoin sodium capsules are sold in 4 different strengths in the UK; 25mg, 50mg, 100mg and 300mg capsules. The statement of objections concerns the price that each of Pfizer and Flynn Pharma charged for each of those capsule strengths.
The statement of objections is addressed to the following companies, which the CMA provisionally considers were directly involved in the alleged infringements since September 2012:

Pfizer Limited
Flynn Pharma Limited
The statement of objections is also addressed to the following companies, which the CMA provisionally considers are jointly and severally liable as parent companies of the companies directly involved:
Pfizer Inc
Flynn Pharma (Holdings) Limited

A statement of objections gives parties notice of a proposed infringement decision under the competition law prohibitions in the Competition Act 1998 or the Treaty on the Functioning of the European Union. It is a provisional decision only and does not necessarily lead to an infringement decision. Parties have the opportunity to make written and oral representations on the matters set out in the statement of objections. Any such representations will be considered by the CMA before any final decision is made. The final decision is taken by a three-member case decision group, which is separate from the case investigation team and was not involved in the decision to issue the statement of objections.
The statement of objections will not be published. However, any person who wishes to comment on the CMA’s provisional findings, and who is in a position materially to assist the CMA in testing its factual, legal or economic arguments, may request a non-confidential version of the statement of objections by contacting the CMA no later than 31 August 2015.

Geneva – A new progress report is being jointly released today by the 13 signatory agencies of the Global Action Plan for Healthy Lives and Well-being for All (SDG3 GAP). The report entitled “What worked? What didn’t? What’s next?” reflects four years of joint work by major multilateral agencies outlining what has and has not worked in strengthening collaboration and support to accelerate country progress towards health-related Sustainable Development Goals (SDGs).

This year marks the halfway point toward the SDGs, but the world is lagging behind to reach the global goals. Since its launch in 2019, the SDG3 GAP enabled creation of new collaboration structures between the signatory agencies in key areas such as sustainable financing and primary health care among others. At least 67 countries engaged in on one or more of the SDG3 GAP accelerator themes.

“We have made important progress, but we still have a long path to travel to improve the way that multilateral organizations work together to support countries. We must listen to what countries tell us and act upon their guidance,” said Dr Tedros Adhanom Ghebreyesus, WHO Director-General and Chair of the SDG3 GAP Principals Group. “I thank the partners for their collaboration and for the honest self-assessments contained in this report.”

The report provides six key recommendations to ensure that countries benefit from a more streamlined support and to realize the commitments made in the SDG3 GAP. These include:

continue the SDG3 GAP improvement cycle for health by seeking the views of Member States on how we collaborate at country-level and responding to related recommendations;
maintain GAP as a platform for collaboration;
foster stronger collaboration at the country level on primary health care and explore new thematic topics such as climate resilient health systems;
jointly apply new approaches at country level such as the delivery for impact approach;
engage more with civil society; and
work with Member States to strengthen incentives for collaboration through political leadership, governance direction and funding to support collaboration.
Key findings of the report will feed into discussions of the next United Nations General Assembly SDG Summit and the High-level Meeting on Universal Health Coverage in September 2023.

The months leading up to these key events provide an opportunity for a joint push by Member States and multilateral agencies to identify ways on how to implement the recommendations and to prepare the ground to fully leverage stronger collaboration and accelerate progress towards the health-related SDGs in the second half of the SDG timeframe.

The SDG3 GAP describes how the 13 signatory agencies will adopt new ways of working, building on existing successful collaborations, and jointly align their support around national plans and strategies that are country-owned and -led. The signatories to the SDG3 GAP are Gavi, the Vaccine Alliance; Global Financing Facility for Women, Children and Adolescents (GFF); Global Fund to Fight AIDS, Tuberculosis and Malaria (Global Fund); International Labour Organization (ILO); Joint United Nations Programme on HIV/AIDS (UNAIDS); United Nations Development Programme (UNDP); United Nations Population Fund (UNFPA); United Nations Children’s Fund (UNICEF); Unitaid; United Nations Entity for Gender Equality and the Empowerment of Women (UN Women); World Bank Group; World Food Programme (WFP); and World Health Organization (WHO).

See full report: What worked? What didn’t? What’s next?: 2023 progress report on the global action plan for healthy lives and well-being for all (who.int)

LINK: Collaborating locally is key for progress globally towards health-related SDGs (who.int)

A receiver appointed to liquidate the assets of Filefax, Inc. has agreed to pay $ 100,000 out of the receivership estate to the U.S. Department of Health and Human Services (HHS) Office for Civil Rights (OCR) in order to settle potential violations of the Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule. Filefax, located in Northbrook, Illinois, advertised that it provided for the storage, maintenance, and delivery of medical records for covered entities. Although Filefax shut its doors during the course of OCR’s investigation into alleged HIPAA violations, it could not escape its obligations under the law.

On February 10, 2015, OCR received an anonymous complaint alleging that an individual transported medical records obtained from Filefax to a shredding and recycling facility to sell on February 6 and 9, 2015. OCR opened an investigation, which confirmed that an individual had left medical records of approximately 2,150 patients at the shredding and recycling facility, and that these medical records contained patients’ protected health information (PHI).

OCR’s investigation indicated that between January 28, 2015, and February 14, 2015, Filefax impermissibly disclosed the PHI of 2,150 individuals by leaving the PHI in an unlocked truck in the Filefax parking lot, or by granting permission to an unauthorized person to remove the PHI from Filefax, and leaving the PHI unsecured outside the Filefax facility.

“The careless handling of PHI is never acceptable,” said OCR Director Roger Severino. “Covered entities and business associates need to be aware that OCR is committed to enforcing HIPAA regardless of whether a covered entity is opening its doors or closing them. HIPAA still applies.”

Filefax is no longer in business. In 2016, a court in unrelated litigation appointed a receiver to liquidate its assets for distribution to creditors and others. In addition to a $100,000 monetary settlement, the receiver has agreed, on behalf of Filefax, to properly store and dispose of remaining medical records found at Filefax’s facility in compliance with HIPAA.

Geneva/Oslo 22 January 2021 – COVAX, the global initiative to ensure rapid and equitable access to COVID-19 vaccines for all countries, regardless of income level, today announced the signing of an advance purchase agreement with Pfizer for up to 40 million doses of the Pfizer-BioNTech vaccine candidate, which has already received WHO emergency use listing. Rollout will commence with the successful negotiation and execution of supply agreements.

In further support of its mission to expedite early availability of vaccines to lower-income countries and help bring a rapid end to the acute stage of the COVID-19 pandemic, COVAX also confirmed today that it will exercise an option – via an existing agreement with Serum Institute of India (SII) – to receive its first 100 million doses of the AstraZeneca/Oxford University-developed vaccine manufactured by SII.

Of these first 100 million doses, the majority are earmarked for delivery in the first quarter of the year, pending WHO Emergency Use Listing. The WHO review process, which is currently underway, follows approval for restricted use in emergency situations by the Drugs Controller General of India earlier this month, and is a critical aspect of ensuring that any vaccine procured through COVAX is fully quality assured for international use. According to the latest WHO update, a decision on this vaccine candidate is anticipated by the middle of February.

COVAX also anticipates that, via an existing agreement with AstraZeneca, at least 50 million further doses of the AstraZeneca/Oxford vaccine will be available for delivery to COVAX participants in Q1 2021, pending emergency use listing by WHO of the COVAX-specific manufacturing network for these doses. A decision on this candidate is also anticipated by WHO in February.

“Today marks another milestone for COVAX: pending regulatory approval for the AstraZeneca/Oxford candidate and pending the successful conclusion of the supply agreement for the Pfizer-BioNTech vaccine, we anticipate being able to begin deliveries of life-saving COVID-19 vaccines by the end of February. This is not just significant for COVAX, it is a major step forward for equitable access to vaccines, and an essential part of the global effort to beat this pandemic. We will only be safe anywhere if we are safe everywhere,” said Dr Seth Berkley, CEO of Gavi, the Vaccine Alliance, which leads COVAX procurement and delivery.

Preparations, led by WHO, UNICEF and Gavi, are already well under way for COVAX to deliver vaccines to economies eligible for support via the COVAX AMC, with Gavi making US$ 150 million available from its core funding as initial, catalytic support for preparedness and delivery.

“The urgent and equitable rollout of vaccines is not just a moral imperative, it’s also a health security, strategic and economic imperative,” said Dr Tedros Adhanom Ghebreyesus, Director-General of the World Health Organization. “This agreement with Pfizer will help to enable COVAX to save lives, stabilize health systems and drive the global economic recovery.”

Building on the work of the past months supporting country readiness efforts, a “Country Readiness Portal” will be launched by WHO this month, which will allow AMC participants to submit final national deployment and vaccination plans (NDVPs). This is a vital step before allocations can be made, to ensure that delivered doses are able to be effectively deployed and to identify where, if necessary, further support is needed.

“These purchase agreements open the door for these lifesaving vaccines to become available to people in the most vulnerable countries,” said UNICEF Executive Director Henrietta Fore. “But at the same time we are securing vaccines we must also ensure that countries are ready to receive them, deploy them, and build trust in them.”

The COVAX Facility intends to provide all 190 participating economies with an indicative allocation of doses by the end of this month. This indicative allocation will provide interim guidance to participants – offering a minimum planning scenario to enable preparations for the final allocation of the number of doses each participant will receive in the first rounds of vaccine distribution.

Supply update

COVAX now has agreements in place to access just over two billion doses of several promising vaccine candidates. Negotiations continue for further doses to be secured through existing R&D agreements by COVAX co-lead the Coalition for Epidemic Preparedness Innovations (CEPI), through evaluations of new products with promising results and through contributions from donors.

Based on this, COVAX anticipates being able to provide participating economies doses of safe and effective vaccines – enough to protect health care and other frontline workers as well as some high-risk individuals – beginning in Q1 2021. The aim is to protect at least 20% of each participating population by the end of the year – unless a participant has requested a lower percentage of doses. At least 1.3 billion of these doses will be made available to the 92 economies eligible for the Gavi COVAX AMC by the end of 2021.

To meet its goal of securing two billion safe and effective vaccines in 2021, COVAX has built a diverse portfolio of vaccine candidates which mitigates the risk of a product failing development, production or regulatory processes, and ensures availability of products suitable for various contexts and settings. This work will continue at pace to enable further supply of vaccines suitable for use across a wide range of populations and settings in 2021 and beyond.

“The progress in vaccine development so far has been extraordinary, and it is clear that we are now assembling the tools we need to bring the acute phase of the pandemic to an end. But we cannot afford to slow our efforts given the speed with which this pandemic continues to wreak havoc,” said Dr Richard Hatchett, CEO of CEPI. “The emergence of new variants of COVID-19 puts into sharp focus the need for us to be one step ahead of the virus by continuing to invest in vaccine R&D – specifically for next-generation vaccine candidates and to be ready for strain changes in existing vaccines – to ensure we have the tools to meet the needs of all populations in all countries for the long term.”

About COVAX
COVAX, the vaccines pillar of the Access to COVID-19 Tools (ACT) Accelerator, is co-led by CEPI, Gavi and WHO – working in partnership with developed and developing country vaccine manufacturers, UNICEF, the World Bank, and others. It is the only global initiative that is working with governments and manufacturers to ensure COVID-19 vaccines are available worldwide to both higher-income and lower-income countries.

CEPI is leading on the COVAX vaccine research and development portfolio, investing in R&D across a variety of promising candidates, with the goal to support development of three safe and effective vaccines which can be made available to countries participating in the COVAX Facility. As part of this work, CEPI has secured first right of refusal to potentially over one billion doses for the COVAX Facility to a number of candidates, and made strategic investments in vaccine manufacturing, which includes reserving capacity to manufacture doses of COVAX vaccines at a network of facilities, and securing glass vials to hold 2 billion doses of vaccine. CEPI is also investing in the ‘next generation’ of vaccine candidates, which will give the world additional options to control COVID-19 in the future.

Gavi is leading on procurement and delivery for COVAX, coordinating the design and implementation of the COVAX Facility and the COVAX AMC and working with Alliance partners UNICEF and WHO, along with governments, on country readiness and delivery. The COVAX Facility is the global pooled procurement mechanism for COVID-19 vaccines through which COVAX will ensure fair and equitable access to vaccines for all 190 participating economies, using an allocation framework formulated by WHO. The COVAX Facility will do this by pooling buying power from participating economies and providing volume guarantees across a range of promising vaccine candidates. The Gavi COVAX AMC is the financing mechanism that will support the participation of 92 low- and middle-income countries in the Facility, enabling access to donor-funded doses of safe and effective vaccines. UNICEF and the Pan-American Health Organisation (PAHO) will be acting as procurement coordinators for the COVAX Facility, helping deliver vaccines to all participants.

WHO has multiple roles within the COVAX: among other things it supports countries as they prepare to receive and administer vaccines and does so in partnership with UNICEF. It provides normative guidance on vaccine policy, regulation, safety, R&D, allocation, and country readiness and delivery. Its Strategic Advisory Group of Experts (SAGE) on Immunization develops evidence-based immunization policy recommendations. Its Emergency Use Listing (EUL)/prequalification programmes ensure harmonized review and authorization across member states. It provides global coordination and member state support on vaccine safety monitoring. It developed the target product profiles for COVID-19 vaccines and provides R&D technical coordination. Along with COVAX partners, it is developing a no-fault compensation scheme for indemnification and liability issues. COVAX is part of the Act accelerator which WHO launched with partners in 2020.

About Gavi, the Vaccine Alliance
Gavi, the Vaccine Alliance is a public-private partnership that helps vaccinate half the world’s children against some of the world’s deadliest diseases. Since its inception in 2000, Gavi has helped to immunise a whole generation – over 822 million children – and prevented more than 14 million deaths, helping to halve child mortality in 73 lower-income countries. Gavi also plays a key role in improving global health security by supporting health systems as well as funding global stockpiles for Ebola, cholera, meningitis and yellow fever vaccines. After two decades of progress, Gavi is now focused on protecting the next generation and reaching the unvaccinated children still being left behind, employing innovative finance and the latest technology – from drones to biometrics – to save millions more lives, prevent outbreaks before they can spread and help countries on the road to self-sufficiency. Learn more at www.gavi.org and connect with us on Facebook and Twitter.

The Vaccine Alliance brings together developing country and donor governments, the World Health Organization, UNICEF, the World Bank, the vaccine industry, technical agencies, civil society, the Bill & Melinda Gates Foundation and other private sector partners. View the full list of donor governments and other leading organizations that fund Gavi’s work here.

About CEPI
CEPI is an innovative partnership between public, private, philanthropic, and civil organisations, launched at Davos in 2017, to develop vaccines to stop future epidemics. CEPI has moved with great urgency and in coordination with WHO in response to the emergence of COVID-19. CEPI has initiated 11 partnerships to develop vaccines against the novel coronavirus. The programmes are leveraging rapid response platforms already supported by CEPI as well as new partnerships.

Before the emergence of COVID-19, CEPI’s priority diseases included Ebola virus, Lassa virus, Middle East Respiratory Syndrome coronavirus, Nipah virus, Rift Valley Fever and Chikungunya virus. CEPI also invested in platform technologies that can be used for rapid vaccine and immunoprophylactic development against unknown pathogens (Disease X).

About WHO
The World Health Organization provides global leadership in public health within the United Nations system. Founded in 1948, WHO works with 194 Member States, across six regions and from more than 150 offices, to promote health, keep the world safe and serve the vulnerable. Our goal for 2019-2023 is to ensure that a billion more people have universal health coverage, to protect a billion more people from health emergencies, and provide a further billion people with better health and wellbeing.

For updates on COVID-19 and public health advice to protect yourself from coronavirus, visit www.who.int and follow WHO on Twitter, Facebook, Instagram, LinkedIn, TikTok, Pinterest, Snapchat, YouTube

About ACT-Accelerator
The Access to COVID-19 Tools ACT-Accelerator, is a new, ground-breaking global collaboration to accelerate the development, production, and equitable access to COVID-19 tests, treatments, and vaccines. It was set up in response to a call from G20 leaders in March and launched by the WHO, European Commission, France and The Bill & Melinda Gates Foundation in April 2020.

The ACT-Accelerator is not a decision-making body or a new organisation, but works to speed up collaborative efforts among existing organisations to end the pandemic. It is a framework for collaboration that has been designed to bring key players around the table with the goal of ending the pandemic as quickly as possible through the accelerated development, equitable allocation, and scaled up delivery of tests, treatments and vaccines, thereby protecting health systems and restoring societies and economies in the near term. It draws on the experience of leading global health organisations which are tackling the world’s toughest health challenges, and who, by working together, are able to unlock new and more ambitious results against COVID-19. Its members share a commitment to ensure all people have access to all the tools needed to defeat COVID-19 and to work with unprecedented levels of partnership to achieve it.

The ACT-Accelerator has four areas of work: diagnostics, therapeutics, vaccines and the health system connector. Cross-cutting all of these is the workstream on Access & Allocation.

An estimated 1.4 million fewer people received care for tuberculosis (TB) in 2020 than in 2019, according to preliminary data compiled by the World Health Organization (WHO) from over 80 countries- a reduction of 21% from 2019. The countries with the biggest relative gaps were Indonesia (42%), South Africa (41%), Philippines (37%) and India (25%).

“The effects of COVID-19 go far beyond the death and disease caused by the virus itself. The disruption to essential services for people with TB is just one tragic example of the ways the pandemic is disproportionately affecting some of the world’s poorest people, who were already at higher risk for TB,” said Dr Tedros Adhanom Ghebreyesus, WHO Director-General. “These sobering data point to the need for countries to make universal health coverage a key priority as they respond to and recover from the pandemic, to ensure access to essential services for TB and all diseases.”

Building up health systems so everyone can get the services they need is key. Some countries have already taken steps to mitigate the impact of COVID-19 on service delivery, by strengthening infection control; expanding use of digital technologies to provide remote advice and support, and providing home-based TB prevention and care.

But many people who have TB are unable to access the care they need. WHO fears that over half a million more people may have died from TB in 2020, simply because they were unable to obtain a diagnosis.

This is not a new problem: before COVID-19 struck, the gap between the estimated number of people developing TB each year and the annual number of people officially reported as diagnosed with TB was about 3 million. The pandemic has greatly exacerbated the situation.

One way to address this is through restored and improved TB screening to rapidly identify people with TB infection or TB disease.  New guidance issued by WHO on World TB Day aims to help countries identify the specific needs of communities, the populations at highest risk of TB, and the locations most affected to ensure people can access the most appropriate prevention and care services. This can be achieved through a more systematic use of screening approaches that employ novel tools.

These include the use of molecular rapid diagnostic tests, the use of computer-aided detection to interpret chest radiography and the use of a wider range of approaches for screening people living with HIV for TB. The recommendations are accompanied by an operational guide to facilitate roll-out.

But this will not be enough alone. In 2020, in his report to the United Nations General Assembly,  the UN Secretary General issued a set of 10 priority recommendations that countries need to follow. These include activating high-level leadership and action across multiple sectors to urgently reduce TB deaths; increasing funding; advancing universal health coverage for TB prevention and care; addressing drug resistance, promoting human rights and intensifying TB research.

And critically, it will be vital to reduce health inequities.

“For centuries, people with TB have been among the most marginalized and vulnerable. COVID-19 has intensified the disparities in living conditions and ability to access services both within and between countries,” says Dr Tereza Kasaeva, Director of WHO’s Global TB Programme. “We must now make a renewed effort to work together to ensure that TB programmes are strong enough to deliver during any future emergency – and look for innovative ways to do this.”

1 June 2020 – GENEVA – Prevention and treatment services for noncommunicable diseases (NCDs) have been severely disrupted since the COVID-19 pandemic began, according to a WHO survey released today. The survey, which was completed by 155 countries during a 3-week period in May, confirmed that the impact is global, but that low-income countries are most affected.

This situation is of significant concern because people living with NCDs are at higher risk of severe COVID-19-related illness and death.

“The results of this survey confirm what we have been hearing from countries for a number of weeks now,” said Dr Tedros Adhanom Ghebreyesus, Director-General of the World Health Organization. “Many people who need treatment for diseases like cancer, cardiovascular disease and diabetes have not been receiving the health services and medicines they need since the COVID-19 pandemic began. It’s vital that countries find innovative ways to ensure that essential services for NCDs continue, even as they fight COVID-19.”

Service disruptions are widespread

The main finding is that health services have been partially or completely disrupted in many countries. More than half (53%) of the countries surveyed have partially or completely disrupted services for hypertension treatment; 49% for treatment for diabetes and diabetes-related complications; 42% for cancer treatment, and 31% for cardiovascular emergencies.

Rehabilitation services have been disrupted in almost two-thirds (63%) of countries, even though rehabilitation is key to a healthy recovery following severe illness from COVID-19.

Reassignment of staff and postponing of screening

In the majority (94%) of countries responding, ministry of health staff working in the area of NCDs were partially or fully reassigned to support COVID-19.

The postponement of public screening programmes (for example for breast and cervical cancer) was also widespread, reported by more than 50% of countries. This was consistent with initial WHO recommendations to minimize non-urgent facility-based care whilst tackling the pandemic.

But the most common reasons for discontinuing or reducing services were cancellations of planned treatments, a decrease in public transport available and a lack of staff because health workers had been reassigned to support COVID19 services. In one in five countries (20%) reporting disruptions, one of the main reasons for discontinuing services was a shortage of  medicines, diagnostics and other technologies.

Unsurprisingly, there appears to be a correlation between levels of disruption to services for treating NCDs and the evolution of the COVID-19 outbreak in a country.  Services become increasingly disrupted as a country moves from sporadic cases to community transmission of the coronavirus.

Globally, two-thirds of countries reported that they had included NCD services in their national COVID-19 preparedness and response plans; 72% of high-income countries reported inclusion compared to 42% of low-income countries. Services to address cardiovascular disease, cancer, diabetes and chronic respiratory disease were the most frequently included. Dental services, rehabilitation and tobacco cessation activities were not as widely included in response plans according to country reports.

Seventeen percent of countries reporting have started to allocate additional funding from the government budget to include the provision of NCD services in their national COVID-19 plan.

Alternative strategies for continuing care being implemented

Encouraging findings of the survey were that alternative strategies have been established in most countries to support the people at highest risk to continue receiving treatment for NCDs. Among the countries reporting service disruptions, globally 58% of countries are now using telemedicine (advice by telephone or online means) to replace in-person consultations; in low-income countries this figure is 42%. Triaging to determine priorities has also been widely used, in two-thirds of countries reporting.

Also encouraging is that more than 70% of countries reported collecting data on the number of COVID-19 patients who also have an NCD.

”It will be some time before we know the full extent of the impact of disruptions to health care during COVID-19 on people with noncommunicable diseases,” said Dr Bente Mikkelsen, Director of the Department of Noncommunicable Diseases at WHO. “What we know now, however, is that not only are people with NCDs more vulnerable to becoming seriously ill with the virus, but many are unable to access the treatment they need to manage their illnesses. It is very important not only that care for people living with NCDs is included in national response and preparedness plans for COVID-19 -̶  but that innovative ways are found to implement those plans . We must be ready to “build back better”  ̶  strengthening health services so that they are better equipped to prevent, diagnose and provide care for NCDs in the future, in any circumstances.”

SAN ANTONIO– Celebrating its 25th Annual Conference this week in San Antonio, Texas, the Hispanic Dental Association (HDA) is renewing its commitment with trusted partners Crest® and Oral-B® to together improve the oral health of the growing U.S. Hispanic population. Details of the exclusive partnership will be revealed during a reception on Aug. 14 honoring the winners of the HDA’s Orgullo Program, an annual competition sponsored by Procter and Gamble (P&G) oral care brands.

“Our collaborative work with the Hispanic Dental Association has helped shed light on many of the challenges1 faced by U.S. Hispanics when it comes to their oral health,” said Iván Lugo, DMD, MBA and P&G spokesperson. “We are proud to continue to support the work of Hispanic oral health professionals across the nation to turn awareness into action with an emphasis on prevention to help close the oral health gap that prevails in the community.”

The Friday evening reception, which brings together Hispanic oral health professionals and students to celebrate the next generation of dental professionals, will also mark the official unveiling of a new HDA/Crest stamp to be used exclusively by Crest and Oral-B in materials developed in conjunction with the HDA over the next two years to promote good oral health habits.

“Our collaboration with Crest and Oral-B has helped debunk top misperceptions about Hispanic oral care and educate the community through the distribution of oral health materials in Spanish to dental offices, professional schools and associations, ” said David Peña, Jr., executive director/CEO, Hispanic Dental Association. “We are thrilled to expand our partnership to further improve the state of oral health in the Hispanic community.”

About the Hispanic Dental Association (HDA)
The Hispanic Dental Association is a national, non-profit organization comprised of oral health professionals and students dedicated to promoting and improving the oral health of the Hispanic community and providing advocacy for Hispanic oral health professionals across the U.S. The Association works with a wide spectrum of individuals and organizations to communicate to Hispanic and non-Hispanic dental professionals, students and the public.

About Crest
A trusted leader in oral health, Crest was the first oral care brand to secure the ADA Seal of Acceptance for a clinically proven fluoride toothpaste. Since first introducing fluoride toothpaste 54 years ago, it is estimated that Crest has helped prevent more than half a billion cavities in the United States. Headquartered in Cincinnati, OH, Crest is owned and distributed by The Procter & Gamble Company.

About Oral-B
Oral-B is the worldwide leader in the over $5 billion brushing market. Part of Procter & Gamble, the brand includes manual and power toothbrushes for children and adults, oral irrigators and interdental products, such as dental floss. Oral-B toothbrushes are used by more dentists in the world than any other brand.

About Procter & Gamble
P&G serves consumers around the world with one of the strongest portfolios of trusted, quality, leadership brands, including Always®, Ambi Pur®, Ariel®, Bounty®, Charmin®, Crest®, Dawn®, Downy®, Fairy®, Febreze®, Gain®, Gillette®, Head & Shoulders®, Lenor®, Olay®, Oral-B®, Pampers®, Pantene®, SK-II®, Tide®, Vicks®, and Whisper®. The P&G community includes operations in approximately 70 countries worldwide. Please visit http://www.pg.com for the latest news and information about P&G and its brands.

Las Vegas, NV
For the second year in a row at CES® in Las Vegas, the Consumer Technology Association (CTA)® Foundation will host a business pitch contest – sponsored by AARP Innovation Labs – to recognize sports, fitness and related innovations that can provide health solutions to help people stay in the game as they age.

Professional Football Hall of Fame quarterback Joe Montana will be the event moderator. AARP CEO Jo Ann Jenkins, CTA Foundation Executive Director Stephen Ewell, and P&G VP of Innovation Capability Julie Setser will join a panel of industry thought leaders as judges. The contest is on Thursday, Jan. 9, 2020, at 1 p.m. PT at the startup stage in Eureka Park at the Sands – all CES 2020 attendees are invited to attend and help select the winner.

The eight companies invited to pitch are:

CareWear (Nevada, USA) – This is a wearable, wireless, FDA-registered LED light patches for athletes in all sports. CareWear Light Patches are designed to help reduce pain and accelerate recovery.

Naolu Brain Tech BrainUp (Beijing, China) – A brain-computer interface product KANG is like a gym but for the brain, designed to provide various practical applications such as 20 minutes deep sleep aid, brain and mental state examination, and brain training programs.

Rothem (Kyiv, Ukraine) – Smart bicycle backlight is a device invented to help predict collisions between a bicycle and a vehicle and warns the vehicle driver before the collision happens with a loud sound and flashes of the backlight.

SmartyPans (California, USA) – SmartyPans is a sensor-enabled cookware that automatically computes nutrition information of home cooked meals and allows users to create their own recipes, which are formatted by AI.

Strig (Gyeonggi-do, South Korea) – Strig is a massage tool with micro-current and micro-vibration that is designed to help relieve muscle pain and aid in faster recovery.

Triple W (California, USA) – DFree is a wearable device. Its purpose is to help predict when you need to go to the bathroom. Its sensor uses ultrasound to continuously monitor your bladder and sends notification to your phone when your bladder is almost full so you know when to go.

Yoganotch (New York, USA) – Yoganotch is an AI yoga coach in which people wear a few tiny Notch sensors designed to help them practice yoga more safely and efficiently with real-time personalized feedback on their technique.

Zibrio (Texas, USA) – The Zibrio SmartScale uses a highly sensitive algorithm to help measure a person’s postural stability and fall risk in a 60 second standing test.

“We had an incredible response from companies creating innovative solutions that can help to keep us active as we age,” said Stephen Ewell, executive director of the CTA Foundation, which links seniors and people with disabilities with technologies to enhance their lives. “I look forward to seeing them compete at CES 2020 and selecting a winner but, ultimately, calling attention to innovations in accessibility technology is a win for everyone.”

In the U.S., the connected solutions market for seniors is expected to reach nearly $30 billion by 2022, according to a recent study by CTA.

For more information on the CTA Foundation, this event, and all their CES 2020 activities, visit https://www.cta.tech/Who-We-Are/CTA-Foundation/CES-2020.

Las Vegas, NV
Today, the Consumer Technology Association (CTA)® and Heart Rhythm Society (HRS) released a unique digital health paper recommending best practices for using wearable technology to manage personal health, including detecting and monitoring cardiovascular biometrics. Presented for the first time during a panel at CES® 2020 – the world’s largest, most influential tech event – this paper provides consumer guidance on understanding devices and managing their personal health data.

“The collaboration between HRS and CTA is timely and important for both consumers and clinicians,” said Dr. Andrea Russo, president, HRS. “Chronic diseases are increasing in prevalence and wearables help people monitor their health to aid in earlier diagnosis and better management of their conditions; furthermore, they provide information to the user that fosters a healthier lifestyle.”

“Digital health is changing lives for the better – providing more personalized care, delivering better outcomes and lowering costs,” said Rene Quashie, VP of digital health, CTA. “Wearable solutions are one of the fastest growing sectors in technology. And as more consumers capture personal health information, a cross industry-created guidance document has never been more important to provide clarity on the potential health and wellness benefits of wearables.”

The CTA/HRS Guidance for Wearable Health Solutions paper includes an overview of the wearables landscape and offers advice for consumers on using wearables. A FAQ section tackles topics including data management, when to call a doctor, sharing data with a health provider, data privacy and security policies.

Developed and reviewed by physicians, patient advocates, technology companies and health care organizations, CTA and HRS created these guidelines to answer common questions for consumers that currently own – or want to own – wearables that capture personal health information. The best practices were presented at the Disruptive Innovations in Health Care conference track at CES.

Dr. Nassir Marrouche, lead author of the paper, added, “in this document we aimed to highlight this new intersection between consumer tech and health. We want people to be aware of what these wearables have to offer, how they can increase knowledge about one’s health, and how clinicians are optimistic about the data wearables can deliver.”

According to recent data, CTA projects total sales of digital health devices in the U.S. – such as smartwatches, fitness trackers and blood pressure monitors – will reach $10 billion in revenue in 2020 (up by 16% over last year).

The Health & Wellness category at CES 2020 will have over 20% more exhibitors and 15% more exhibitor space than CES 2019, with notable exhibitors such as Abbott, Cigna, Humana, Omron Healthcare, Myant, Philips and Procter & Gamble.

To download the CTA/HRS Guidance for Wearable Health Solutions document, visit CTA.tech.

WOONSOCKET, R.I., –CVS Caremark (NYSE: CVS) announced today it has entered into a new clinical affiliation with MedStar Health, a leading health care system with ten hospitals in Maryland and the Washington, DC, region, which will enhance access to high-quality, affordable health care services for patients. Through this clinical affiliation, MedStar Health patients will continue to have access to clinical support, medication counseling, chronic disease monitoring and wellness programs at CVS/pharmacy stores and MinuteClinic, the retail health care division of CVS Caremark. In addition, CVS Caremark will provide critical prescription and visit information to the affiliated health care providers through the integration of secured electronic medical record (EMR) systems.

CVS/pharmacy currently has about 7,700 retail pharmacy locations across the U.S. where CVS pharmacists provide counseling to patients to help them be adherent to their chronic disease medications. Of the total retail pharmacy locations, more than 860 MinuteClinic walk-in medical clinics are available. MinuteClinic locations are open seven days a week, offering evening hours with no appointment necessary and most health insurance is accepted. The clinics are staffed by nurse practitioners who provide treatment for common family illnesses and administer wellness and prevention services, including health-condition monitoring for patients with chronic diseases.

“We look forward to working with MedStar Health to develop collaborative programs that improve patient outcomes, lower costs and help people on their path to better health,” said Troyen A. Brennan, MD, Chief Medical Officer, CVS Caremark. “Through this clinical affiliation, we will also be integrating our electronic medical records and information systems to enable us to support patients with medication counseling and chronic disease monitoring.”

The participating health care providers will receive data on interventions conducted by CVS pharmacists to improve medication adherence for their patients. The affiliation also encourages collaboration between the health care providers and MinuteClinic providers to improve coordination of care for patients seen at MinuteClinic locations. Affiliated physicians will collaborate with MinuteClinic nurse practitioners to work closely on joint clinical programs and care coordination activities. If more comprehensive care is needed, patients can follow up with their primary care provider and have access to the services at the health care provider as appropriate. For those patients who do not have regular access to health care, MinuteClinic provides assistance in finding a primary care physician and a greater opportunity for continuity of health care services.

“Finding cost-effective ways to increase access to care continues to be important, especially in this era of health care reform, and we are pleased to work together with health care providers to help coordinate comprehensive care for their patients,” said Dr. Brennan. “Many patients rely on their local pharmacist for information and support regarding their prescription medications and these types of affiliations enable CVS pharmacists to help improve affiliated health care providers’ patient health outcomes through better medication adherence. MinuteClinic also plays an important role by providing patients with timely, affordable and high-quality walk-in medical care.”

MinuteClinic, CVS/pharmacy and MedStar Health will begin to work toward integrating EMR systems to streamline communication around all aspects of each individual patient’s care. This integration will include the electronic sharing of messages and alerts from CVS/pharmacy to MedStar Health physicians regarding potential medication non-adherence issues. In addition, MinuteClinic will electronically share medical histories and visit summaries with the patient’s primary care provider at MedStar Health. MinuteClinic will also continue its standard practice of sending patient visit summaries to primary care providers who are not affiliated with a participating health care provider via fax or mail, typically within 24 hours, with patient consent.

The new clinical affiliation announced here brings the total number of health system and health care provider affiliations for CVS Caremark and MinuteClinic to 41 major health systems and health care providers across the country. This new affiliation includes clinical collaborations with MinuteClinic combined with data on interventions performed by CVS pharmacists.

About CVS Caremark
CVS Caremark is dedicated to helping people on their path to better health as the largest integrated pharmacy company in the United States. Through the company’s more than 7,700 CVS/pharmacy stores; its leading pharmacy benefit manager serving nearly 65 million plan members; and its retail health clinic system, the largest in the nation with more than 860 MinuteClinic locations, it is a market leader in mail order, retail and specialty pharmacy, retail clinics, and Medicare Part D Prescription Drug Plans. As a pharmacy innovation company with an unmatched breadth of capabilities, CVS Caremark continually strives to improve health and lower costs by developing new approaches such as its unique Pharmacy Advisor program that helps people with chronic diseases such as diabetes obtain and stay on their medications. Find more information about how CVS Caremark is reinventing pharmacy for better health at info.cvscaremark.com.

WOONSOCKET, R.I., — CVS Caremark (NYSE: CVS) announced today it has entered into new clinical affiliations with four major health care providers to enhance access to high-quality, affordable health care services for patients. The collaborating health care providers include ProHealth Physicians in Connecticut, Texas Health Resources in Texas, Palmetto Health in South Carolina and The Baton Rouge Clinic in Louisiana. Through these clinical affiliations the patients of these health care providers will receive access to clinical support, medication counseling, chronic disease monitoring and wellness programs at CVS/pharmacy stores and MinuteClinic, the retail health care division of CVS Caremark. In addition, CVS Caremark will provide critical prescription and visit information to those health care providers through the integration of secured electronic medical record (EMR) systems.

CVS/pharmacy currently has more than 7,600 retail pharmacy locations across the U.S. where CVS pharmacists provide counseling to patients to help them be adherent to their chronic disease medications. Of the total retail pharmacy locations, more than 800 MinuteClinic walk-in medical clinics are available. MinuteClinic locations are open seven days a week, offering evening hours with no appointment necessary and most health insurance is accepted. The clinics are staffed by nurse practitioners who provide treatment for common family illnesses and administer wellness and prevention services, including health-condition monitoring for patients with chronic diseases.

“We look forward to working with these health care providers to develop collaborative programs that improve patient outcomes, lower costs and help people on their path to better health,” said Troyen A. Brennan, MD, Chief Medical Officer, CVS Caremark. “Through these clinical affiliations, we will also be integrating our electronic medical records and information systems to enable us to support patients with medication counseling and chronic disease monitoring.”

The participating health care providers will receive data on interventions conducted by CVS pharmacists to improve medication adherence for their patients. The affiliation also encourages collaboration between the health care providers and MinuteClinic providers to improve coordination of care for patients seen at MinuteClinic locations. Physicians affiliated with the participating health care providers will collaborate with MinuteClinic nurse practitioners to work closely on joint clinical programs and care coordination activities. If more comprehensive care is needed, patients can follow up with their primary care provider and have access to the services at the health care provider as appropriate. For those patients who do not have regular access to health care, MinuteClinic provides assistance in finding a primary care physician and a greater opportunity for continuity of health care services.

“Finding cost-effective ways to increase access to care continues to be important, especially in this era of health care reform, and we are pleased to work together with these health care providers to help coordinate comprehensive care for their patients,” said Dr. Brennan. “Many patients rely on their local pharmacist for information and support regarding their prescription medications and these affiliations enable CVS pharmacists to help improve affiliated health care providers’ patient health outcomes through better medication adherence. MinuteClinic also plays an important role by providing patients with timely, affordable and high-quality walk-in health care.”

MinuteClinic, CVS/pharmacy and the participating health care providers will begin to work toward integrating EMR systems to streamline communication around all aspects of each individual patient’s care. This integration will include the electronic sharing of messages and alerts from CVS/pharmacy to the health care providers’ physicians regarding potential medication non-adherence issues. In addition, MinuteClinic will electronically share medical histories and visit summaries with the patient’s primary care provider when they are a member of a participating health care provider. MinuteClinic will continue its standard practice of sending patient visit summaries to primary care providers who are not affiliated with one of these participating health care providers via fax or mail, typically within 24 hours, with patient consent.

The new clinical affiliations announced here bring the total number of health system and health care provider affiliations for CVS Caremark and MinuteClinic to 40 major health systems and health care providers across the country. These four new affiliations include clinical collaborations with MinuteClinic combined with data on interventions performed by CVS pharmacists.

About CVS Caremark
CVS Caremark is dedicated to helping people on their path to better health as the largest integrated pharmacy company in the United States. Through the company’s more than 7,600 CVS/pharmacy stores; its leading pharmacy benefit manager serving more than 64 million plan members; and its retail health clinic system, the largest in the nation with more than 800 MinuteClinic locations, it is a market leader in mail order, retail and specialty pharmacy, retail clinics, and Medicare Part D Prescription Drug Plans. As a pharmacy innovation company with an unmatched breadth of capabilities, CVS Caremark continually strives to improve health and lower costs by developing new approaches such as its unique Pharmacy Advisor program that helps people with chronic diseases such as diabetes obtain and stay on their medications. Find more information about how CVS Caremark is reinventing pharmacy for better health at info.cvscaremark.com.

WOONSOCKET, R.I.-CVS Caremark (NYSE: CVS) announced today that it will stop selling cigarettes and other tobacco products at its more than 7,600 CVS/pharmacy stores across the U.S. by October 1, 2014, making CVS/pharmacy the first national pharmacy chain to take this step in support of the health and well-being of its patients and customers.

“Ending the sale of cigarettes and tobacco products at CVS/pharmacy is the right thing for us to do for our customers and our company to help people on their path to better health,” said Larry J. Merlo, President and CEO, CVS Caremark. “Put simply, the sale of tobacco products is inconsistent with our purpose.”

Merlo continued, “As the delivery of health care evolves with an emphasis on better health outcomes, reducing chronic disease and controlling costs, CVS Caremark is playing an expanded role in providing care through our pharmacists and nurse practitioners. The significant action we’re taking today by removing tobacco products from our retail shelves further distinguishes us in how we are serving our patients, clients and health care providers and better positions us for continued growth in the evolving health care marketplace.”

Smoking is the leading cause of premature disease and death in the United States with more than 480,000 deaths annually. While the prevalence of cigarette smoking has decreased from approximately 42 percent of adults in 1965 to 18 percent today, the rate of reduction in smoking prevalence has stalled in the past decade. More interventions, such as reducing the availability of cigarettes, are needed.

“CVS Caremark is continually looking for ways to promote health and reduce the burden of disease,” said CVS Caremark Chief Medical Officer Troyen A. Brennan, M.D., M.P.H. “Stopping the sale of cigarettes and tobacco will make a significant difference in reducing the chronic illnesses associated with tobacco use.”

In a Journal of the American Medical Association (JAMA) Viewpoint published online this morning, Brennan and co-author Steven A. Schroeder, Director, Smoking Cessation Leadership Center, University of California, San Francisco, wrote, “The paradox of cigarette sales in pharmacies has become even more relevant recently, in large part because of changes in the pharmacy industryMost pharmacy chains are retooling themselves as an integral part of the health care system. They are offering more counseling by pharmacists, an array of wellness products and outreach to clinicians and health care centers.Perhaps more important, pharmacies are moving into the treatment arena, with the advent of retail health clinics. These retail clinics, originally designed to address common acute infections, are gearing up to work with primary care clinicians to assist in treating hypertension, hyperlipidemia and diabetes all conditions exacerbated by smoking.”

CVS Caremark’s decision to stop selling tobacco products is consistent with the positions taken by the American Medical Association, American Heart Association, American Cancer Society, American Lung Association and American Pharmacists Association that have all publicly opposed tobacco sales in retail outlets with pharmacies.

“As a leader of the health care community focused on improving health outcomes, we are pledging to help millions of Americans quit smoking,” said Merlo. “In addition to removing cigarettes and tobacco products for sale, we will undertake a robust national smoking cessation program.”

The program, to be launched this Spring, is expected to include information and treatment on smoking cessation at CVS/pharmacy and MinuteClinic along with online resources. The program will be available broadly across all CVS/pharmacy and MinuteClinic locations and will offer additional comprehensive programs for CVS Caremark pharmacy benefit management plan members to help them to quit smoking. Approximately seven in ten smokers say they want to quit and about half attempt to quit each year.

“Every day, all across the country, customers and patients place their trust in our 26,000 pharmacists and nurse practitioners to serve their health care needs,” commented Helena B. Foulkes, President, CVS/pharmacy. “Removing tobacco products from our stores is an important step in helping Americans to quit smoking and get healthy.”

The decision to exit the tobacco category does not affect the company’s 2014 segment operating profit guidance, 2014 EPS guidance, or the company’s five-year financial projections provided at its December 18th Analyst Day.The company estimates that it will lose approximately $2 billion in revenues on an annual basis from the tobacco shopper, equating to approximately 17 cents per share. Given the anticipated timing for implementation of this change, the impact to 2014 earnings per share is expected to be in the range of 6 to 9 cents per share. The company has identified incremental opportunities that are expected to offset the profitability impact. This decision more closely aligns the company with its patients, clients and health care providers to improve health outcomes while controlling costs and positions the company for continued growth.

This Press Release is courtesy www.cvscaremark.com

WOONSOCKET, R.I.and CINCINNATI,- CVS Health Corporation (NYSE:CVS) and Omnicare, Inc. (NYSE:OCR) announced today that they have entered into a definitive agreement for CVS Health to acquire Omnicare, the leading provider of pharmacy services to long term care facilities, for $98.00 per share in cash, for a total enterprise value of approximately $12.7 billion, which includes approximately $2.3 billion in debt. In total, Omnicare has approximately 13,000 employees at 160 locations in 47 states across the U.S.

With the acquisition of Omnicare, CVS Health will significantly expand its ability to dispense prescriptions in assisted living and long term care facilities, serving the senior patient population. CVS Health will also expand its presence in the rapidly growing specialty pharmacy business. Omnicare’s complementary specialty pharmacy platform and clinical expertise will augment CVS Health’s capabilities and enable CVS Health to continue to provide innovative and cost-effective solutions to patients and payors.

The boards of directors of both companies have approved the transaction, which is subject to approval by the holders of Omnicare’s common stock, as well as other customary closing conditions, including applicable regulatory approvals. The transaction is expected to close near the end of 2015.

CVS Health expects to achieve significant purchasing and revenue synergies as well as operating efficiencies from this combination. The company expects the transaction to be approximately 20 cents accretive to Adjusted EPS in 2016, its first full year, excluding integration and any one-time transaction costs. It is expected to become increasingly accretive to Adjusted EPS in subsequent years. The company has secured $13 billion in fully committed unsecured bridge financing from Barclays and expects to put in place permanent financing in the form of senior notes and/or term loans prior to the closing of the transaction. CVS Health expects that it will continue to have a solid balance sheet and, with its strong free cash flow, is committed to returning to its targeted leverage ratio of 2.7 times adjusted debt-to-EBITDA.

“The acquisition of Omnicare significantly expands our business, providing CVS Health access into a new pharmacy dispensing channel,” said CVS Health President and CEO Larry Merlo. “It also creates new opportunities for us to extend our high-quality, innovative pharmacy programs to a broader population of seniors and chronic care patients as they transition across the care continuum. We have been impressed by the Omnicare team and what they have created for the patients they serve.”

“We are pleased to have reached this agreement with CVS Health, one of the leading companies in the health care industry, which we believe will allow us to accelerate our mission of enhancing the quality and cost-effectiveness of care for complex patient populations,” said Omnicare President and CEO Nitin Sahney. “This exciting combination is the result of a broad and thorough review of our strategic options. On behalf of the Omnicare team, I’d like to thank our 13,000 employees whose hard work and dedication has enabled Omnicare to become a recognized leader in pharmacy services.”

Given the aging U.S. population, long term care is a growth segment of the health care system. More people are expected to use assisted living facilities and independent living communities in the coming decades, creating a substantial growth opportunity for those companies serving the health care needs of seniors.

In entering this new customer distribution channel, CVS Health will deliver meaningful benefits to consumers, patients, caregivers, and payors by providing highly coordinated clinical pharmacy care across multiple treatment settings from retail to long term care. CVS Health will help improve patient outcomes and provide enhanced continuity of care to patients and caregivers as they transition through the health care system.

CVS Health received investment banking and financial advice from Barclays and Evercore. The company was advised on transaction legal matters by Sullivan & Cromwell LLP and on antitrust matters by Dechert LLP.

BofA Merrill Lynch and Centerview Partners are serving as financial advisors to Omnicare. White & Case LLP is serving as Omnicare’s legal counsel.

About CVS Health
CVS Health (NYSE: CVS) is a pharmacy innovation company helping people on their path to better health. Through its 7,800 retail drugstores, nearly 1,000 walk-in medical clinics, a leading pharmacy benefits manager with more than 70 million plan members, and expanding specialty pharmacy services, the Company enables people, businesses and communities to manage health in more affordable, effective ways. This unique integrated model increases access to quality care, delivers better health outcomes and lowers overall health care costs. Find more information about how CVS Health is shaping the future of health at www.cvshealth.com.

About Omnicare
Omnicare, Inc., a Fortune 500 company based in Cincinnati, Ohio, provides comprehensive pharmaceutical services to patients and providers across the United States. As the market-leader in professional pharmacy, related consulting and data management services for skilled nursing, assisted living and other chronic care institutions, Omnicare leverages its unparalleled clinical insight into the geriatric market along with some of the industry’s most innovative technological capabilities to the benefit of its long-term care customers. Omnicare also provides specialty pharmacy and key commercialization services for the bio-pharmaceutical industry through its Specialty Care Group. For more information, visit www.omnicare.com.

Woonsocket, RI and Minneapolis, MN, June 15, 2015 – CVS Health Corporation (NYSE:CVS) and Target Corporation (NYSE:TGT) announced today that they have entered into a definitive agreement for CVS Health to acquire Target’s pharmacy and clinic businesses for approximately $1.9 billion. Through this agreement, CVS Health will acquire Target’s more than 1,660 pharmacies across 47 states and operate them through a store-within-a-store format, branded as CVS/pharmacy. In addition, a CVS/pharmacy will be included in all new Target stores that offer pharmacy services. Target’s nearly 80 clinic locations will be rebranded as MinuteClinic, and CVS Health will open up to 20 new clinics in Target stores within three years of the close of the transaction. The new clinics will be part of CVS/minuteclinic’s plan to operate 1,500 clinics by 2017. In addition, CVS Health and Target plan to develop five to 10 small, flexible format stores over a two-year period following the deal close, which will each be branded as TargetExpress and include a CVS/pharmacy.

This strategic relationship brings together two leading retailers with complementary strengths, brands and cultures to enhance the health care experience for Target guests while expanding CVS Health’s retail presence in new markets, such as Seattle, Denver, Portland and Salt Lake City. The transaction enables CVS Health to reach more patients, adding a new retail channel for its offerings, and expanding convenient options for consumers. Given CVS Health’s proven success in growing its business, the relationship is expected to benefit Target’s long-term traffic and sales growth. It also enables Target to strengthen its focus on wellness as a signature category. Moving forward, enhanced efforts by Target will center on continuing to deliver products and experiences to help guests eat well, be active and find natural and clean label products.

“This strategic relationship with Target supports the highly complementary customer base, brand and culture we share,” said Larry Merlo, CVS Health President and CEO. “When we introduced the new name for our company, CVS Health, we began a new era of growth with a broader health care focus and an appreciation of the rise of health care consumerism with consumer choice and accountability growing. This relationship with Target will provide consumers with expanded options and access to our unique health care services that lead to better health outcomes and lower overall health care costs.”

“At Target, we’ve talked a lot about the evolving preferences of our guests and this partnership demonstrates that we’re committed to putting them at the forefront of everything we do,” said Brian Cornell, Target Chairman and CEO. “By partnering with CVS Health, we will offer our guests industry leading health care services, and at the same time, sharpen our focus on elevating the way we deliver wellness products and experiences to our guests.”

Following completion of the transaction, Target guests will have access to CVS Health’s leading pharmacy care programs and medical clinic services. Pharmacy programs, including Pharmacy Advisor, Specialty Connect and Maintenance Choice, will help consumers achieve better medication adherence through both improved convenience as well as enhanced pharmacy care counseling. CVS Health has also committed to having a low-cost generic drug option available to Target’s cash-paying guests. In addition, with MinuteClinic at Target locations, Target guests will have enhanced access to high-quality affordable medical care. CVS Health customers will gain the option of an expanded, one-stop Target shopping experience, including apparel, home, fresh food and more, when seeking health care services.

The strategic relationship also unlocks future joint development opportunities. Together, Target and CVS Health will carefully evaluate and select locations best-suited for new small format Target stores with a CVS/pharmacy inside. Additionally, Target and CVS Health will explore innovative, new market offerings that have the potential to generate strong returns on investment and offer long-term benefits for customers and communities.

“We operate in a rapidly changing health care and regulatory environment,” added CVS Health’s Merlo. “This requires companies like CVS Health to continually innovate, providing additional points of access, lowering costs and improving quality for both consumers and payors.”

This acquisition is consistent with each company’s stated goals of investing in core businesses that help drive growth.

CVS Health expects this transaction to generate significant sales and prescription volumes upon closing, and to generate significant operating profit over the long term. The company will finance the transaction with additional debt. In combination with CVS Health’s planned acquisition of Omnicare, this transaction will increase the company’s Adjusted Debt to EBITDA leverage ratio to approximately 3.2x. In support of reaching its leverage target of 2.7x, CVS Health is reducing its share repurchase guidance for 2015 by $1 billion, from $6 billion to $5 billion. This reduction in share repurchases reduces the company’s 2015 Adjusted Earnings Per Share guidance by approximately one cent per share and will lower 2016 Adjusted Earnings Per Share by approximately 4 cents per share.

The timing of closing the transaction is uncertain; assuming it closes near the end of the year, the transaction is expected to be approximately 6 cents dilutive to CVS Health’s Adjusted Earnings Per Share in 2016. This includes the dilutive impact to 2016 from the lower 2015 share repurchase of approximately 4 cents per share as well as financing costs of approximately 5 cents per share; it excludes integration costs and any transaction or one-time costs associated with the deal. On the same basis, the transaction is expected to be approximately 10 cents accretive to CVS Health’s Adjusted Earnings Per Share in 2017, and at least 12 cents accretive to CVS Health’s Adjusted Earnings Per Share in 2018 and beyond.

This transaction will allow Target to continue offering this traffic-driving business in its stores and deliver a differentiated experience in support of its wellness efforts. Target’s after-tax net proceeds from the transaction are expected to be approximately $1.2 billion, which Target expects to deploy in support of its long-standing capital priorities, including share repurchase. The transaction is expected to benefit Target’s Segment EBITDA and EBIT margins post-close, is expected to be accretive to Target’s EPS immediately following the deal close, and is expected to add half a percentage point or more to Target’s return on invested capital over time.

The transaction is subject to customary closing conditions, including necessary regulatory clearance. In-store changes will be rolled out over a period of several months thereafter, as CVS Health and Target work to ensure the smoothest possible transition for all pharmacy and clinic patients. CVS Health is committing to offering the approximately 14,000 in-store Target health care professionals comparable positions with CVS Health as part of the transition. Also following the deal closing, Target will further evaluate the business impact and related support needs at its headquarters locations.

About CVS Health
CVS Health (NYSE: CVS) is a pharmacy innovation company helping people on their path to better health. Through its 7,800 retail drugstores, nearly 1,000 walk-in medical clinics, a leading pharmacy benefits manager with more than 70 million plan members, and expanding specialty pharmacy services, the Company enables people, businesses and communities to manage health in more affordable, effective ways. This unique integrated model increases access to quality care, delivers better health outcomes and lowers overall health care costs. Find more information about how CVS Health is shaping the future of health at www.cvshealth.com.

About Target
Minneapolis-based Target Corporation (NYSE: TGT) serves guests at 1,795 stores and at Target.com. Since 1946, Target has given 5 percent of its profit to communities, that giving equals more than $4 million a week. For more information, visit Target.com/Pressroom. For a behind-the-scenes look at Target, visit Target.com/abullseyeview or follow @TargetNews on Twitter.

WOONSOCKET, R.I., Jan. 19, 2022 /PRNewswire/ — CVS Health (NYSE: CVS) today announced a collaboration with Uber Health, Uber’s healthcare arm, to provide critical transportation support at no cost to people who need it most when seeking access to medical care, work or educational programs.

The relationship is part of Health Zones, CVS Health’s new initiative that provides concentrated local investments designed to reduce health disparities and advance health equity in high-risk communities across the country. Health Zones is an integrated approach to addressing six key social determinants of health: housing, education, access to food, labor, transportation, and health care access. The Health Zones initiative is now active in five markets nationwide: Atlanta, GA; Columbus, OH; Fresno, CA; Hartford, CT; and Phoenix, AZ with plans to expand into more cities later this year. Working with trusted national and local partners, CVS Health is addressing community health care needs, ensuring at-risk communities have access to resources and opportunities that can help them thrive.

CVS Health and Uber Health will help eliminate a critical barrier to care and overall well-being – transportation – which can limit a person’s ability to receive medical care, to get to work or to job trainings and can ultimately lead to adverse health outcomes. Rides with Uber Health will be available to a target population living in three of the five Health Zones: Atlanta, GA; Columbus, OH; and Hartford, CT with plans to enter additional cities later this year.

“Our Health Zones initiative allows us to make a real impact on the health of communities across the country by working closely with organizations that share our commitment to addressing social determinants of health,” said Eileen Howard Boone, Senior Vice President of Corporate Social Responsibility & Philanthropy and Chief Sustainability Officer, CVS Health. “With the Uber Health platform, we’ll provide critical transportation to people within communities who need it most, giving them access to health care services so they can live healthier lives and to jobs and educational programs that can help them reach their full potential.”

“We’ve long known that access to reliable transportation can help address critical gaps in care that often disproportionately affect vulnerable communities. With the past two years of the pandemic only further highlighting today’s health inequities, it’s more important than ever for communities to have the tools they need to bridge care gaps and achieve better patient and population health outcomes,” said Caitlin Donovan, Global Head of Uber Health. “Uber Health is proud to be a part of CVS Health’s new Health Zones initiative and encourages community organizations to address transportation as a key social determinant of health, while improving health outcomes in a scalable way.”

For Uber Health, the relationship with CVS Health is a natural extension of its broader commitment to improving population health care management, so more people can achieve and maintain healthy lifestyles. Its HIPAA-supported solution is utilized by more than 2,000 health care organizations across the U.S.

Health Zones is part of CVS Health’s overall commitment to advance health equity in America. In 2021, CVS Health invested $185 million in affordable housing nationwide and $1.3 billion over the past 20 years. Through these investments, CVS Health has been able to provide underserved communities with quality housing, economic support, and educational training opportunities based on the unique needs of the population.

CVS Health continues to help ensure equitable access to COVID-19 testing and vaccinations across the country. Approximately 40 percent of vaccines have been provided to underserved communities and more than 50 percent of CVS Health’s testing sites have also supported these communities.

To learn more about CVS Health’s new Health Zones initiative and the collaboration with Uber Health, please visit www.CVSHealth.com/HealthZones.

About CVS Health
CVS Health is the leading health solutions company, delivering care like no one else can. We reach more people and improve the health of communities across America through our local presence, digital channels and approximately 300,000 dedicated colleagues – including more than 40,000 physicians, pharmacists, nurses, and nurse practitioners. Wherever and whenever people need us, we help them with their health – whether that’s managing chronic diseases, staying compliant with their medications, or accessing affordable health and wellness services in the most convenient ways. We help people navigate the health care system – and their personal health care – by improving access, lowering costs and being a trusted partner for every meaningful moment of health. And we do it all with heart, each and every day. Learn more at www.cvshealth.com.

About Uber Health
Since 2018, Uber Health’s HIPAA-supported solution has become the logistics platform of choice for healthcare organizations focused on population health management. From non-emergency medical transportation, nutritional meals to prescription delivery, Uber Health can help connect millions to the care they need. Over 2,000 healthcare organizations like ALC Solutions, Cerner, Boston Medical Center, and ModivCare trust Uber Health to provide access to stress-free transportation for those they care for. By tapping into Uber’s logistics expertise, Uber Health’s API is able to facilitate everything from mobility solutions to critical deliveries, streamlining population health management and supporting better patient outcomes. For more information, visit uberhealth.com.

Media contact
Eva Pereira
781-686-4200
PereiraE1@cvshealth.com

SOURCE CVS Health

WOONSOCKET, R.I., – CVS Health (NYSE: CVS) announced today it has entered into new clinical affiliations with Sutter Health in California, Millennium Physician Group in Florida, Bryan Health Connect in Nebraska and Mount Kisco Medical Group, PC in New York. These affiliations will help enhance access to high-quality, affordable health care services for patients. Through these clinical affiliations, CVS Health will provide prescription and visit information to the participating health care organizations by enabling communication between our secured electronic health record (EHR) systems, which will help enhance clinical care for patients served by the partnering organizations. In addition, patients will continue to have access to clinical support, medication counseling, chronic disease monitoring and wellness programs at CVS/pharmacy stores and MinuteClinic, the retail medical clinic of CVS Health.

“In this era of health care reform, we are pleased to work with these health care organizations to develop collaborative programs that enhance access to patient care, improve health outcomes and lower health care costs in the communities they serve,” said Troyen A. Brennan, MD, Chief Medical Officer, CVS Health. “By allowing our electronic health records and information systems to communicate and share important information about the patients we collectively serve, we will have a more comprehensive view of our patients, which can aid in health care decision making and help ensure patients adhere to important medications for chronic diseases.”

CVS/pharmacy currently has more than 7,800 retail pharmacy locations across the U.S. where CVS pharmacists provide counseling to patients to help them be adherent to their chronic disease medications. In addition, MinuteClinic also plays an important role by providing patients with timely, affordable and high-quality walk-in health care. There are nearly 1,000 MinuteClinic walk-in medical clinics available at CVS/pharmacy retail stores. MinuteClinic locations are open seven days a week, offering evening hours with no appointment necessary and most health insurance is accepted. The clinics are staffed by nurse practitioners and physician assistants who provide treatment for common family illnesses and administer wellness and prevention services, including health-condition monitoring for patients with chronic diseases.

Affiliates’ health care providers will receive data on interventions conducted by CVS pharmacists to improve medication adherence for their patients. The affiliation also encourages collaboration between the health care providers and MinuteClinic providers to improve coordination of care for patients seen at MinuteClinic locations. Through this collaboration, the affiliate organizations and MinuteClinic practitioners will also work together on planning strategies around chronic care and wellness. If more comprehensive care is needed, patients can follow up with their primary care provider and have access to the services at the health care provider as appropriate. For those patients who do not have regular access to health care, MinuteClinic provides information to help patients in finding a primary care physician and a greater opportunity for continuity of health care services.

MinuteClinic, CVS/pharmacy and the participating health care organizations will begin to work toward streamlining and enhancing communication through their EHR systems. This will include the electronic sharing of messages and alerts from CVS/pharmacy to the health care organizations’ physicians regarding medication non-adherence issues. In addition, MinuteClinic will electronically share patient visit summaries with the patient’s primary care physician when they are part of an affiliate organization and with the patient’s consent. MinuteClinic will continue its standard practice of sending patient visit summaries to primary care providers who are not affiliated with one of these participating health care organizations via fax or mail, with patient consent.

The new affiliations announced here bring the total number of clinical collaborations for CVS Health and MinuteClinic to nearly 60 major health systems and health care providers across the country.

About CVS Health
CVS Health (NYSE: CVS) is a pharmacy innovation company helping people on their path to better health. Through its 7,800 retail drugstores, nearly 1,000 walk-in medical clinics, a leading pharmacy benefits manager with more than 70 million plan members, and expanding specialty pharmacy services, the Company enables people, businesses and communities to manage health in more affordable, effective ways. This unique integrated model increases access to quality care, delivers better health outcomes and lowers overall health care costs. Find more information about how CVS Health is shaping the future of health at www.cvshealth.com.

WOONSOCKET, R.I., — CVS Health (NYSE: CVS) announced today it has entered into new clinical affiliations with three leading regional health systems to enhance access to high-quality, affordable health care services for patients. The collaborating health systems include Baptist Health System in Alabama; Community Health Systems (CHS) affiliated hospitals which include Commonwealth Health in Pennsylvania, Northwest Medical Center, including Oro Valley Hospital in Arizona, and Tennova Healthcare in Tennessee; and Premier Health in Ohio. Through these clinical affiliations the patients served by these health systems will continue to have access to clinical support, medication counseling, chronic disease monitoring and wellness programs at CVS/pharmacy stores and MinuteClinic, the retail medical clinic of CVS Health. In addition, CVS Health will provide critical prescription and visit information to the participating health systems through the integration of secured electronic medical record (EMR) systems.

CVS/pharmacy currently has more than 7,700 retail pharmacy locations across the U.S. where CVS pharmacists provide counseling to patients to help them be adherent to their chronic disease medications. Of the total retail pharmacy locations, there are more than 900 MinuteClinic walk-in medical clinics available. MinuteClinic locations are open seven days a week, offering evening hours with no appointment necessary and most health insurance is accepted. The clinics are staffed by nurse practitioners and physician assistants who provide treatment for common family illnesses and administer wellness and prevention services, including health-condition monitoring for patients with chronic diseases.

“We look forward to working with these leading regional health systems to develop collaborative programs that improve patient outcomes, lower costs and help people on their path to better health,” said Troyen A. Brennan, MD, Chief Medical Officer, CVS Health. “Through these clinical affiliations, we will also be integrating our electronic medical records and information systems to enable us to support patients with medication counseling and chronic disease monitoring.”

The health care providers at the participating health systems will receive data on interventions conducted by CVS pharmacists to improve medication adherence for their patients. The affiliation also encourages collaboration between the health care providers and MinuteClinic providers to improve coordination of care for patients seen at MinuteClinic locations. Physicians affiliated with the participating health systems will collaborate with MinuteClinic nurse practitioners to work closely on joint clinical programs and care coordination activities. If more comprehensive care is needed, patients can follow up with their primary care provider and have access to the services at the medical center as appropriate. For those patients who do not have regular access to health care, MinuteClinic provides assistance in finding a primary care physician and a greater opportunity for continuity of health care services.

“Finding cost-effective ways to increase access to care continues to be important, especially in this era of health care reform, and we are pleased to work together with these health care providers to help coordinate comprehensive care for their patients,” said Dr. Brennan. “Many patients rely on their local pharmacist for information and support regarding their prescription medications and these affiliations enable CVS pharmacists to help improve affiliated health care providers’ patient health outcomes through better medication adherence. MinuteClinic also plays an important role by providing patients with timely, affordable and high-quality walk-in health care.”

MinuteClinic, CVS/pharmacy and the participating health systems will begin to work toward integrating EMR systems to streamline and enhance communication. This integration will include the electronic sharing of messages and alerts from CVS/pharmacy to the health systems’ physicians regarding medication non-adherence issues. In addition, MinuteClinic will electronically share patient visit summaries with the patient’s primary care physician when they are part of a health system affiliate and with the patient’s consent. MinuteClinic will continue its standard practice of sending patient visit summaries to primary care providers who are not affiliated with one of these participating health systems via fax or mail, with patient consent.

The new clinical affiliations announced here bring the total number of health system and health care provider affiliations for CVS Health and MinuteClinic to more than 40 major health systems and health care providers across the country.

About CVS Health
CVS Health (NYSE: CVS) is a pharmacy innovation company helping people on their path to better health. Through our 7,700 retail pharmacies, 900 walk-in medical clinics, a leading pharmacy benefits manager with nearly 65 million plan members, and expanding specialty pharmacy services, we enable people, businesses and communities to manage health in more affordable, effective ways. This unique integrated model increases access to quality care, delivers better health outcomes and lowers overall health care costs. Find more information about how CVS Health is shaping the future of health at www.cvshealth.com.

WOONSOCKET, R.I., April 30, 2021 /PRNewswire/ — CVS Health (NYSE: CVS) announced today it has launched an expansion of Project Health, the company’s no-cost, community-based screening program, which helps people without regular access to health care understand their risk for chronic conditions and connect to free or low-cost providers and services to support their unique health care needs.

As the company begins its 16th year of Project Health events, it will focus on an expansion into 14 new metro markets and the addition of four new mobile units to help bring these health screenings closer to areas of significant need. Between April and December, CVS Health anticipates hosting more than 1,700 Project Health screening events in a total of 32 metro markets across the country. The new metro areas where Project Health will expand include Birmingham, AL; Phoenix, AZ; Jacksonville, Orlando and Tallahassee, FL; Baton Rouge and New Orleans, LA; Jackson, MS; Charlotte, NC; Cleveland, OH; Charleston and Columbia, SC; and Knoxville and Memphis, TN.

“At the heart of our purpose of helping people on their path to better health is our commitment to breaking down the barriers for people to access quality and affordable health care, and we started Project Health to help address these barriers in at-risk communities,” said Eileen Howard Boone, SVP, Corporate Social Responsibility and Philanthropy, CVS Health. “Each year as we choose Project Health locations, we select sites where we can make the most impact at the local level.”

Last year, CVS Health made a nearly $600 million commitment to invest in initiatives that address inequality faced by Black people and other disenfranchised communities. This expansion of Project Health is the latest in the company’s efforts to address social determinants of health that exist alongside racial and economic inequities.

“Our efforts to address social justice and equity are focused in areas where we can have the greatest impact as a leader in health,” said Kyu Rhee, SVP and Chief Medical Officer, CVS Health. “Over the last 15 years, Project Health has been extremely successful in connecting people to the health information and follow-up care they need to address the chronic conditions in many health disparity populations. As we expand the program this year, we will be able to dramatically increase our impact, ability to reduce health disparities and promote health equity.”

Through Project Health, the company hosts events at CVS Pharmacy locations offering free biometric screenings including blood pressure, cholesterol, glucose level and body mass index to detect early risks of chronic conditions such as diabetes, hypertension and heart disease before they become life-threatening. Following these screenings, participants have the opportunity to meet with a nurse practitioner who can provide referrals for treatment and advice on follow-up care, which is particularly important given that some people have delayed or put off primary care during the COVID-19 pandemic. Project Health events are prioritizing the safety of employees, customers and patients by taking the necessary steps to follow CDC COVID-19 guidelines.

Since its inception in 2006, Project Health has delivered more than $134 million in free health care services to over one million Americans in diverse communities with large numbers of uninsured or underinsured people.

Patients can visit cvs.com/project-health to learn more about these events and how they can safely prioritize their health by receiving a no-cost screening.

About CVS Health
We are a diversified health services company with more than 300,000 employees united around a common purpose of helping people on their path to better health. In an increasingly connected and digital world, we are meeting people wherever they are and changing health care to meet their needs. Built on a foundation of unmatched community presence, our diversified model makes us an integral part of people’s everyday health. From our innovative new services at HealthHUBTM locations, to transformative programs that help manage chronic conditions, we are making health care more accessible, more affordable and simply better. Learn more about how we’re transforming health at www.cvshealth.com.

Media Contact:
Courtney Tavener
401-712-3698
Courtney.Tavener@CVSHealth.com

SOURCE CVS Health

Related Links
www.cvshealth.com

WOONSOCKET, R.I., New research conducted by CVS Caremark (NYSE: CVS) and Brigham and Women’s Hospital published online today in Health Affairs, identifies five key features of popular Value-Based Insurance Design (VBID) plans that are associated with the greatest impact on medication adherence. The study, which will also appear in the journal’s March issue, was funded by a grant from the Robert Wood Johnson Foundation’s Changes in Health Care Financing and Organization (HCFO) Initiative.

A variety of pharmacy benefit structures- including copayments, co-insurance and deductibles- help payors contain health care spending by encouraging patients to actively consider and bear the cost of prescription medications. VBID plans take a different approach by reducing the cost to the patient for medications that offer higher clinical benefit with the intent that increased medication use would improve health outcomes and reduce overall health care spending. For example, patients in a VBID plan who have a chronic disease such as high blood pressure may have their out-of-pocket costs (e.g., copay) significantly reduced or eliminated for essential medications to treat their condition.

“For the first time, this research offers high-quality, empirical data on the VBID plan features that appear most effective for stimulating greater medication adherence,” said Niteesh Choudhry, MD, PhD, associate physician, Division of Pharmacoepidemiology and Pharmacoeconomics, Brigham and Women’s Hospital and associate professor, Harvard Medical School and the lead author of the study. “The results show that several specific features can improve adherence from between two to five percentage points and this information can help influence how future copayment reduction plans are structured for optimal benefit.”

The researchers evaluated 76 VBID plans provided by CVS Caremark to 33 unique plan sponsors and involving more than 274,000 patients. Based on the analysis, five key features were found to have a greater impact on adherence. These included:

More generous VBID plans (e.g., those plans that had no cost-sharing for generic drugs and low monthly copayments of
Plans that targeted high-risk patients,
Plans that had concurrent wellness programs,
Plans that did not have concurrent disease management programs, and
Plans that made the benefit available only by mail order, offering 90 day prescriptions.
“VBID plans have been popular with employers and health plans as a way to use financial incentives and other methods to encourage medication adherence, improve health outcomes and reduce overall health care costs,” said William H. Shrank, MD, MSHS, senior vice president and Chief Scientific Officer of CVS Caremark, and a study co-author. “In order to optimize the benefits of VBID plans, these findings encourage more generous coverage for generics, greater use of 90-day prescriptions, more careful intervention targeting and expansion of wellness programs, all of which are active initiatives at CVS Caremark.”

CVS Caremark is focused on developing programs to help improve medication adherence. The study described here helps improve the industry’s overall understanding of medication adherence and enables CVS Caremark to develop more targeted, measureable programs to address the underlying behaviors that contribute to nonadherence. CVS Caremark plans to use these research results along with other key information to identify, develop and pilot breakthrough interventions that will help improve medication adherence for the patients we support. The company is currently evaluating and piloting a number of interventions ranging from model development and prediction of adherence behaviors; to the use of medication reminder devices to help combat forgetfulness and improved labeling to address health literacy difficulties; to digital interventions that engage patients to encourage adherence.

CVS Caremark has been supporting a multi-year research collaboration with Brigham and Women’s Hospital to better understand patient behavior, particularly around medication adherence. Annual excess health care costs due to medication non-adherence in the U.S. have been estimated to be as much as $290 billion.

About CVS Caremark
CVS Caremarkis dedicated to helping people on their path to better health as the largest integrated pharmacy company inthe United States. Through the company’s more than 7,600 CVS/pharmacy stores; its leading pharmacy benefit manager serving more than 60 million plan members; and its retail health clinic system, the largest in the nation with more than 800 MinuteClinic locations, it is a market leader in mail order, retail and specialty pharmacy, retail clinics, and Medicare Part D Prescription Drug Plans. As a pharmacy innovation company with an unmatched breadth of capabilities,CVS Caremarkcontinually strives to improve health and lower costs by developing new approaches such as its unique Pharmacy Advisor program that helps people with chronic diseases such as diabetes obtain and stay on their medications.

This news is courtesy of www.cvscaremark.com

WOONSOCKET, R.I.,– A new study by the CVS Health (NYSE: CVS) Research Institute and researchers at the Perelman School of Medicine at the University of Pennsylvania, published today in the New England Journal of Medicine, finds that employer-sponsored smoking cessation programs with financial incentives are associated with higher rates of quitting smoking and sustained abstinence. Findings of the study, conducted among a sample of CVS Health colleagues and their relatives and friends, helped shape an innovative smoking cessation program for CVS Health colleagues that will launch in June 2015.

“More than 50 years after the release of the first Surgeon General’s report on the harmful effects of tobacco, smoking still remains the leading cause of preventable illness and death in the U.S. While as a society, we have made significant strides in curbing rates of smoking, there is still a clear opportunity to make an even greater impact,” said Troyen A. Brennan, MD, MPH, executive vice president and Chief Medical Officer, CVS Health and a study co-author. “As we think about novel approaches to smoking cessation, these findings provide evidence that financial incentives can be a powerful motivator.”

The researchers randomly assigned approximately 2,500 CVS Health colleagues and their family and friends to one of four incentive-based smoking cessation programs or to usual care, which consisted of informational resources and free access to a behavioral-modification program and nicotine-replacement therapy. Across all of the incentive-based programs, participants were eligible for up to $800 for successfully quitting smoking but the programs differed in how incentives were accrued and disbursed. Two of the programs required participants to pay an upfront deposit of $150, which was reimbursed if participants successfully quit smoking. Overall, study participants who enrolled in any of the four incentive-based programs were nearly three times more likely to quit smoking than those who received usual care alone. In addition, although participants assigned to the groups requiring an upfront deposit were more likely to decline participation than those in the pure incentive-based programs, deposit programs led to nearly twice the rate of abstinence from smoking at six months among people who would have accepted either type of program.

“This study is one of the first to compare incentive programs that first require deposits and programs that entail pure rewards to promote healthy behaviors,” added Scott D. Halpern, MD, PhD, Assistant Professor of Medicine, Perelman School of Medicine at the University of Pennsylvania and lead author of the study. “The results are fully consistent with the behavioral theory that people are typically more motivated to avoid losses than to seek gains. Although the need to make monetary deposits deters some people from participating, deposit-requiring incentive programs can produce robust, long-term results in helping to change complex health behaviors.”

As part of CVS Health’s purpose of helping people on their path to better health, CVS Health will launch 700 Good Reasons, an innovative smoking cessation program for its colleagues who smoke or use tobacco of any kind. Set to launch next month, the program was developed based on key learnings and insights gained from this new research in order to create an incentive program that would both encourage participation and result in sustained success in quitting smoking. Program participants are required to pay a $50 deposit and can earn up to $700 as well as a refund of their full deposit if they commit to quit and are successful. The financial incentives will be paid to participating employees who test tobacco-free at six and 12 months. In addition, those enrolled will also be encouraged to participate in CVS/minuteclinic’s Start to Stop® smoking cessation program which offers a personalized quit plan, nicotine replacement therapy and support to help stay on track.

“Last year, we made a commitment as a company to be tobacco-free as we strive to fulfill our purpose of helping people on their path to better health and that includes our colleagues,” said Lisa Bisaccia, executive vice president and Chief Human Resources Officer, CVS Health. “The research we conducted with the University of Pennsylvania provided us with important information about what can motivate and help our colleagues stop smoking. We are excited to offer this innovative program to our colleagues who want to quit smoking as we foster a healthy workplace and workforce.”

CVS Health stopped selling tobacco products in all CVS/pharmacy locations in September 2014 to support the health and well-being of its patients and customers.

The CVS Health Research Institute is focused on contributing to the body of scientific knowledge related to pharmacy and health care through research collaborations with external academic institutions, participation in federally-funded research, analysis and sharing of CVS Health data sources and coordination of pilot programs and initiatives. CVS Health Research Institute findings support a continuous quality improvement environment, which encourages product innovation and development to benefit CVS Health patients, clients and their members.

The study was also supported by a grant from the National Cancer Institute (CA159932) and a grant from the National Institute on Aging (AG036592).

About CVS Health
CVS Health (NYSE: CVS) is a pharmacy innovation company helping people on their path to better health. Through its 7,800 retail drugstores, nearly 1,000 walk-in medical clinics, a leading pharmacy benefits manager with more than 70 million plan members, and expanding specialty pharmacy services, the Company enables people, businesses and communities to manage health in more affordable, effective ways. This unique integrated model increases access to quality care, delivers better health outcomes and lowers overall health care costs. Find more information about how CVS Health is shaping the future of health at www.cvshealth.com.

There has been important progress made in the global fight against Ebola but a scaling-up in the overall response remains necessary if the deadly outbreak is to be fully stopped, top United Nations officials told the General Assembly today as they cautioned against complacency in tackling the disease.

Addressing an informal briefing the Assembly on the international community’s Ebola response to the outbreak, Anthony Banbury, the head of the UN emergency health mission tasked with coordinating the effort, known as UNMEER, drew particular attention to the “grim milestone” of more than 5,000 confirmed deaths from the disease, “with the real numbers likely to be much greater.”

He also observed that during his recent trips to frontline countries in hard-hit West Africa, the respective Governments had repeatedly stressed the devastating impact the outbreak has had on every aspect of their societies, injecting fear into communities, “upending their way of life” far beyond the “human toll” ¬– leaving numerous orphans in its wake, as well as skyrocketing food prices, school closures, empty markets and collapsing Government revenues.

At the same time, he underlined that “many good things” are also happening, he said, noting first and foremost that some of the early predictions regarding the sustained exponential increase in victims had not materialized.

Indeed, there have been “significant improvements” in many of the dramatically hit areas, such as Monrovia, the capital of Liberia, as well as “tremendous progress” towards the stated UN goal of managing and treating 70 per cent of Ebola cases and making safe 70 per cent of burials by 1 December. The percentages, he explained, were now 55 and 80, respectively, although there were still many unknown and unreported cases.

Community-level action is one of the main reasons for the progress, Mr. Banbury continued, praising “those local communities that have taken action, that have changed their behaviour in order to protect themselves their members, and they deserve a tremendous amount of credit.”

In addition, national-led responses, in coordination with international partners, were also making a difference, he continued, noting that the Governments of Liberia, Sierra Leone and Guinea are taking a serious leadership role in driving the response, built around strengthened Ebola treatment facilities, contact tracing and diagnostic capabilities, safer burials, and social mobilization.

The UNMEER chief also praised his Mission’s nimble approach to tackling the challenges in West Africa and pointed out that the UN, overall, has responded to Ebola in an “unprecedented way across bureaucratic barriers in record time” – a feat, he said, that everyone “can rightly be proud of.”

Yet he also voiced apprehension over the tasks that lay ahead, confessing that he feared he had “not done enough and that collectively we must do more and do it faster.”

“Ebola is a fearsome enemy and we will not win by chasing it. We must get ahead of it,” Mr. Banbury continued. “We need more staff to be deployed to the districts where the disease is. In terms of the broader response, we need more Ebola treatment facilities, more community care centres, more partners on the ground to staff these centres. We need greater mobility for the teams. And we need money to pay for it all.”

At a media stakeout following the briefing, Mr. Banbury reiterated his point that the UN strategy against Ebola was “working” but that the principal challenge facing the response efforts was that the disease had spread so much geographically.

“We need a much greater geographic dispersal and much faster mobility,” he told reporters. “This is happening now thanks to mobilization of resources but we need to do more and do it faster.”

Echoing Mr. Banbury’s call for a scaled-up, agile response to the outbreak, the Secretary-General’s Special Envoy on Ebola, Dr. David Nabarro, told the General Assembly he was “humbled” by the efforts made in combatting the disease and reiterated his claim that Ebola remained one of the most troubling challenges that the world could face.

He cited the positive efforts made by local communities in changing the way they live and behave to reduce their likelihood of contracting the disease and said he was “impressed” by the “unprecedented” global response coalition which was developing and functioning as a joint community.

“The long-term is now,” he concluded, as he called on the international community to accelerate its response efforts. “Let us continue to provide the maximum possible support to the governments.”

Opening an informal briefing, UN General Assembly President, Sam Kutesa, confirmed the “important improvements” made on the ground following recent frontline reports from Guinea and Liberia suggesting significant decreases in infection rates. But, he warned, while the number of new cases was slowing down, the total number across the region still remained perilously high.

“The resounding message from those in the hardest hit areas is that while we are making encouraging progress in combatting Ebola, we have not yet won the war,” Mr. Kutesa said. “We must do more to ensure that the momentum is sustained and that critical resources reach those in urgent need without delay.”

The UN system has been accelerating its Ebola response, including ramped up on-the-ground medical assistance for local governments in affected areas via UNMEER; providing financial support for the countries hardest hit by the socio-economic consequences of the disease through the World Bank; and monitoring the urgent laboratory testing of an experimental Ebola vaccine which, according to the World Health Organization (WHO), could be distributed across West Africa as early as January 2015.

Nevertheless, the General Assembly President explained that the Ebola epidemic was “far from contained” and urged the international community to “stay vigilant and committed to stopping this scourge.”

Susanna Malcorra, Secretary-General Ban Ki-moon’s Chef de Cabinet, agreed as she conveyed Mr. Ban’s appreciation to Member States for their “strong response” to his appeal for increased financial, technical and human support.

Speaking on behalf of the Secretary-General, who is currently on official visit to Southeast Asia, Ms. Malcorra noted, however, that Ebola presented a stark challenge for the international community as it is “an elusive disease,” constantly moving, never standing still in any one geographic location. A comprehensive response, she said, would require responders to adjust and adapt to the shifting reality on the ground.

The elusive nature of the disease, in fact, remains one of Ebola’s most insidious characteristics, as it risks slipping away from the grip of health workers and responders labouring in the most affected districts and flaring up again in neighbouring areas and countries.

In its latest situation report on the Ebola response, the UN World Health Organization (WHO) described a “mixed picture” on the ground with case incidences no longer increasing nationally in Guinea and Liberia while “steep increases persist in Sierra Leone.” In addition, the WHO notes, there have been four reported confirmed and probable cases and four deaths in Mali.

The Department of Health and Human Services today released the draft Trusted Exchange Framework, a significant step towards achieving interoperability, as required by the 21st Century Cures Act of 2016.

The draft Trusted Exchange Framework, issued by HHS’ Office of the National Coordinator for Health Information Technology (ONC), advances Congress’ intent that building and maintaining trust is an important core element in ensuring that health information is available where and when it is needed to manage patient health and care.

“The draft Trusted Exchange Framework we issued today reflects the successes and challenges already existing in the exchange of health information and is designed to help guide the nation on its path to interoperability for all,” said Don Rucker, M.D., national coordinator for health information technology. “The principles and direction we released today, combined with the support of providers, existing health information networks, health IT developers, and federal agencies, are designed to help improve patient care, care coordination, and the overall health of the nation.”

The Trusted Exchange Framework proposes policies, procedures, and technical standards necessary to advance the single on-ramp to interoperability requested by Congress. It will be facilitated through ONC in collaboration with a single Recognized Coordinating Entity (RCE) to be selected through a competitive process. The RCE will use the Trust Exchange Framework policies, procedures, technical standards, principles, and goals to develop a single Common Agreement that Qualified Health Information Networks (Qualified HINs) and their participants will voluntarily agree to adopt. Following a 45-day public comment period and refinements to the draft document, a final draft of the combined Trusted Exchange Framework and Common Agreement will be released. The Trusted Exchange Framework and Common Agreement (TEFCA) will be published in the Federal Register in 2018.

ONC will continue to engage with federal partners, such as the Department of Veterans Affairs (VA) and other stakeholders to establish interoperability that allows health information to be used effectively in care and treatment decisions.

“The Department of Veterans Affairs supports ONC’s efforts to create a common “on-ramp” to health information networks that supports widespread interoperability, said Dr. Carolyn Clancy, VA executive in charge. “We look forward to working with all stakeholders to ensure that our veterans’ health information flows and is available when and where it is needed to support seamless care.”

The proposed Trusted Exchange Framework supports ONC’s goals of achieving nationwide interoperability:

Patient Access – Patients must be able to access their health information electronically without any special effort;
Population-level Data Exchange – Providers and payer organizations accountable for managing benefits can receive population level health information allowing them to analyze population health trends, outcomes, and costs; identify at-risk populations; and track progress on quality improvement initiatives; and
Open and Accessible APIs – The health information technology (health IT) community should have open and accessible application programming interfaces (APIs) to encourage entrepreneurial, user-focused innovation to make health information more accessible and to improve electronic health record (EHR) usability.
The draft Trusted Exchange Framework would not prevent existing or new organizations from creating point-to-point or individual agreements between organizations that have a particular business need to exchange information – while preventing potential information blocking – that may be different from those outlined in the proposal.

Today ONC also released a User’s Guide to Understanding the Trusted Exchange Framework and the US Core Data for Interoperability (USCDI) Glide Path to identify a roadmap for broadening the data that can be exchanged via the TEFCA.

“We know that many stakeholders, including healthcare providers, health systems, developers, and existing health information networks have extensive experience in trust agreements and common exchange networks and strongly encourage stakeholders to share that insight with us,” said Rucker.

The period to comment on the draft Trusted Exchange Framework closes on February 20, 2018. Comments can be submitted at exchangeframework@hhs.gov.

POTTERS BAR, England, April 8, 2015 — Mylan N.V. (NASDAQ: MYL) today announced that Mylan has made a proposal to acquire Perrigo Company plc (NYSE: PRGO) in a cash-and-stock transaction that would create a diversified, global pharmaceutical leader with an unmatched commercial and operating platform and a unique, one-of-a-kind profile. The combination of these highly complementary businesses would produce a company with critical mass in specialty brands, generics, over-the-counter (OTC) and nutritional products; a powerful commercial platform with reach across all customer channels; an exceptional high-quality operating platform; and opportunities to generate enhanced growth and deliver significant immediate and long-term value and benefits for shareholders and the other stakeholders of both companies.

Under the terms of the non-binding proposal, which was delivered to Perrigo’s Chairman on April 6, 2015, Perrigo shareholders would receive $205 in a combination of cash and Mylan stock for each Perrigo share, which represents a greater than 25% premium to the Perrigo trading price as of the close of business on Friday, April 3, 2015 (the last trading date prior to the date of Mylan’s proposal), a greater than 29% premium to Perrigo’s sixty-day average share price and a greater than 28% premium to Perrigo’s ninety-day average share price.

Mylan’s Executive Chairman Robert J. Coury commented, “This proposal is the culmination of a number of prior discussions between Mylan and Perrigo about the compelling strategic and financial logic of this combination. This combination would result in meaningful immediate and long-term value creation, and our proposal is designed to deliver that value to shareholders and other stakeholders of both companies. We have great respect for Perrigo’s board and management team and what they have built. We look forward in the weeks ahead to working with them to capitalize on this tremendous opportunity and working together to create a unique leader with a one-of-a-kind profile in our industry.”

The proposal is subject to the pre-condition of confirmatory due diligence, which pre-condition may be waived by Mylan at its discretion. This announcement is not an announcement of a firm intention to make an offer under rule 2.5 of the Irish Takeover Panel Act, 1997, Takeover Rules 2013 and there can be no certainty that an offer will be made, even if the due diligence pre-condition is satisfied or waived. A further statement will be made if and when appropriate.

The full text of the letter delivered to Perrigo by Mylan on April 6, 2015 is included below.

April 6, 2015

Joseph C. Papa
President, Chief Executive Officer and Chairman
Perrigo Company plc
Treasury Building
Lower Grand Canal St.
Dublin 2, Ireland

Dear Joe:

As you and I have discussed on a number of occasions over the past few years, a combination of Mylan and Perrigo offers clear and compelling strategic and financial benefits, has sound industrial logic, and would create a global leader with a unique and one-of-a-kind profile. We have complementary operations across all of our businesses, both from a product and geographic perspective. In an environment where scale and reach are becoming increasingly important, the combination of our companies would result in an unmatched global platform, substantial revenue and operating synergies, and enhanced long-term growth potential, all of which would serve to create significant value for the combined company’s shareholders and other stakeholders.

Based on our many conversations over the years and my knowledge of Perrigo, I have often noted the similarity in the culture and core values of our two companies. We both place paramount emphasis on integrity, respect and responsibility in our commitment to provide the world’s 7 billion people access to the broadest range of affordable, high quality medicine. We also have a common focus on innovation, reliability and excellent customer service. Most importantly, all of our people are dedicated to creating better health for a better world, one person at a time. This shared culture and these common values will be key contributors to a successful integration.

For the foregoing reasons, I am writing on behalf of Mylan to propose a combination of Mylan and Perrigo in a transaction that would deliver to your shareholders significantly greater near-term and long-term value than they could otherwise obtain on a standalone basis. Our proposal is the natural culmination of our prior discussions and reflects our shared vision for the industry. This is the right time for our two companies to move forward together, and Mylan and our Board are firmly committed to making this combination a reality.

Specifically, we propose to offer Perrigo shareholders $205 in a combination of cash and Mylan stock for each Perrigo share, which represents a greater than 25% premium to the Perrigo trading price as of the close of business on Friday, April 3, 2015, a greater than 29% premium to Perrigo’s sixty-day average share price and a greater than 28% premium to Perrigo’s ninety-day average share price.

Our proposal provides a very significant cash payment to Perrigo shareholders. In addition, even with conservative assumptions for what we believe to be significant and meaningful synergies coming from both companies, our proposal provides Perrigo shareholders with an even greater equity value in the combined company than they currently have in Perrigo today.

In addition to the compelling value to shareholders, a combination of Mylan and Perrigo would offer substantial benefits to the other stakeholders of both companies. In particular, the combination would provide a broader variety of opportunities to our employees and increased stability for the communities in which we operate and serve. The position of our creditors and suppliers would be enhanced by the combined company’s scale and significant free cash flows, and patients would receive improved access to affordable, high quality medicine through increased scale across geographies and robust capabilities to drive innovation.

As you and I have acknowledged in our prior discussions, we have no doubt that you and your Board will recognize the compelling logic of this transaction as outlined below:

Highly complementary businesses with strong presence in key developed and emerging markets around the world;
Attractive, diversified portfolio with critical mass across generics, OTC, specialty brands and nutritionals;
Powerful commercial platform with strong reach across multiple channels, giving the combined company an increasingly important strategic advantage in light of the evolving distributor and payor dynamics across geographies;
World-class operating platform, including an unrivaled combined manufacturing platform, renowned supply chain capabilities, vertical integration and global sourcing excellence with the cost advantages and flexibility to be a leading reliable source of high quality products around the world; and
Strong R&D capabilities, including broad technological capabilities across prescription, OTC and nutritionals products, and expertise in complex, difficult-to-formulate products, which would continue to expand our pipeline and drive long-term growth.
Our proposed transaction not only makes compelling strategic sense, it also results in a combined company with a very strong financial profile, including:

Approximately $15.3 billion in 2014 pro forma sales;
Substantial free cash flows driving rapid deleveraging and enhanced reinvestment into the business;
Compelling synergies resulting in operating margin expansion and EPS accretion;
Scope for meaningful revenue synergies given the strength of the combined business, rich pipeline of launches, and opportunities to mean more to our customers across business lines;
A much stronger, larger and more diverse platform to create enhanced and more predictable earnings growth; and
Greater opportunities for continued growth through strategic acquisitions.
Mylan is a seasoned integrator and quality operator, and we have extensive and proven experience in successfully integrating combinations like this one and capturing the significant value we see ahead.

We and our advisors have carefully studied the regulatory aspects of a combination of Mylan and Perrigo, and we are confident that we would be able to structure a transaction that would not pose material impediments to closing.

The Mylan Board would like to offer you the opportunity to serve with me as co-Chairman and as a member of the Mylan Board. In addition, I look forward to discussing with you the possibility of potentially including other Perrigo directors on the Mylan Board.

The Mylan Board believes that continuity of our management team, with its successful track record of execution and proven strategic vision, is critical to the success of the combined company. As such, I will continue to serve as Mylan’s Executive Chairman, Heather Bresch will continue to serve as CEO and Rajiv Malik will continue to serve as President. Our Board also has great respect for your senior management team, and we envision the combined company leveraging the best of our collective management and employee talent. To that end, we are hopeful that, among others at Perrigo, Judy Brown and Todd Kingma would be willing to serve in important roles with the combined company. We also envision important roles in the combined company for members of Marc Coucke’s Omega Pharma management team. We look forward to exploring with you other ways of maximizing the benefits to our shareholders and other stakeholders presented by combining these two very strong management teams.

We have dedicated a full team to the evaluation of Perrigo, including both Mylan management and outside advisors, and have conducted a thorough review of the business and its operations based on publicly available information. In order to finalize our proposal, we would welcome the opportunity to complete customary confirmatory due diligence, which we believe could be completed quickly. We stand ready to begin working with you and your team immediately and are prepared to commit the resources and time required to complete the proposed transaction expeditiously. To that end, we have retained Goldman Sachs as financial advisors and Cravath, Swaine & Moore as legal advisors to assist us in completing this transaction.

This preliminary proposal is a non-binding indication of interest.

We look forward to working together with you to deliver compelling value and benefits to our respective shareholders and other stakeholders.

Very truly yours,

/s/ Robert J. Coury
Robert J. Coury
Executive Chairman

ABOUT MYLAN

Mylan is a global pharmaceutical company committed to setting new standards in healthcare. Working together around the world to provide 7 billion people access to high quality medicine, we innovate to satisfy unmet needs; make reliability and service excellence a habit; do what’s right, not what’s easy; and impact the future through passionate global leadership. We offer a growing portfolio of around 1,400 generic pharmaceuticals and several brand medications. In addition, we offer a wide range of antiretroviral therapies, upon which approximately 40% of HIV/AIDS patients in developing countries depend. We also operate one of the largest active pharmaceutical ingredient manufacturers and currently market products in about 145 countries and territories. Our workforce of approximately 30,000 people is dedicated to creating better health for a better world, one person at a time. Learn more at mylan.com.

GENEVA – The emergence of an Ebola virus disease outbreak in West Africa in 2014 has become a challenge to the 3 countries involved, as the Governments of Guinea, Liberia and Sierra Leone work intensively with WHO and other partners to ramp up a series of measures to control the outbreak.

Since March 2014, more than 600 cases of Ebola and over 390 deaths have been reported in Guinea, Liberia and Sierra Leone. While the number of suspected, probable and confirmed cases and deaths changes rapidly, the outbreak is causing concern among health authorities because the deadly disease is being transmitted in communities and in health-care settings, and it has appeared in cities as well as rural and border areas. The disease, which causes severe haemorrhaging and can kill up to 90% of those infected, is spread by direct contact with the blood and body fluids of infected animals or people.

Teams of experts deployed

WHO, the Global Alert and Response Network (GOARN), and its partners are providing guidance and support and have deployed teams of experts to West African countries and to WHO’s African Regional Office in Brazzaville, Congo.

These experts include:
epidemiologists to work with the countries in surveillance and monitoring of the outbreak;
laboratory experts to support mobile field laboratories for early confirmation of Ebola cases;
clinical management experts to help health facilities treat affected patients;
infection and prevention control experts to help the countries stop community and health-care facility transmission of the virus;
logisticians to dispatch needed equipment and materials; and
social mobilization and risk communications teams to help health officials deliver appropriate messages about how to report, handle, and treat Ebola cases.
WHO to convene regional experts for comprehensive operational response

Recognizing that a coordinated regional response is essential, WHO is convening the leading health authorities from the affected and nearby countries in Accra, Ghana on July 2–3, to agree on a comprehensive operational response to control the Ebola outbreak. A wide range of partners have been invited, and Ministries of Health of Guinea, Liberia, and Sierra Leone will report on their preventive and control measures, contact identification and tracing; case management; infection and prevention control; social mobilization; and situation reports.

The countries are working to bring supportive care to the ill, inform affected communities of recommended practices, trace contacts of infected patients, control infections in health care settings, and taking other measures to control the outbreak. Despite their progress in implementing preventive and control measures, health authorities still face challenges in curbing the spread of the outbreak, and will discuss these at the Accra meeting.

Latest numbers

The latest numbers, which change as cases are discovered, investigated, or discarded, are:

Guinea has reported some 396 cases and 280 deaths
Sierra Leone has 176 cases and 46 deaths
Liberia reports 63 cases and 41 deaths.

This news is courtesy of www.who.org

First results from a small phase 1 trial published today in the New England Journal of Medicine show that a GSK/NIH Ebola candidate vaccine was well-tolerated and produced an immunological response in each of the 20 healthy adult volunteers in the USA who received it.

The candidate vaccine used in the trial conducted by the National Institutes of Health (NIH) was co-developed by the NIH’s National Institute of Allergy and Infectious Diseases (NIAID) and Okairos, a biotechnology company acquired by GSK in 2013. It uses a type of chimpanzee cold virus, known as chimpanzee adenovirus type 3 (ChAd3), as a carrier to deliver genetic material from two strains of the Ebola virus – the Sudan strain and the Zaire strain, which is responsible for the current Ebola outbreak in west Africa. GSK has been working with the NIH to accelerate development of both this bivalent version of the candidate vaccine and a monovalent version targeting only the Zaire strain in response to the current Ebola epidemic.

Commenting on the results, Dr Moncef Slaoui, Chairman of Global Vaccines at GSK said: “We are very encouraged by these positive first trial results showing this type of vaccine has an acceptable safety profile and can produce an immune response against Ebola in humans.

“Working with partners including the NIH, we’re doing all we can to advance development of a candidate vaccine in response to the Ebola crisis in west Africa.

“It’s important to remember that these data are the first piece in the jigsaw and we’re continuing to gather other important information. Over the coming weeks, we will see results from further phase 1 trials which will tell us more about the profile of the monovalent vaccine; most significantly results from a trial in Mali which is assessing its safety and immune response in west African populations.

“If the combined data from these trials are positive, the next phases of the clinical trial programme will begin in early 2015 to see whether the immune response we are seeing in phase 1 actually translates into providing people in affected countries with meaningful protection against Ebola.

“These phase 3 trials will involve the vaccination of thousands of volunteers, including frontline healthcare workers in affected countries, including Liberia and Sierra Leone, and possibly Guinea. If the candidate vaccine is able to protect these healthcare workers as we hope it will, it could significantly contribute to efforts to bring this epidemic under control.”

Next steps
Development of the vaccine candidate is progressing at an unprecedented rate, with further data from ongoing phase 1 trials in the USA, UK, Mali and Switzerland expected by the end of the year.

If trials are successful, the next phases of the clinical trial programme will begin in early 2015 which will involve the vaccination of thousands of frontline healthcare workers in the two of the affected countries – Sierra Leone and Liberia. Further safety studies will also be conducted in west African countries not affected by the current outbreak in adults and children.

GSK continues to work with the WHO, regulators and other stakeholders to determine possible solutions to accelerate the development of the Ebola candidate vaccine with the goal of trying to limit the further spread of the epidemic.

Its potential future use in mass vaccination campaigns will depend on whether WHO, regulators and other stakeholders are satisfied that the vaccine candidate provides protection against Ebola without causing significant side effects and how quickly large quantities of vaccine can be made.

GSK continue to actively explore with relevant organisations and partners all opportunities to accelerate the development of manufacturing at an industrial scale. Additionally, the company is looking at whether use of a booster vaccine may help provide longer-lasting protection.
GSK – one of the world’s leading research-based pharmaceutical and healthcare companies – is committed to improving the quality of human life by enabling people to do more, feel better and live longer. For further information please visit www.gsk.com.

WASHINGTON, Sept. 9, 2021 /PRNewswire/ — September is Suicide Prevention Awareness Month, and the pandemic continues to impact everyone’s mental health in different ways. Anyone can learn the warning signs of suicide risk and do their part to support those who may need help, according to the American College of Emergency Physicians (ACEP).

“Most people think of the physical dangers of COVID, but this pandemic is contributing significantly to mental health challenges, too. Simple steps, like checking in with someone you care about, can mean the world, and spotting the warning signs of a mental health emergency can save a life,” said Mark Rosenberg, DO, MBA, FACEP, president of ACEP.

Everyone experiences stress at some point, but it is time to contact a professional when risk factors lead to changes in behavior or impede daily activities. If there is an immediate health emergency or safety risk, call 911 or visit the closest emergency department. The warning signs of a mental health emergency can include:

Hopelessness
Rage, uncontrolled anger, seeking revenge
Acting reckless or engaging in risky activities
Increased alcohol or drug use
Withdrawal from friends, family, or society
Anxiety, agitation, trouble sleeping or sleeping all the time
Dramatic mood changes
Prolonged isolation, anxiety or grief can be especially challenging for teens or young adults and emergency physicians are seeing an uptick in mental health emergencies during the pandemic.

Depression and anxiety are on the rise and more children and young adults are going to the emergency department for mental health-related emergencies and suicide attempts, according to the Centers for Disease Control and Prevention (CDC). While overall suicide rates dropped in the last year, more of these tragedies are occurring in minority communities that are disproportionately impacted by COVID.

“Many communities have great mental health resources for anyone who is struggling with depression or suicidal thoughts, and I encourage them to reach out before it becomes an emergency,” said Dr. Rosenberg. “But no matter what the crisis, emergency physicians are trained and ready to help.”

Resources for anyone struggling with their mental health include the National Suicide Prevention Lifeline at 1-800-273-TALK (8255). The confidential service is available 24 hours a day, seven days a week. Read more about the ways emergency physicians identify and reduce suicide risks on www.emergencyphysicians.org.

The American College of Emergency Physicians (ACEP) is the national medical society representing emergency medicine. Through continuing education, research, public education and advocacy, ACEP advances emergency care on behalf of its 40,000 emergency physician members, and the more than 150 million Americans they treat on an annual basis. For more information, visit www.acep.org and www.emergencyphysicians.org.

SOURCE American College of Emergency Physicians (ACEP)

CONTACT: Steve Arnoff | sarnoff@acep.org | Twitter @EmergencyDocs

Related Links
www.acep.org

Enrollment in the Health Insurance Marketplace continued to rise in February to a five-month total of 4.2 million.

As in January, the percent of young adults who selected a Marketplace plan was 3 percentage points higher than it was from October through December (27 percent versus 24 percent). Based on enrollment patterns in other health care programs, it is expected that more people will sign up as we get closer to the March 31st deadline.

“Over 4.2 million Americans have signed up for affordable plans through the Marketplace,” said HHS Secretary Kathleen Sebelius. “Now, during this final month of open enrollment our message to the American people is this: you still have time to get covered, but you’ll want to sign up today – the deadline is March 31st.”

Key findings from today’s report include:

More than 4.2 million (4,242,300) people selected Marketplace plans from Oct. 1, 2013, through Mar. 1, 2014, including 1.6 million in the State Based Marketplaces and 2.6 million in the Federally-facilitated Marketplace. About 943,000 people enrolled in the Health Insurance Marketplace plans in the February reporting period, which concluded March 1, 2014.
Of the more than 4.2 million:
55 percent are female and 45 percent are male;
31 percent are age 34 and under;
25 percent are between the ages of 18 and 34;
63 percent selected a Silver plan (up one percentage point over the prior reporting period), while 18 percent selected a Bronze plan (down one point); and
83 percent selected a plan and are eligible to receive Financial Assistance (up one point).
Today’s report details state-by-state information where available. In some states, only partial datasets were available.

The report features cumulative data for the five-month reporting period because some people apply, shop, and select a plan across monthly reporting periods. Enrollment is measured as those who selected a plan.

This news is courtesy of www.hhs.gov

The EU has acted decisively since the early stages of the current Ebola crisis and is today announcing its latest actions in the field of research. Support to research is part of the EU’s response, together with humanitarian aid, expertise, international coordination and longer-term development assistance.

The European Commission is today announcing eight research projects into Ebola that will be funded with a total of €215 million. These projects will develop in particular vaccines and rapid diagnostics tests, which are key to overcoming the current Ebola crisis. In parallel, another project is now on site in Guinea to monitor the ongoing Ebola crisis with the aim to improve preparedness and planning, operational effectiveness of future interventions in case of similar outbreaks or pandemics.

The eight projects working on vaccine and diagnostics are run under the new Ebola+ programme of the Innovative Medicines Initiative (IMI) and funded jointly by the European Commission and the European pharmaceutical industry. €114 million come from Horizon 2020, the EU’s research funding programme, and the remaining €101 million from the pharmaceutical companies involved in the projects[1]. The announcement comes shortly before the start of the World Economic Forum in Davos, where the Ebola crisis is expected to feature high on the agenda.

European Commissioner for Research, Science and Innovation Carlos Moedas said: “There is no vaccine or treatment against Ebola as yet, so we must urgently step up our efforts in Ebola research. With this funding from Horizon 2020 and our industry partners, we are speeding up the development of an Ebola vaccine as well as rapid diagnostic tests to aid heroic health workers. These are the tools we need to defeat Ebola once and for all.”

The projects include partners from around the world (mainly Europe, Africa, and north America) and address the following aspects (see Annex for more details). The topics are among the key priorities set out by the World Health Organization in the current Ebola crisis:

Development of Ebola vaccines (3 projects)
There are currently no licensed vaccines for Ebola. Three projects will advance the development of such vaccines by assessing the safety and efficacy of different vaccine candidates.

Scaling up vaccine manufacture (1 project)
Ebola vaccines can be manufactured in facilities with a higher biosafety rating. This project will establish a platform capable of rapidly producing sufficient quantities of the vaccine, while adhering to stringent quality and safety requirements.
Compliance with vaccine regimens (1 project)
For a vaccine to have a real impact on an outbreak, high levels of vaccination coverage are essential. In addition, for lasting protection, two doses of the vaccine may be needed. The project will raise awareness of vaccination campaigns and aim to secure patient compliance for vaccines that require two doses.

Rapid diagnostic tests (3 projects)
There is currently no fast, reliable test to determine if someone has Ebola or not. Three projects will pave the way for rapid diagnostic tests capable of delivering reliable results in as little as 15 minutes.

In addition to these, the Miracle project (Mobile Laboratory Capacity for the Rapid Assessment of CBRN Threats Located within and outside the EU) has developed a “Biological scenario” which closely mimics the current Ebola crisis situation and its rapid spread in West Africa, and how it can be addressed. This scenario is currently being implemented in real life operational conditions: An in-field laboratory in the immediate vicinity of an Ebola treatment centre located in the outskirt of Nzere Kore, Guinea, close to the borders of Liberia, Ivory Coast and Sierra Leone. In addition to helping identify Ebola patients quickly, this laboratory will also support new clinical research into one of the most promising drugs for the treatment of Ebola patients. Lessons learned from this deployment will also help refine the analysis of gaps, technological or logistical improvements and missing technologies for mobile laboratories.

To reinforce EU efforts to help fight Ebola in rural communities of Guinea, under the leadership of the Commission, the European Centre for Disease Prevention and Control is deploying in the next few days four teams of French-speaking epidemiologists to support surveillance and response at community level.

Background
The European Commission has already mobilised €24.4 million from Horizon 2020, the EU’s framework programme for research and innovation, that will fund five projects ranging from large-scale clinical trials to tests of existing and new Ebola compound treatments (IP/14/1194).

It also worked with the industry partners within IMI to launch the Ebola+ programme, a multi-million euro programme on Ebola and related diseases such as Marburg haemorrhagic fever, in November 2014 (IP/14/1462). The eight projects announced today were selected following the first call for proposals under this programme.

IMI is a partnership between the EU and the European pharmaceutical industry, represented by the European Federation of Pharmaceutical Industries and Associations (EFPIA), to speed up the development of medicines. IMI was launched in 2007 and had a budget of €2 billion in its first phase until 2013. IMI2 has a budget of €3.3 billion for the period 2014-2024. Half of the funding comes from the EU, the other half from large companies, mostly from the pharmaceutical sector. These do not receive any EU funding, but contribute to the projects ‘in kind’, for example by donating their researchers’ time or providing access to research facilities or resources.

The EU is also helping to fight infectious diseases in sub-Saharan Africa, including Ebola, within the European and Developing Countries Clinical Trials Partnership programme (EDCTP2). This partnership works with a budget of €2 billion over the next ten years, with nearly €700 million coming from Horizon2020 (IP/14/2273).

The Miracle project operates with a budget of €1.4 million, co-funded by the Security research programme of the European Commission. The project is coordinated by the Universite Catholique de Louvain and runs from 1 December 2013 to 31 May 2015.

GENEVA, Switzerland, — Since the Every Newborn Action Plan (ENAP) was endorsed at the World Health Assembly one year ago, 15 of the 18 countries with some of the highest burden of maternal and newborn mortality have taken steps to improve care for mothers and their newborns.

Governments’ commitment to ENAP’s framework is a stride forward. It sets a clear direction for government actions to ensure mothers and their babies survive and thrive following childbirth and the fragile first month, and lays out mortality and coverage of care targets for countries to meet by 2035.

According to the ENAP Progress Report released today, four countries – Bangladesh, India, Indonesia and Kenya – have developed specific action plans, and a further six countries – China, Guinea Bissau, Nigeria, Pakistan, Sierra Leone and Zimbabwe – are in the process of preparing specific action plans. An additional three countries – Chad, Democratic Republic of Congo and Mali – have strengthened newborn components within existing plans for Reproductive, Maternal, Newborn, Child and Adolescent Health (RMNCAH). Work is in progress in Ethiopia and Lesotho to strengthen the newborn component within existing plans.

Also launching today, Strategies toward Ending Preventable Maternal Mortality (EPMM) calls for eliminating inequity in access, quality and outcomes of care within and between countries that lead to wide disparities in maternal and neonatal mortality. EPMM proposes a human rights-based approach to maternal and newborn healthcare, and expands the focus to address the shifting patterns of causes of maternal death in countries, as well as the systemic social, political and economic determinants of health and survival that are associated with high rates of maternal mortality. Both the ENAP and EPMM strategies aim to improve the quality of maternal and newborn care, to reach every woman and newborn with universal coverage, and to strengthen measurement capacity and count every death to drive improvement and accountability.

EPMM aims to address maternal and newborn mortality over the continuum of care, whilst the Every Newborn Action Plan takes on these critical issues by using more immediate tools.

The combined strategic approaches for ending preventable maternal and newborn deaths and stillbirths under Every Woman Every Child promote successful partnership initiatives and country leadership that can lead to real change for families, communities and societies across the globe.

“Countries and other global stakeholders have come together to ensure that sound strategies are available to end preventable maternal and newborn deaths within a generation, and to bridge the equity gap so that all mothers and their newborns, especially those who are voiceless and vulnerable, have their right to health upheld. It is our collective responsibility to ensure that everyone can survive and thrive. These strategies inform the update of the UN Global Strategy for Women’s, Children’s and Adolescents’ Health, highlighting the need for evidence in order to drive this critical agenda forward.” said Dr. Flavia Bustreo, WHO Assistant Director-General for Family, Women’s and Children’s Health.

While unprecedented progress has been made in improving the lives of women and children around the world, maternal mortality rates have not declined to the levels set by the MDGs. Newborn mortality rates have fallen even more slowly and stillbirth rates have been stagnant. Despite efforts to date, each day 800 women and 7,700 newborns still die from complications during pregnancy, childbirth and other neonatal causes, and 7,300 women experience a stillbirth. Moreover, these deaths are not equally distributed within or between countries around the world.

As improved newborn survival and health are intrinsically linked with the health and survival of women before conception, during pregnancies and around the time of birth, a range of interventions across a continuum of quality care addressing reproductive, maternal, newborn, child and adolescent health is needed to address these preventable tragedies. In particular, improved access and quality of care around childbirth can generate a triple return on investment by saving maternal and newborn lives and preventing stillbirths and disability.

“Women and children need access to high-quality care and services across a continuum of care, including in fragile states where over half of the deaths occur,” said Kate Gilmore, Deputy Executive Director, UNFPA. “Seeing so many countries spring into action is testament that ending preventable maternal and child deaths and stillbirths within a generation is possible and a priority. The ENAP and EPMM plans are essential guidance to help countries reach their goals.”

Led and supported by many committed partners,* with particular leadership from WHO and UNICEF, the process to develop both EPMM and ENAP plans lasted more than two years and involved numerous multi-stakeholder consultations, official Member State input and web-based consultations drawing over 300 comments.

“Making newborns and mothers a priority on a global scale has catalyzed unprecedented action,” said Nina Schwalbe, UNICEF’s principal adviser on health. “We must keep this focus in the post-2015 era. The bold actions we take today to end preventable maternal and child mortality will lead to a better world tomorrow.”

*Partners: Bill & Melinda Gates Foundation; Family Care International; Human Reproduction Programme (HRP); International Confederation of Midwives; International Federation of Gynecology & Obstetrics (FIGO); London School of Hygiene & Tropical Medicine; Maternal and Child Survival Program; Maternal Health Task Force; Save the Children; The Partnership for Maternal, Newborn & Child Health; The White Ribbon Alliance; The World Bank; USAID; UNFPA; UNICEF; United Nations Foundation; World Health Organization

###

For a copy of the Every Newborn Action Plan Progress Report, please visit: EveryNewborn.org

For a copy of Strategies toward Ending Preventable Maternal Mortality, please visit: who.int/reproductivehealth/topics/maternal_perinatal/epmm/en/

About the Global Maternal Newborn Health Conference October 18 – 21, 2015, Mexico City
The Global Maternal Newborn Health Conference will provide a forum to identify, understand and respond to the most urgent health needs of mothers and newborns, focusing on quality care, integration and equity. The aim of the conference is to advance the technical knowledge; showcase innovative and effective solutions; consider successes and challenges of scaling up quality, integrated and equitable programmes; and accelerate momentum for maternal and newborn health within the post-2015 development framework. To find out more, visit: http://www.globalmnh2015.org/

About A Promise Renewed
Ending Preventable Maternal and Child Deaths: A Promise Renewed (APR) brings together governments, civil society, the private sector and individual citizens to stop women and children from dying of causes that are easily avoidable. In June 2012, the Governments of Ethiopia, India and the United States of America convened the Child Survival Call to Action in Washington, D.C. to rejuvenate the global child survival movement. Since the Child Survival Call to Action, over 178 governments and hundreds of civil society and faith based organizations have signed a pledge vowing to do everything possible to stop women and children from dying of causes that are easily avoidable. We now call this commitment Ending Preventable Maternal and Child Deaths: A Promise Renewed. Since the launch of A Promise Renewed, 30 countries have launched sharpened country strategies to end preventable maternal, newborn and child deaths. Read more at: www.apromiserenewed.org

About Every Woman Every Child (EWEC)
Launched by UN Secretary-General Ban Ki-moon during the United Nations Millennium Development Goals Summit in September 2010, Every Woman Every Child is an unprecedented global movement that mobilizes and intensifies international and national action by governments, multilaterals, the private sector and civil society to address the major health challenges facing women and children around the world. The movement puts into action the Global Strategy for Women’s and Children’s Health, which presents a roadmap on how to enhance financing, strengthen policy and improve service on the ground for the most vulnerable women and children.

About UNFPA
UNFPA: Delivering a world where every pregnancy is wanted, every childbirth is safe and every young person’s potential fulfilled. www.unfpa.org

About UNICEF
UNICEF promotes the rights and wellbeing of every child, in everything we do. Together with our partners, we work in 190 countries and territories to translate that commitment into practical action, focusing special effort on reaching the most vulnerable and excluded children, to the benefit of all children, everywhere. For more information about UNICEF and its work visit: www.unicef.org

Today the U.S. Food and Drug Administration allowed marketing of four diagnostic devices that can be used for high throughput gene sequencing, often referred to as “next generation sequencing” (NGS). These instruments, reagents, and test systems allow labs to sequence a patient’s DNA (deoxyribonucleic acid).

The new technology also gives physicians the ability to take a broader look at their patients’ genetic makeup and can help in diagnosing disease or identifying the cause of symptoms.

“NGS is changing the way we look at genomics,” said Alberto Gutierrez, Ph.D., director of the Office of In Vitro Diagnostics and Radiological Health in FDA’s Center for Devices and Radiological Health. “Before NGS, sequencing genes associated with a particular disease was a long and costly process. Today, we have the capability to read and interpret large segments of DNA very quickly in a single test and this information-rich technology is becoming more accessible for use by physicians in the care of their patients.”

Two of the newly cleared devices are used to detect DNA changes in the cystic fibrosis transmembrane conductance regulator (CFTR) gene, which can result in cystic fibrosis (CF), an inherited chronic disease that affects the lungs, pancreas, liver, intestines, and other organs of those who inherit a faulty CFTR gene from both parents.

More than 10 million Americans are CF carriers and approximately 30,000 children and adults in the U.S. are affected with CF. Most children with CF are diagnosed by age 2 and the average life span for people with CF who live to adulthood is approximately 37 years.

The cleared devices include:

The Illumina MiSeqDx Cystic Fibrosis 139-Variant Assay, which checks specific points in the patient’s CFTR gene sequence to detect known variants in the gene. Information about which DNA changes are associated with symptoms of cystic fibrosis is found in the Clinical and Functional TRanslation of CFTR database (CFTR2 disclaimer icon ).
The Illumina MiSeqDx Cystic Fibrosis Clinical Sequencing Assay, which sequences a large portion of the CFTR gene to detect any difference in the CFTR gene compared to a reference CFTR gene.

Data submitted by Illumina for their cystic fibrosis tests included comparisons of the sequence results to Human Genome Build 19, a reference representation of the human genome. In addition, Illumina evaluated the performance of its instrument and reagent systems against a publically available quality-weighted human reference genome that was created through collaboration between the FDA and the National Institutes of Standards and Technology (NIST).
FDA authorized sequencing devices provide labs with quality and performance information

The FDA also granted de novo petitions for the Illumina MiSeqDx instrument platform and the Illumina Universal Kit reagents, two devices that make up the first FDA-regulated test system that allows laboratories to develop and validate sequencing of any part of a patient’s genome. The Universal Kit reagents isolate and create copies of genes of interest obtained from patient blood samples, and the MiSeqDx platform analyzes the genes. The software compares the patient’s genomic sequence to a reference sequence and reports back any differences between the patient and the reference.

“The FDA’s review of the MiSeqDx and sequencer and Universal Kit reagents provides clinical laboratories with information about the expected performance of the device and the quality of the results,” said Dr. Gutierrez. “This information was not previously available for next generation sequencers, and, with this platform, labs can develop tests for clinical use with greater confidence because they use FDA authorized devices.”

The FDA reviewed the Illumina MiSeqDx instrument platform and the Illumina Universal Kit reagents through its de novo classification process, a regulatory pathway for some novel low-to-moderate risk medical devices that are not substantially equivalent to an already legally marketed device.

For the de novo petitions, the FDA based its decision on the demonstrated performance of the MiSeqDx instrument and Universal Kit reagent systems across numerous genomic segments spanning 19 human chromosomes.

Illumina MiSeqDx instrument platform, Universal Kit reagents, MiSeqDx Cystic Fibrosis 139-Variant Assay, and MiSeqDx Cystic Fibrosis Clinical Sequencing Assay are manufactured by Illumina, Inc. in San Diego, Calif.

This Press Release is Courtesy of USFDA

The U.S. Food and Drug Administration today announced a new comprehensive plan for tobacco and nicotine regulation that will serve as a multi-year roadmap to better protect kids and significantly reduce tobacco-related disease and death. The approach places nicotine, and the issue of addiction, at the center of the agency’s tobacco regulation efforts. The goal is to ensure that the FDA has the proper scientific and regulatory foundation to efficiently and effectively implement the Family Smoking Prevention and Tobacco Control Act. To make certain that the FDA is striking an appropriate balance between regulation and encouraging development of innovative tobacco products that may be less dangerous than cigarettes, the agency is also providing targeted relief on some timelines described in the May 2016 final rule that extended the FDA’s authority to additional tobacco products. The agency will also seek input on critical public health issues such as the role of flavors in tobacco products.

Tobacco use remains the leading cause of preventable disease and death in the United States, causing more than 480,000 deaths every single year. In addition to the devastating human toll caused mainly by cigarette smoking, tobacco also causes substantial financial costs to society, with direct health care and lost productivity costs totaling nearly $300 billion a year. A key piece of the FDA’s approach is demonstrating a greater awareness that nicotine – while highly addictive – is delivered through products that represent a continuum of risk and is most harmful when delivered through smoke particles in combustible cigarettes.

“The overwhelming amount of death and disease attributable to tobacco is caused by addiction to cigarettes – the only legal consumer product that, when used as intended, will kill half of all long-term users,” said FDA Commissioner Scott Gottlieb, M.D. “Unless we change course, 5.6 million young people alive today will die prematurely later in life from tobacco use. Envisioning a world where cigarettes would no longer create or sustain addiction, and where adults who still need or want nicotine could get it from alternative and less harmful sources, needs to be the cornerstone of our efforts – and we believe it’s vital that we pursue this common ground.”

The FDA plans to begin a public dialogue about lowering nicotine levels in combustible cigarettes to non-addictive levels through achievable product standards. The agency intends to issue an Advance Notice of Proposed Rulemaking (ANPRM) to seek input on the potential public health benefits and any possible adverse effects of lowering nicotine in cigarettes. Because almost 90 percent of adult smokers started smoking before the age of 18 and nearly 2,500 youth smoke their first cigarette every day in the U.S., lowering nicotine levels could decrease the likelihood that future generations become addicted to cigarettes and allow more currently addicted smokers to quit.

“Because nicotine lives at the core of both the problem and the solution to the question of addiction, addressing the addictive levels of nicotine in combustible cigarettes must be part of the FDA’s strategy for addressing the devastating, addiction crisis that is threatening American families,” said Commissioner Gottlieb. “Our approach to nicotine must be accompanied by a firm foundation of rules and standards for newly-regulated products. To be successful all of these steps must be done in concert and not in isolation.”

The FDA is committed to encouraging innovations that have the potential to make a notable public health difference and inform policies and efforts that will best protect kids and help smokers quit cigarettes. To make this effort successful, the agency intends to extend timelines to submit tobacco product review applications for newly regulated tobacco products that were on the market as of Aug. 8, 2016. This action will afford the agency time to explore clear and meaningful measures to make tobacco products less toxic, appealing and addictive. For example, the FDA intends to develop product standards to protect against known public health risks such as electronic nicotine delivery systems (ENDS) battery issues and concerns about children’s exposure to liquid nicotine. It also will provide manufacturers additional time to develop higher quality, more complete applications informed by additional guidance from the agency.

The agency plans to issue this guidance describing a new enforcement policy shortly. Under expected revised timelines, applications for newly-regulated combustible products, such as cigars, pipe tobacco and hookah tobacco, would be submitted by Aug. 8, 2021, and applications for non-combustible products such as ENDS or e-cigarettes would be submitted by Aug. 8, 2022. Additionally, the FDA expects that manufacturers would continue to market products while the agency reviews product applications.

Importantly, the anticipated new enforcement policy will not affect any current requirements for cigarettes and smokeless tobacco, only the newly-regulated tobacco products such as cigars and e-cigarettes. This approach also will not apply to provisions of the final rule for which compliance deadlines already have passed, such as mandatory age and photo-ID checks to prevent illegal sales to minors. It also will not affect future deadlines for other provisions of the rule, including, but not limited to, required warning statements, ingredient listing, health document submissions, harmful and potentially harmful constituent reports, and the removal of modified risk claims, i.e., “light,” “low,” or “mild,” or similar descriptors.

In order to further explore how best to protect public health in the evolving tobacco marketplace, the agency also will seek input from the public on a variety of significant topics, including approaches to regulating kid-appealing flavors in e-cigarettes and cigars. In particular, the FDA intends to issue ANPRMs to: 1) seek public comment on the role that flavors (including menthol) in tobacco products play in attracting youth and may play in helping some smokers switch to potentially less harmful forms of nicotine delivery; and 2) solicit additional comments and scientific data related to the patterns of use and resulting public health impacts from premium cigars, which were included in the FDA’s 2016 rule. Additionally, the agency plans to examine actions to increase access and use of FDA-approved medicinal nicotine products, and work with sponsors to consider what steps can be taken under the safety and efficacy standard for products intended to help smokers quit.

“This comprehensive plan and sweeping approach to tobacco and nicotine allows the FDA to apply the powerful tools given by Congress to achieve the most significant public health impact,” said Mitch Zeller, J.D., director of the FDA’s Center for Tobacco Products. “Public input on these complex issues will help ensure the agency has the proper science-based policies in place to meaningfully reduce the harms caused by tobacco use.”

To complement these larger policy considerations, the FDA plans to issue foundational rules to make the product review process more efficient, predictable, and transparent for manufacturers, while upholding the agency’s public health mission. Among other things, the FDA intends to issue regulations outlining what information the agency expects to be included in Premarket Tobacco Applications (PMTAs), Modified Risk Tobacco Product (MRTP) applications and reports to demonstrate Substantial Equivalence (SE). The FDA also plans to finalize guidance on how it intends to review PMTAs for ENDS. The agency also will continue efforts to assist industry in complying with federal tobacco regulations through online information, meetings, webinars and guidance documents.

The FDA, an agency within the U.S. Department of Health and Human Services, promotes and protects the public health by, among other things, assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

In a continuing effort to educate prescribers and patients about the potential risks related to opioid use, the U.S. Food and Drug Administration today announced required class-wide safety labeling changes for immediate-release (IR) opioid pain medications. Among the changes, the FDA is requiring a new boxed warning about the serious risks of misuse, abuse, addiction, overdose and death. Today’s actions are among a number of steps the agency recently outlined in a plan to reassess its approach to opioid medications. The plan is focused on policies aimed at reversing the epidemic, while still providing patients in pain access to effective relief.

The FDA is also requiring several additional safety labeling changes across all prescription opioid products to include additional information on the risk of these medications. This is part of the agency’s overall effort to help inform prescribers about the importance of balancing the serious risks of opioids with their role in managing pain.

“Opioid addiction and overdose have reached epidemic levels over the past decade, and the FDA remains steadfast in our commitment to do our part to help reverse the devastating impact of the misuse and abuse of prescription opioids,” said Robert Califf, M.D., FDA commissioner. “Today’s actions are one of the largest undertakings for informing prescribers of risks across opioid products, and one of many steps the FDA intends to take this year as part of our comprehensive action plan to reverse this epidemic.”

Opioid analgesics are powerful pain-reducing medications that include prescription oxycodone, hydrocodone and morphine, among others. Prescription opioids are divided into two main categories – IR products, usually intended for use every four to six hours; and extended-release/long-acting (ER/LA) products, which are primarily intended to be taken once or twice a day, depending on the individual product and patient. Certain opioids, such as methadone and buprenorphine, are also used as a form of treatment for opioid addiction, and in combination with behavioral therapy and counseling, are known as medication-assisted treatment, or MAT.

The updated indication clarifies that because of these risks, IR opioids should be reserved for pain severe enough to require opioid treatment and for which alternative treatment options (e.g., non-opioid analgesics or opioid combination products, as appropriate) are inadequate or not tolerated. The dosing information also provides clearer instructions regarding patient monitoring and drug administration, including initial dosage, dosage changes during therapy and a warning not to abruptly stop treatment in a physically dependent patient.

As part of the boxed warning on IR opioid analgesics, the FDA now requires a precaution that chronic maternal use of opioids during pregnancy can result in neonatal opioid withdrawal syndrome (NOWS), which may be life-threatening if not recognized and treated using protocols developed by neonatology experts. NOWS may occur in a newborn exposed to opioid drugs for a prolonged period while in utero.

In 2013, the FDA required class-wide labeling changes for ER/LA opioid analgesics that included modifications to the products’ indications, limitations of use, and warnings, including boxed warnings to more effectively communicate to prescribers the serious risks associated with these drugs. Today, the FDA is requiring similar changes to the labeling of IR opioid analgesics.

“We know that there is persistent abuse, addiction, overdose mortality and risk of NOWS associated with IR opioid products,” said Douglas Throckmorton, M.D., deputy center director of regulatory programs, FDA’s Center for Drug Evaluation and Research. “Today, we have taken an important next step in clarifying and making more prominent the known risks of IR opioid medications.”

Additionally, the FDA is requiring updated labeling for all opioids (both ER/LA and IR products) to include safety information about potentially harmful drug interactions with other medicines that can result in a serious central nervous system condition called serotonin syndrome. Updated labeling will also include information about opioid effects on the endocrine system, including a rare but serious disorder of the adrenal glands (called adrenal insufficiency) and decreased sex hormone levels (androgen deficiency). These labeling changes will also make it clear that these negative outcomes can occur whether a patient is taking an opioid to treat pain or if the product is being used for MAT. Today, the FDA issued a Drug Safety Communication outlining these risks.

“The broad set of actions announced today is reflective of the FDA’s efforts to improve informed prescribing of opioids across the board,” said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research. “We have been and will continue to evaluate all new data to ensure that labels of opioid drugs contain appropriate prescribing information about the benefits and risks of prescription opioids.”

The FDA is also aware of, and carefully reviewing, available scientific information about potentially serious outcomes related to interactions between benzodiazepines and opioids. Once a review of all available scientific information is completed, the FDA will take necessary actions to ensure prescribers and the public are informed of the risks involved with the use of these medications.

These actions are the latest examples of the agency’s commitment to combat this public health crisis and its profound impact on individuals, families and communities across our country. Health and Human Services Secretary Sylvia M. Burwell has made addressing opioid misuse, addiction and overdose a priority. Other work on this important issue is underway within HHS. The evidence-based HHS-wide opioid initiative focuses on three priority areas: informing opioid prescribing practices, increasing the use of naloxone (a rescue medication that can prevent death from overdose) and expanding access to and the use of MAT to treat opioid use disorder.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

The U.S. Food and Drug Administration today approved Farxiga (dapaglifozin) tablets to improve glycemic control, along with diet and exercise, in adults with type 2 diabetes.

Type 2 diabetes affects about 24 million people and accounts for more than 90 percent of diabetes cases diagnosed in the United States. Over time, high blood sugar levels can increase the risk for serious complications, including heart disease, blindness, and nerve and kidney damage.

“Controlling blood sugar levels is very important in the overall treatment and care of diabetes, and Farxiga provides an additional treatment option for millions of Americans with type 2 diabetes,” said Curtis Rosebraugh, M.D., M.P.H., director of the Office of Drug Evaluation II in the FDA’s Center for Drug Evaluation and Research.

Farxiga is a sodium-glucose co-transporter 2 (SGLT2) inhibitor that blocks the reabsorption of glucose by the kidney, increases glucose excretion, and lowers blood glucose levels. The drug’s safety and effectiveness were evaluated in 16 clinical trials involving more than 9,400 patients with type 2 diabetes. The trials showed improvement in HbA1c (hemoglogin A1c or glycosylated hemoglobin, a measure of blood sugar control).

Farxiga has been studied as a stand-alone therapy and in combination with other type 2 diabetes therapies including metformin, pioglitazone, glimepiride, sitagliptin, and insulin. Farxiga should not be used to treat people with type 1 diabetes; those who have increased ketones in their blood or urine (diabetic ketoacidosis); or those with moderate or severe renal impairment, end stage renal disease, or patients on dialysis.

An increased number of bladder cancers were diagnosed among Farxiga users in clinical trials so Farxiga is not recommended for patients with active bladder cancer. Patients with a history of bladder cancer should talk to their physician before using Farxiga. Farxiga can cause dehydration, leading to a drop in blood pressure (hypotension) that can result in dizziness and/or fainting and a decline in renal function. The elderly, patients with impaired renal function, and patients on diuretics to treat other conditions appeared to be more susceptible to this risk.

The FDA is requiring six post-marketing studies for Farxiga:

a cardiovascular outcomes trial (CVOT) to evaluate the cardiovascular risk of Farxiga in patients with high baseline risk of cardiovascular disease;
a double-blind, randomized, controlled assessment of bladder cancer risk in patients enrolled in the CVOT;
an animal study evaluating the role of Farxiga-induced urinary flow/rate and composition changes on bladder tumor promotion in rodents;
two clinical trials to assess the pharmacokinetics, efficacy, and safety in pediatric patients; and
an enhanced pharmacovigilance program to monitor reports of liver abnormalities and pregnancy outcomes.
In clinical trials the most common side effects observed in patients treated with Farxiga were genital mycotic (fungal) infections and urinary tract infections.

Farxiga is marketed by Bristol-Meyers Squibb Company, Princeton, N.J. and AstraZeneca Pharmaceuticals L.P., Wilmington, Del.

This Press Release is courtesy of www.fda.gov

The U.S. Food and Drug Administration today approved Sovaldi (sofosbuvir) to treat chronic hepatitis C virus (HCV) infection. Sovaldi is the first drug that has demonstrated safety and efficacy to treat certain types of HCV infection without the need for co-administration of interferon.

“Today’s approval represents a significant shift in the treatment paradigm for some patients with chronic hepatitis C,” said Edward Cox, M.D., director of the Office of Antimicrobial Products in the FDA’s Center for Drug Evaluation and Research.

Sovaldi is the second drug approved by the FDA in the past two weeks to treat chronic HCV infection. On November 22, the FDA approved Olysio (simeprevir).

Hepatitis C is a viral disease that causes inflammation of the liver that can lead to diminished liver function or liver failure. Most people infected with HCV have no symptoms of the disease until liver damage becomes apparent, which may take several years. Some people with chronic HCV infection develop scarring and poor liver function (cirrhosis) over many years, which can lead to complications such as bleeding, jaundice (yellowish eyes or skin), fluid accumulation in the abdomen, infections or liver cancer. According to the Centers for Disease Control and Prevention, about 3.2 million Americans are infected with HCV.

Sovaldi is a nucleotide analog inhibitor that blocks a specific protein needed by the hepatitis C virus to replicate. Sovaldi is to be used as a component of a combination antiviral treatment regimen for chronic HCV infection. There are several different types of HCV infection. Depending on the type of HCV infection a patient has, the treatment regimen could include Sovaldi and ribavirin or Sovaldi, ribavirin and peginterferon-alfa. Ribavirin and peginterferon-alfa are two drugs also used to treat HCV infection.

Sovaldi’s effectiveness was evaluated in six clinical trials consisting of 1,947 participants who had not previously received treatment for their disease (treatment-naive) or had not responded to previous treatment (treatment-experienced), including participants co-infected with HCV and HIV. The trials were designed to measure whether the hepatitis C virus was no longer detected in the blood at least 12 weeks after finishing treatment (sustained virologic response), suggesting a participant’s HCV infection has been cured.

Results from all clinical trials showed a treatment regimen containing Sovaldi was effective in treating multiple types of the hepatitis C virus. Additionally, Sovaldi demonstrated efficacy in participants who could not tolerate or take an interferon-based treatment regimen and in participants with liver cancer awaiting liver transplantation, addressing unmet medical needs in these populations.

The most common side effects reported in clinical study participants treated with Sovaldi and ribavirin were fatigue and headache. In participants treated with Sovaldi, ribavirin and peginterferon-alfa, the most common side effects reported were fatigue, headache, nausea, insomnia and anemia.

Sovaldi is the third drug with breakthrough therapy designation to receive FDA approval. The FDA can designate a drug as a breakthrough therapy at the request of the sponsor if preliminary clinical evidence indicates the drug may demonstrate a substantial improvement over available therapies for patients with serious or life-threatening diseases. Sovaldi was reviewed under the FDA’s priority review program, which provides for an expedited review of drugs that treat serious conditions and, if approved, would provide significant improvement in safety or effectiveness.

Sovaldi is marketed by Gilead, based in Foster City, Calif. Olysio is marketed by Raritan, N.J.-based Janssen Pharmaceuticals.

This Press Release is Courtesy of www.FDA.gov

The U.S. Food and Drug Administration today notified Ranbaxy Laboratories, Ltd., that it is prohibited from manufacturing and distributing active pharmaceutical ingredients (APIs) from its facility in Toansa, India, for FDA-regulated drug products. The Toansa facility is now subject to certain terms of a consent decree of permanent injunction entered against Ranbaxy in January 2012.

The decree contains, among other things, provisions to ensure compliance with current good manufacturing practice (CGMP) requirements at Ranbaxy facilities in Paonta Sahib and Dewas, India, as well as provisions to address data integrity issues at those facilities. In September 2013, the FDA added Ranbaxy’s Mohali facility to the CGMP provisions of the decree.

Under the decree, the FDA has issued an order prohibiting Ranbaxy from:

• distributing in the United States drugs manufactured using API from Toansa, including drugs made by Ranbaxy’s Ohm Laboratories facility in New Jersey;
• manufacturing API at its Toansa facility for FDA-regulated drug products;
• exporting API from Toansa to the United States for any purpose; and
• providing API from Toansa to other companies, including other Ranbaxy facilities, making products for American consumers.

“We are taking swift action to prevent substandard quality products from reaching U.S. consumers,” said Carol Bennett, acting director of the Office of Compliance in the FDA’s Center for Drug Evaluation and Research. “The FDA is committed to ensuring that the drugs American consumers receive – no matter where they are produced – meet quality standards and are safe and effective.”

The FDA exercised its authority under a provision in the consent decree which permits the agency to extend the decree’s terms to any Ranbaxy-owned or operated facility if an FDA inspection finds the facility in violation of the Federal Food, Drug, and Cosmetic Act or FDA regulations, including CGMP requirements. CGMP requirements serve as the primary regulatory safeguard over drug manufacturing and must be followed by companies to ensure manufacturing quality. The FDA also acted under a separate provision in the decree which permits the agency to order additional corrective actions that FDA determines are necessary to achieve compliance with the law or the decree.

The FDA’s inspection of the Toansa facility, which concluded on Jan. 11, 2014, identified significant CGMP violations. These included Toansa staff retesting raw materials, intermediate drug products, and finished API after those items failed analytical testing and specifications, in order to produce acceptable findings, and subsequently not reporting or investigating these failures.

The agency is evaluating potential drug shortage issues that may result from this action. If the FDA determines that a medically necessary drug is in shortage or at risk of shortage, the FDA may modify this order to preserve patient access to drugs manufactured under controls that are sufficient to assure quality, safety and effectiveness.

As a result of this action, Ranbaxy is now prohibited from manufacturing API for FDA-regulated drugs at the Toansa facility and from introducing API from that facility into interstate commerce, including into the United States, until the firm’s methods and controls used to manufacture drugs at the Toansa facility are established, operated and administered in compliance with CGMP.

Ranbaxy is required to hire a third-party expert to thoroughly inspect the Toansa facility and certify to the FDA that the facility and its methods and controls are adequate to ensure continuous compliance with CGMP. Ranbaxy will not be permitted to resume manufacturing and distributing API for FDA-regulated drugs from the Toansa facility until the agency is satisfied that Ranbaxy has addressed its manufacturing quality issues at that facility.

The FDA recommends that patients not disrupt their drug therapy because this could jeopardize their health. Patients who are concerned about their medications should talk with their health care professional before discontinuing treatment.

This Press Release is courtesy www.fda.gov

Based on extensive outreach and public comment, the U.S. Food and Drug Administration today proposed revisions to four proposed rules designed to help prevent food-borne illness. When finalized, the proposed rules will implement portions of the FDA Food Safety Modernization Act (FSMA), which aims to strengthen food safety by shifting the focus to preventing food safety problems rather than responding to problems after the fact.

Since FSMA was signed into law in January 2011, the FDA has proposed seven rules to implement FSMA. The four updated proposed rules include: produce-safety; preventive controls for human food; preventive controls for animal food; and the foreign supplier verification program.

“Ensuring a safe and high-quality food supply is one of the FDA’s highest priorities, and we have worked very hard to gather and respond to comments from farmers and other stakeholders regarding the major proposed FSMA regulations,” said FDA Commissioner Margaret A. Hamburg, M.D. “The FDA believes these updated proposed rules will lead to a modern, science-based food safety system that will better protect American consumers from potentially hazardous food. We look forward to public comment on these proposals.”

The FDA is making changes to key provisions of the four proposed rules based on feedback received from the public during meetings and thousands of comments submitted to the agency on the proposed rules.

“Based on valuable input from farmers, consumers, the food-industry and academic experts, the FDA is proposing to update these four proposed rules to ensure a more flexible and targeted means to ensure food safety,” said Michael R. Taylor, the FDA’s deputy commissioner for foods and veterinary medicine.

In response to public comments, the FDA is proposing to revise the water quality testing provisions in the proposed produce safety rule to account for natural variations in water sources and to adjust its approach to manure and compost used in crop production pending further research on this issue.

The FDA also is proposing, based on feedback received to date, a new definition of which farms would be subject to the produce-safety rule. The proposed rule would not apply to farms with $25,000 or less in produce sales, rather than setting the threshold based on sales of all foods produced on the farm. The updated proposed rules also propose to simplify which entities are covered by the produce safety rule and which would be covered by the preventive controls rules.

The revisions also address the issue of the use of spent grains, which are by-products of alcoholic beverage brewing and distilling that are commonly used as animal food. Concerns were raised that the proposed rules would require brewers and distillers to comply with the full human food and animal food rules if they made their wet spent grains available for animal feed. The updated proposed rule would clarify that human food processors that create by-products used as animal food and are already complying with FDA human food safety requirements — such as producers of wet spent grains — would not need to comply with the full animal food rule if they are already complying with the human-food rule.

Revisions to the foreign-supplier verification proposed rule give importers more flexibility to determine appropriate supplier verification measures based on risk and previous experience with their suppliers.

The FDA will accept comments on the proposed revisions of the four proposed rules for 75 days while continuing to review comments already received on the sections of the proposed rules that are staying the same. The agency will consider both sets of comments before issuing final rules in 2015.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

The U.S. Food and Drug Administration is advising consumers to immediately stop using a product called Mass Destruction, marketed as a dietary supplement for muscle growth. The product is labeled to contain at least one synthetic anabolic steroid and has been linked to at least one reported serious illness.

The FDA was alerted by the North Carolina Department of Health and Human Services of a serious injury associated with use of Mass Destruction. The report described a previously healthy 28-year-old male with liver failure requiring transplant after several weeks of product use. Liver injury is generally known to be a possible outcome of using products that contain anabolic steroids and steroid-like substances. The product’s ingredients are undergoing further analysis by the FDA.

Mass Destruction is manufactured for Blunt Force Nutrition in Sims, N.C. and sold in retail stores, fitness gyms, and on the Internet. An investigation is underway to identify the product’s manufacturer. Consumers who suspect they are experiencing problems associated with Mass Destruction or other body building products should consult a health care professional, especially if they have experienced unexplained fatigue, abdominal or back pain, discolored urine, or any other unexplained changes in their health.

“Products marketed as supplements that contain anabolic steroids pose a real danger to consumers,” said Howard Sklamberg, director of the Office of Compliance in the FDA’s Center for Drug Evaluation and Research. “The FDA is committed to ensuring that products marketed as dietary supplements and vitamins do not pose harm to consumers.”

In general, anabolic steroids may cause other serious long-term consequences in women, men and children. These include adverse effects on blood lipid levels; increased risk of heart attack and stroke; masculinization of women; shrinkage of the testicles; breast enlargement; infertility in males; and short stature in children.

This Press Release is courtesy of USFDA www.fda.gov

In response to a request by Massachusetts State Representative Bradley H. Jones, the Federal Trade Commission and the Department of Justice’s Antitrust Division have submitted a statement encouraging the Massachusetts legislature to consider expanding the services that optometrists can provide to glaucoma patients. Specifically, Representative Jones asked the agencies for views on the possible competitive impact of Massachusetts House Bill 1973 (HB 1973), which would expand the scope of practice for optometrists in Massachusetts by permitting them to treat glaucoma and other optical diseases.

Glaucoma affects 2.7 million Americans, and early diagnosis and managed treatment offer protection against the risk of vision loss or blindness. With respect to glaucoma care, HB 1973 would allow optometrists to treat glaucoma patients using medications, subject to certain training and referral requirements, as optometrists do in other states.

The statement, which is limited to the bill’s effect on glaucoma care, describes the potential benefits to patients of enhanced competition among glaucoma care providers, including greater access to timely and cost-competitive care, noting that unnecessarily broad scope of practice restrictions “can impose significant competitive costs on health care consumers and other payors.” It recommends that the legislature restrict optometrists’ ability to treat glaucoma only to the extent necessary to ensure patient health and safety.

SAN FRANCISCO- Fitbit, Inc. (NYSE: FIT) today announced that it has entered into a definitive agreement to be acquired by Google LLC for $7.35 per share in cash, valuing the company at a fully diluted equity value of approximately $2.1 billion.

“More than 12 years ago, we set an audacious company vision – to make everyone in the world healthier. Today, I’m incredibly proud of what we’ve achieved towards reaching that goal. We have built a trusted brand that supports more than 28 million active users around the globe who rely on our products to live a healthier, more active life,” said James Park, co-founder and CEO of Fitbit. “Google is an ideal partner to advance our mission. With Google’s resources and global platform, Fitbit will be able to accelerate innovation in the wearables category, scale faster, and make health even more accessible to everyone. I could not be more excited for what lies ahead.”

“Fitbit has been a true pioneer in the industry and has created terrific products, experiences and a vibrant community of users,” said Rick Osterloh, Senior Vice President, Devices & Services at Google. “We’re looking forward to working with the incredible talent at Fitbit, and bringing together the best hardware, software and AI, to build wearables to help even more people around the world.”

Fitbit pioneered the wearables category by delivering innovative, affordable and engaging devices and services. Being “on Fitbit” is not just about the device – it is an immersive experience from the wrist to the app, designed to help users understand and change their behavior to improve their health. Because of this unique approach, Fitbit has sold more than 100 million devices and supports an engaged global community of millions of active users, utilizing data to deliver unique personalized guidance and coaching to its users. Fitbit will continue to remain platform-agnostic across both Android and iOS.

Consumer trust is paramount to Fitbit. Strong privacy and security guidelines have been part of Fitbit’s DNA since day one, and this will not change. Fitbit will continue to put users in control of their data and will remain transparent about the data it collects and why. The company never sells personal information, and Fitbit health and wellness data will not be used for Google ads.

The transaction is expected to close in 2020, subject to customary closing conditions, including approval by Fitbit’s stockholders and regulatory approvals.

Qatalyst Partners LLP acted as financial advisor to Fitbit, and Fenwick & West LLP acted as legal advisor.

About Fitbit, Inc. (NYSE: FIT)

Fitbit helps people lead healthier, more active lives by empowering them with data, inspiration and guidance to reach their goals. Fitbit designs products and experiences that track and provide motivation for everyday health and fitness. Fitbit’s diverse line of innovative and popular products include Fitbit Charge 3™, Fitbit Inspire HR™, Fitbit Inspire™ and Fitbit Ace 2™ activity trackers, as well as the Fitbit Ionic™ and Fitbit Versa™ family of smartwatches, Fitbit Flyer™ wireless headphones, and Fitbit Aria family of smart scales. Fitbit products are carried in approximately 39,000 retail stores and in 100+ countries around the globe. Powered by one of the world’s largest databases of activity, exercise and sleep data and Fitbit’s leading health and fitness social network, the Fitbit platform delivers personalized experiences, insights and guidance through leading software and interactive tools, including the Fitbit and Fitbit Coach apps, and Fitbit OS for smartwatches. Fitbit’s paid subscription service, Fitbit Premium, uses your unique data to deliver actionable guidance and coaching in the Fitbit app to help you reach your health and fitness goals. Fitbit Health Solutions develops health and wellness solutions designed to help increase engagement, improve health outcomes, and drive a positive return for employers, health plans and health systems.

Grants ranging from $40,000 to $50,000 will support organizations that address health needs for Kansans who live in rural and frontier areas
Programs must encourage a “whole person” approach to care, leverage telehealth or incorporate community health workers
UnitedHealthcare accepting RFPs by nonprofits, Federally Qualified Health Centers and other organizations at communitygrants@uhc.com
TOPEKA, Kan. (Feb. 06, 2017) —
UnitedHealthcare is now accepting proposals from community nonprofits and government agencies aimed at improving health resources and programs for Kansas residents living in rural and frontier areas.

The RFP was developed following a community brainstorming session that brought together health care providers and other stakeholders from across the state to develop strategies to address the issue. Initial grants will range from $40,000 to $50,000 each. Funding will be provided to programs and one-time projects for up to 12 months.

Programs and projects must meet at least one of the following priorities:

Integrate behavioral and physical health care systems to encourage a “whole person” approach to care.
Leverage telehealth: behavioral health specialists, primary care/specialists, health educators and peer support.
Further develop workforce/incorporate community health workers.
Kansans who live in rural and frontier areas often have to travel long distances to see a health care provider, and limited options can make accessing preventive, specialty and emergency care challenging. In addition:

According to the Kansas Department of Health and Environment, approximately 30 percent of Kansans live in rural or frontier areas, with more than 80 counties established as areas with shortages of primary care health professionals1.
According to 2016 KIDS COUNT data, youth in rural and frontier Kansas have a higher percentage of teen violent deaths, tobacco use and binge drinking compared to kids in urban and semi-urban Kansas.
In the past year, the number of Kansas children in poverty increased 3.8 percent, according UnitedHealth Foundation’s America’s Health RankingsTM report.
“We recognize the health challenges facing many people living in rural and frontier areas, and welcome the opportunity to partner with the community to improve access to the quality health care that Kansans need and deserve,” said Kevin Sparks, CEO, UnitedHealthcare Community Plan of Kansas.

Qualifying organizations, including Kansas-based nonprofits, Federally Quality Health Centers (FQHCs) and public/government agencies can receive the full RFP by contacting communitygrants@uhc.com. Applicants that do not meet this qualification may apply in partnership with one of the organizations listed above as the lead organization. Proposals are due Feb. 17, 2017. Awardees will be notified by April 28, 2017.

About UnitedHealthcare
UnitedHealthcare is dedicated to helping people nationwide live healthier lives by simplifying the health care experience, meeting consumer health and wellness needs, and sustaining trusted relationships with care providers. The company offers the full spectrum of health benefit programs for individuals, employers, military service members, retirees and their families, and Medicare and Medicaid beneficiaries, and contracts directly with more than 1 million physicians and care professionals, and 6,000 hospitals and other care facilities nationwide. UnitedHealthcare is one of the businesses of UnitedHealth Group (NYSE: UNH), a diversified Fortune 50 health and well-being company. For more information, visit UnitedHealthcare at www.uhc.com or follow @myUHC on Twitter.

GENEVA: Commitments made at today’s Virtual G7 leaders meeting hosted by UK Prime Minister Boris Johnson, and at the Munich Security Conference later in the day, signaled significant progress in the global response to the COVID-19 pandemic with an important underscoring of the need for global equity in access to test, treatments, and vaccines.

Leaders recognised that no country can be safe until every country is safe and collectively committed over US $4.3 billion to the ACT Accelerator partnership to develop and distribute effective tests, treatments, and vaccines around the world. https://www.g7uk.org/joint-statement-of-g7-leaders-19-february-2021/

Contributions were made up as follows:

·        The US committed initial $2 billion to Gavi, the Vaccine Alliance for the COVAX Advance Market Commitment and a further $2 billion through 2021 and 2022, of which the first $500 million will be made available when existing donor pledges are fulfilled and initial doses are delivered to AMC countries.

·        Germany committed US$ 1.8 billion[i] with contributions to all pillars and partners of the ACT Accelerator across tests, treatments, vaccines, and health systems strengthening.

·        The European Commission committed US$ 363 million[ii] for the COVAX Advance Market Commitment.

·        Japan committed US$ 79 million for the COVAX Advance Market Commitment and UNITAID.

·        Canada committed US$ 59 million to the ACT Accelerator.[iii]

In addition, the European Investment Bank is providing a further US$ 242 million[iv] in loan guarantees which will help the ACT Accelerator partnership to frontload future payments to speed up the response.

The UK’s commitment to join Canada, France, Norway and the European Union in sharing its additional vaccine doses with developing countries is a vital step to increase volume of vaccines available worldwide and support rapid reduction of virus transmission amongst some of the world’s our most vulnerable and exposed populations.

The ACT Accelerator initial needs for 2020-2021 were US $38.1 billion. Prior to today, an unprecedented mobilization of sovereign donors, private sectors, philanthropic and multilateral contributors had already committed US $ 6 billion. Considering those pledges, and costs adjustments, today’s new contributions bring the total committed to the ACT Accelerator partnership to US$ 10.3 billion and reduce the funding gap to US$ 22.9 billion.

The next few weeks will be critical for the global COVID-19 response. Further commitments are needed to fully fund the work of the ACT Accelerator and enable the delivery of more than 2 billion doses of vaccine; medical oxygen and millions of treatment doses including dexamethasone and new products, as and when they become available; and over 900 million diagnostic tests including high-quality, lower-cost molecular tests, antigen detection RDTs (Ag-RDTs) and self-tests. This work will also support the urgent need for rapid R&D, product evaluation, and regulatory pathways for new and modified tests, treatments and vaccines to meet the needs of global response programmes and the threat of new and emerging variants.

Global health leaders responded to today’s announcements:

Dr Tedros Adhanom Ghebreyesus, Director-General of WHO, said: “I thank the US, Germany, the European Commission, the European Investment Bank, Japan, and Canada for their significant funding commitments. Today’s news shows us solidarity prevails; we can turn a corner on this pandemic by funding the only global solution to end it. History will judge us collectively and I welcome the words of support from today’s G7 Leaders and the Munich Security Council for again highlighting to the world that we have to solve this together.”

Dr. Seth Berkley, CEO of Gavi, the Vaccine Alliance, said: “This support for the Gavi COVAX AMC shows great commitment to equitable, global access to COVID-19 vaccines and is a major boost to our efforts to end the acute phase of the pandemic. We thank G7 countries, and particularly Germany and the United States, as well as the EU, for this strong leadership in the fields of global health and global health security.” 

Dr Catharina Boehme, CEO of FIND, said: “Today’s new commitment is gladly welcomed. Over a year into the pandemic, inequality in testing remains across the globe, meaning that many countries are still flying blind in their pandemic response even as new variants emerge. For every test conducted in Africa, Europe is conducting 33. The pandemic will not be defeated until every country can access the tests, treatments and vaccines it needs to keep everyone safe.”

Peter Sands, Executive Director of Global Fund, said: “The Global Fund welcomes these significant contributions to the ACT-Accelerator.  As the virus evolves, it is important to ensure equitable access to tests, treatments, vaccines and PPE to defeat COVID-19 and save lives. Galvanizing a bolder, faster  and more unified response should be a top priority for everyone. The longer COVID-19 is left unchecked in some parts of the world, the more the risk of new variants and the greater the knock-on impact on economies and other deadly diseases. We must act together now.”

Dr Philippe Duneton, Executive Director of Unitaid, said: “Unitaid welcomes such strong commitment to the vital work of the ACT-Accelerator. Treatments for COVID-19 are needed to save lives and provide a second line of defense against a mutating virus. This investment will aid our work to ensure promising treatments reach people everywhere.”

Dr Richard Hatchett, CEO of CEPI, said: “We are entering a new and more complex phase of the pandemic. The emergence of novel variants that threaten to impact the safe and effective vaccines we have developed means that now, more than ever, we are in a race against this virus. It is paramount that we take this opportunity to not only push forward with our plan to end the acute phase of this devastating crisis, but also continue to focus on ensuring we invest in R&D, work for globally fair distribution, and build on our scientific achievements to meet the continued challenge of this pandemic. We welcome the G7’s leadership and focus on advancing COVID-19 vaccine development and deployment, in addition to their commitments to increase manufacturing capacity and share genomic sequencing information so that we can accelerate our work and continue to provide the tools the world so urgently needs. There is a moment of opportunity that we must now seize to collaborate in our efforts to stop the devastation of this pandemic.”

PITTSBURGH, PA — GE Healthcare announced today a strategic partnership with Real Time Medical, an award-winning developer of workflow management software solutions. The agreement will allow GE Healthcare to offer a streamlined workflow that seamlessly connects pathologists and other clinicians, facilitating collaboration to help enhance accuracy and speed of diagnosis.
Empowering pathologists with information technology to remove manual processes and delays, GE Healthcare now offers OmnyxTM IDP, a scanner and software solution to allow pathologists to digitally view and share slide images with colleagues across locations. The addition of Real Time Medical’s DiaShareTM workflow management platform will further speed up the process, connecting pathologists in real time by creating a workflow, which automatically alerts colleagues to new cases to review, tracks progress and allows pathologists to report results.

By offering OmnyxTM IDP and DiaShareTM as a combined solution, GE Healthcare is now advancing its digital pathology capabilities by connecting networks and delivering smooth sub-specialty workflows in anatomic pathology. Pathologists can now share image data and collaborate with peers in near real time to improve decision making and facilitate learning.

Omnyx CEO Mamar Gelaye said: “There has been huge investment in information technology in most areas of the hospital to improve clinical outcomes and productivity, but little has been done to empower the pathologist. For a long time, pathologists have been disconnected — from each other and from other clinicians and patient data.

“This solution empowers decision making for pathologists, enabling them to collaborate more easily and quickly with their colleagues. Today, Omnyx helps pathologists be better connected—they still have to alert colleagues manually to cases to review in the system. Now, by combining our Omnyx solution with Real Time Medical’s DiaShareTM, platform we are able to go one step further. Our combined solutions address important needs to further streamline the pathology workflow which will improve access to subspecialty expertise within a single, intuitive workflow.”

Ian Maynard, CEO and Co-Founder of Real Time Medical, said: “Our DiaShareTM workflow management platform is a multi-disciplinary digital imaging solution that was designed to drive operational efficiencies, enhance productivity, and improve quality of care. We are excited by the opportunity to help transform ways of working for pathologists and to be working with GE Healthcare and Omnyx as strategic partners.”

OmnyxTM IDP solutions are offered for primary diagnostic use in Europe and Canada, and for limited clinical use as well as research use in the United States.
Omnyx is a trademark of Omnyx, LLC.

DiaShareTM is a trademark of Real Time Medical.

About GE Healthcare
GE Healthcare provides transformational medical technologies and services to meet the demand for increased access, enhanced quality and more affordable healthcare around the world. GE (NYSE: GE) works on things that matter – great people and technologies taking on tough challenges. From medical imaging, software & IT, patient monitoring and diagnostics to drug discovery, biopharmaceutical manufacturing technologies and performance improvement solutions, GE Healthcare helps medical professionals deliver great healthcare to their patients.
About Omnyx
Omnyx, LLC is a joint venture of GE Healthcare and UPMC (University of Pittsburgh Medical Center) with locations in Pittsburgh, PA and Piscataway, NJ. The company has developed the OmnyxTM IDP solution allowing pathology departments worldwide to move to an all-digital workflow. Their products include image acquisition devices, workflow software, and transformation consulting. Close collaboration with pathologists at UPMC and other institutions along with their relationship with GE Healthcare allows Omnyx to focus its innovation on the needs of anatomic pathologists worldwide. OmnyxTM products are for in vitro diagnostic use for specific clinical applications, and are intended for research use only on other applications. For more information, go to: omnyx.com.

About Real Time Medical
Real Time Medical is a diagnostic imaging workflow innovation company. It develops vendor-neutral, context-aware workflow management software solutions. These solutions organize the reporting services in complex diagnostic imaging organizations more efficiently and productively. Real Time Medical’s platform, DiaShareTM, improves the quality and accuracy of service delivery to patients. Real Time Medical also operates the only nationwide, round-the-clock radiology service in Canada, using its own context-aware workflow management software. For more information, visit http://www.realtimemedical.com.

About UPMC
A world-renowned health care provider and insurer, Pittsburgh-based UPMC is inventing new models of accountable, cost-effective, patient-centered care. It provides more than $887 million a year in benefits to its communities, including more care to the region’s most vulnerable citizens than any other health care institution. The largest nongovernmental employer in Pennsylvania, UPMC integrates more than 62,000 employees, 21 hospitals, 400 doctors’ offices and outpatient sites, a nearly 2.3-million-member health insurance division, and international and commercial operations. Affiliated with the University of Pittsburgh Schools of the Health Sciences, UPMC ranks No. 10 in the prestigious U.S. News & World Report annual Honor Roll of America’s Best Hospitals — and No. 1 in Pennsylvania. For more information, go to UPMC.com.

BOSTON, MA – The GE Foundation is announcing the final piece of its groundbreaking $25 million commitment to global safe surgery by supporting the expansion of Safe Surgery 2020 into Southeast Asia, with the inclusion of Cambodia and Lao People’s Democratic Republic. The investment is critical to accelerating access to surgical care in Southeast Asia as the region has one of the lowest levels of surgical provision in the world, with 97% of people currently unable to access safe surgical care.

At the 73rd Session of the United Nations General Assembly, GE Foundation officially partnered with Cambodia’s Ministry of Health to strengthen surgical systems through Safe Surgery 2020’s programs on workforce development and targeted innovations and equipment support. Safe Surgery 2020 will collaborate with Calmette Hospital and the University of Health Sciences to develop a training hub that will develop the surgical workforce.

“Safe Surgery 2020 is strengthening the foundations of the surgical system so that essential surgical care will become safe and accessible. The initiative will focus on building the capacity of Cambodian institutions to continue transforming surgical care long into the future,” said Ann R. Klee, President, GE Foundation. “The Cambodian government is committed to improving quality and increasing access to health care in the country, and GE Foundation is pleased to be collaborating with the Ministry of Health to advance surgical care.”

“We are delighted to be selected as one of the first countries in Southeast Asia to run the Safe Surgery program. It provides new, exciting training opportunities for our current, and aspiring surgeons – it will also further support, and hopefully speed up the roll out of a universal health coverage program in the near-future,” said HE Prof. Mam Bunheng, Minister of Ministry of Health.

Safe Surgery 2020 was established in 2015 with the goal of reducing preventable deaths and accelerating access to safe surgery and anesthesia worldwide. Safe Surgery 2020’s key objectives are:
Impact: Reduce preventable deaths from surgically-treatable conditions by enhancing quality of care and increasing the surgical volume in Safe Surgery 2020-supported facilities;
Innovation: Introduce and test innovative models for implementation in global health; and
Scale: Build and strengthen sustainable ecosystems for essential and emergency surgery in low-resource areas.

Safe Surgery 2020 launched in Ethiopia in 2016, and in Tanzania in 2017. The initiative has supported the Ethiopian and Tanzanian governments to develop national surgical strategies, known respectively as Saving Lives through Surgery, and the National Surgical, Obstetric and Anesthesia Plan. Through the portfolio of Safe Surgery 2020 programs, specific primary hospitals have increased surgical volume by 50% and decreased mortality and infection rates by up to a third. Reaching over 1200 workers in East Africa already, Safe Surgery 2020 empowers surgical teams to work well together, follow best practices like the WHO safe surgery checklist, better repair and sterilize surgical equipment.

GE Foundation’s investment in surgery in Southeast Asia builds on over ten years of work in region to improve underserved and rural communities’ access to quality healthcare. Over that time, GE and GE Foundation has provided $12 million in funding to bring in modern medical equipment, develop an in-country biomedical engineering equipment technician training program (BMET) in collaboration with Duke University and Engineering World Health, and increase access to safe water by sponsoring water purification systems with training for healthcare facilities. The programs have supported more than 40 hospitals in 25 provinces.

“Safe Surgery 2020 complements well the GE Foundation-supported healthcare program we launched in Cambodia in 2009. While that initiative focused on providing medical essentials such as training, and equipment, to under resourced hospitals, this specialist skill focused program offers long-term benefits for our surgical teams nationwide,” said Dararith Lim, Country Leader, GE in Cambodia.

About Safe Surgery 2020:
Safe Surgery 2020 brings together innovations, global expertise, and local experience to make surgical care safe and accessible for all. Working across Africa and South Asia, the initiative trains the surgical workforce, supports governments to strengthen national surgical systems, and develops scalable solutions to infrastructure barriers. Safe Surgery 2020 is hosted by Dalberg, implemented by Jhpiego, Harvard’s Program in Global Surgery and Social Change, Assist International, and local professional societies and universities. The initiative was seeded by the GE Foundation. For more details on Safe Surgery 2020, visit: https://www.safesurgery2020.org/.

About the GE Foundation:
GE Foundation, the philanthropic organization of GE, is committed to transforming our communities and shaping the diverse workforce of tomorrow by leveraging the power of GE. GE Foundation is developing skills by bringing innovative learning in community health globally and STEM education, scaling what works, and building sustainable solutions. GE Foundation is inspiring others to act by connecting GE people with communities through matching gifts and United Way, leading on emerging issues such as the opiate crisis, and convening community leaders to maximize our impact. Learn more at www.gefoundation.com or follow us on Twitter at @GE_Foundation.

NISKAYUNA, NY and WASHINGTON D.C – Wednesday, September 5, 2018 – Could non-invasive devices replace drugs and regular insulin injections in the future treatment of diabetes? This is a central question a team of GE scientists are exploring as part of a research project with DARPA worth up to $2.9 million. GE researchers will be demonstrating the technology this week at DARPA’s D60 symposium in Washington, DC.

As part of the 3-year program, the GE Bioelectronic medicine team aims to demonstrate that a novel, non-invasive, stimulation technique can be used to reverse or treat diabetes in pre-clinical models, instead of the typical drugs associated with treatments today. The team hopes that the results indicate the ability to prevent the onset of metabolic dysfunction (associated with the onset of diabetes), and that the GE team can progress toward safely testing and applying this technology in the clinic.

“Today’s drug treatments and monitoring methods for diabetes can be uncomfortable and time consuming, and create side-effects for patients,” said Victoria Cotero, a PhD and Biologist at GE Global Research who contributes to the DARPA project. “Our project with DARPA aims to find a better alternative that treats diabetes with non-invasive medical devices without the side effects associated with drug treatments.”

This project is part of a growing body of research in the field of bioelectronic medicine that is exploring new ways to treat chronic diseases such as diabetes by using electronic devices to correct dysfunctions in the nervous system that are believed to be key contributing factors to these diseases. GE scientists have developed a novel, potentially breakthrough approach that could restore nerve signals to a healthy state using non-invasive devices that stimulate metabolic biosystems and produce drug-like effects, but with greater precision than traditional treatments, and with fewer side effects.

The GE Bioelectronic medicine team is located at GE’s Global Research Center in Upstate New York. This interdisciplinary team of scientists and engineers works at the intersection of biology, physics and engineering and has deep connections to other top academic and clinical collaborators in the field.

Recently, members of the GE team were part of groundbreaking work led by the Feinstein Institute for Medical Research to read and interpret nerve signals in the body. The projects with DARPA and Feinstein are part of a growing number of research initiatives that the Bioelectronic medicine team is exploring to transform the diagnosis, treatment and monitoring of diseases.

“Given GE’s decades of innovation in medical imaging modalities, our growing body of research and published work in biomedical research and our considerable network of academic and clinical collaborators, GE Global Research is in a unique position to help drive the emerging field of non-invasive neuromodulation and enable revolutionary new treatments for diabetes and other chronic diseases,” Chris Puleo, a GE biomedical engineer and principal investigator of the DARPA project said.

About GE Global Research
GE Global Research is GE’s innovation powerhouse where research meets reality. We are a world-class team of 1,000+ scientific, engineering and marketing minds (600+ Ph. Ds), working at the intersection of physics and markets, physical and digital technologies, and across a broad set of industries to deliver world-changing innovations and capabilities for our customers.

WASHINGTON, D.C. – GE Healthcare and HeartFlow, Inc. announced today at SCCT2017, the annual scientific meeting of the Society of Cardiovascular Computed Tomography, that they have entered into a global collaboration agreement with the goal of increasing the clinical availability and adoption of HeartFlow FFRct, a proprietary technology that helps clinicians diagnose and treat patients with suspected coronary artery disease (CAD). The collaboration will involve computed tomography (CT) scanners from GE Healthcare with HeartFlow® FFRct, the first and only non-invasive technology that provides insight into both the extent of CAD and the impact of the disease on blood flow to the heart. HeartFlow FFRct is designed to enable clinicians to select a definitive, personalized treatment plan for each patient and reduce the need for additional invasive testing. The agreement will initially focus on the United States, with plans to expand into other markets in the future.

CAD, which affects 16.8 million people in the United States,[i] develops when the coronary arteries narrow, reducing blood flow to the heart and causing angina (chest pain), myocardial infarction (heart attack) and death.

“GE has collaborated with HeartFlow over the last five years, and this agreement reinforces our joint commitment to patients worldwide,” said Scott Schubert, general manager, Global Premium CT, GE Healthcare. “Along with our industry-leading cardiac CT systems and clinical applications, GE can now offer HeartFlow FFRct as an option for healthcare providers who strive to deliver the highest standards in clinical care while reducing costs.”

“This agreement with GE will help bring our game-changing non-invasive technology into the mainstream of cardiac care at thousands of hospitals that are already using state-of-the-art CT systems from GE, which provide exceptional image quality,” said John H. Stevens, M.D., president and chief executive officer of HeartFlow. “By collaborating, we can ensure that HeartFlow FFRct can be easily integrated into existing CAD protocols and more readily transform the care of patients with suspected and potentially life-threatening CAD.”

Diagnosing CAD Definitively and Non-Invasively with GE and HeartFlow
Clinicians diagnosing a patient with suspected CAD want to know as definitively as possible if the patient has a significant blockage in their coronary arteries and the impact of that blockage on blood flow to best determine which treatment pathway is appropriate (e.g., medical management, stenting or coronary artery bypass graft).

With HeartFlow FFRct, data from a patient’s non-invasive coronary CT angiogram are securely uploaded from the hospital’s system to the cloud. Then, HeartFlow leverages deep learning to create a personalized, digital 3D model of the patient’s coronary arteries and uses powerful computer algorithms to solve millions of complex equations to simulate blood flow in the model and assess the impact of blockages on coronary blood flow. The results are provided to the patient’s clinician via a secure web interface to offer actionable information on the optimal course of treatment.

GE brings to the collaboration its leading portfolio of cardiac CT solutions, including:
The Revolution™ family of CT scanners, with innovations including One-Beat Cardiac, SnapShot Freeze intelligent motion correction, and High Definition (HD) imaging with the industry’s highest cardiac spatial resolution;
CardioGraphe™, the world’s first dedicated cardiovascular CT system, a whole-heart coverage CT system that is affordable and accessible; and
AW advanced clinical applications including CardIQ, VesselIQ and TAVI planning to enhance physician diagnostic accuracy and productivity.

Together, the combination of GE and HeartFlow technologies promises to become an important way to assist in diagnosing CAD and guiding appropriate treatment. This combination also could help reduce unnecessary and invasive diagnostic coronary angiography procedures, which can be associated with serious complications, such as bleeding, stroke and major blood vessel damage.[ii]

About GE Healthcare
GE Healthcare provides transformational medical technologies and services to meet the demand for increased access, enhanced quality and more affordable healthcare around the world. GE (NYSE: GE) works on things that matter – great people and technologies taking on tough challenges. From medical imaging, software & IT, patient monitoring and diagnostics to drug discovery, biopharmaceutical manufacturing technologies and performance improvement solutions, GE Healthcare helps medical professionals deliver great healthcare to their patients. For more information about GE Healthcare, visit our website at www.gehealthcare.com.

About HeartFlow, Inc.
HeartFlow, Inc. is transforming the way cardiovascular disease is diagnosed and treated. The company’s HeartFlow FFRct is the first available non-invasive solution that enables a physician to more accurately evaluate whether a patient has significant coronary artery disease (CAD) based on both anatomy and physiology. HeartFlow FFRct, which leverages deep learning to create a personalized 3D model of the patient’s arteries, is well positioned to become an integral part of the standard of care for patients who are at risk for CAD because of its potential to improve both clinical outcomes and the patient experience while reducing the cost of care. HeartFlow FFRct is commercially available in the United States, Canada, Europe and Japan. For more information visit www.heartflow.com.

Stockholm, Sweden – 19 December 2014 – GE Healthcare has signed one of the largest and most complete cyclotron and radiochemistry system agreements in the world with Stockholm County Council and Karolinska University Hospital, Sweden. GE Healthcare will be building a complete tracer production facility center for the hospital that will significantly expand its capacity to manufacture PET tracers, a fundamental element in PET scanning that is most commonly used in the diagnosis and assessment of cancer. With the new center the hospital will achieve three to four times higher PET tracer production capacity compared to today, and it will support the development of new tracers.

The production facility will give the physicians and patients at Karolinska University Hospital readily available access to all commonly used PET tracers in clinical practice. The main area of application of the produced tracers is cancer treatment – by injecting a small amount of PET tracer into a patient followed by a PET scan, potential ‘hot spots’ can be revealed, the parts in the patient’s body where the distribution of tracers can be used for the assessment of metabolic activity associated with cancer.

“The wider availability of PET imaging technology and its benefits for early diagnosis and staging of diseases has grown the interest and demand for new PET tracers. We are entering a new era in molecular medicine with targeted tracers for specific diseases and personalized treatment pathways. The new centre at Karolinska will help them improve patient care,” said Karl Blight, General Manager, GE Healthcare, Northern Europe.
Besides cancer, the tracers can be used in the mapping and treatment of cardiovascular and neurological diseases, and they have an increasingly important role especially in Alzheimer’s, dementia and brain research.

The new tracer center includes two PETtrace 800 Series Cyclotron systems (for cyclotron production), 20 hot cells supporting radiation safety for personnel when they are using the equipment and fully automated and easily programmable TRACERlab* FX series chemistry synthesizers that will enable the hospital to monitor the tracer production remotely. The agreement also includes a FASTlab* Platform for multi-tracer production that makes the production of different tracers on the same hardware possible.

Karolinska University Hospital will also receive a broad range of technical trainings over the entire contract period and resources for joint innovation projects. The contract is signed to cover delivery, installation and qualification of the equipment, warranty and service contracts for three years, with an option to be extended by further two two year periods.

*Trademark of General Electric Company
Uppsala is home to the global headquarters of GE Healthcare’s cyclotron unit, where cyclotrons are developed, manufactured and serviced by more than 100 employees. In addition, GE Healthcare Life Sciences has around 1200 employees in Uppsala, of which over 450 people are working with production and research & development. It is a center of expertise in protein science and creates technology that pharmaceutical companies can use in the production of biopharmaceuticals, such as insulin, antibodies and vaccines.

About GE Healthcare
GE Healthcare provides transformational medical technologies and services to meet the demand for increased access, enhanced quality and more affordable healthcare around the world. GE (NYSE: GE) works on things that matter – great people and technologies taking on tough challenges. From medical imaging, software & IT, patient monitoring and diagnostics to drug discovery, biopharmaceutical manufacturing technologies and performance improvement solutions, GE Healthcare helps medical professionals deliver great healthcare to their patients. For more information about GE Healthcare, visit our website at www.gehealthcare.com.

Orlando – GE Healthcare (NYSE:GE) is working with Preventice Solutions to give clinician tools to follow patients with known or suspected Atrial fibrillation virtually from hospital to home. Atrial fibrillation, or AF, is an irregular and often rapid heart rate that can increase risk of stroke, heart failure and other heart-related complications, and, as the population ages globally, AF is predicted to affect 6 to 12 million people in the United States alone by 2050.

The collaboration offers a single vendor solution that is integrated with MUSE for seamless order-to-reporting workflow. According to U.S. News & World Reports, 24 out of 25 top U.S. cardiac hospitals use MUSE.[i] By integrating with MUSE, data from home-based patients will be made available to clinicians on the same clinical workspace they use every day.

“This development in our relationship with Preventice creates an integrated, longitudinal view of the patient experience,” said GE Healthcare Diagnostic Cardiology General Manager Ashutosh Banerjee. “We’re enabling the ECG record to grow with a richness that will allow the clinician to see how her treatment is working for the patient at home.”

‎“This partnership is transforming connected care in the industry with our customers benefiting from a ‎consistent patient experience with enhanced clinical insight,” said Preventice Solutions Chief Executive ‎Officer Jon Otterstatter. “This alliance will help standardize the operations and workflow for healthcare ‎providers resulting in improved quality.”

GE Healthcare and Preventice Solutions are announcing this latest progression of their strategic relationship at HIMSS 2019, February 12 – 15, 2019 in Orlando.

About GE Healthcare
GE Healthcare is the $19 billion healthcare business of GE (NYSE: GE). As a leading provider of medical imaging, monitoring, biomanufacturing, and cell and gene therapy technologies, GE Healthcare enables precision health in diagnostics, therapeutics and monitoring through intelligent devices, data analytics, applications and services. With over 100 years of experience in the healthcare industry and more than 50,000 employees globally, the company helps improve outcomes more efficiently for patients, healthcare providers, researchers and life sciences companies around the world. Follow us on Facebook, LinkedIn, Twitter and The Pulse for latest news, or visit our website www.gehealthcare.com for more information.

About Preventice Solutions
Preventice Solutions is a leading developer of mobile health solutions and remote monitoring services that connect patients threatened by cardiac arrhythmias. Using insights to create revolutionary monitoring technologies, this tech-enabled, service-based approach can ultimately reduce the cost of care and improve health outcomes. The Preventice wearable portfolio includes the PatientCare Platform and BodyGuardian family. For more information please visit www.preventicesolutions.com.

PITTSBURGH, PA, — Omnyx, LLC, the digital pathology joint venture between University of Pittsburgh Medical Center (UPMC) and GE Healthcare, today announced a memorandum of understanding with Argent Global Services, a process engineering and management consulting firm, to help revolutionize the pathology laboratory. The agreement is intended to provide hospitals and academic research facilities with operational consulting and change management solutions that enhance workflow efficiency and enable seamless transition for adopting digital technologies in pathology labs.

Digital pathology is a new area for many pathologist labs that traditionally used microscopes to examine tissues. The increased occurrence of cancer in recent times has raised the urgency to embrace digital technologies as they have the potential to enhance clinical and operational results. Digital pathology has the ability to cut slide processing time by 25 percent[1]. The use of digital pathology also enables more collaboration with care teams, which studies has shown that seeking a second opinion or collaborating with the care team has the potential to improve the diagnosis and treatment plan in nearly one in 10 patients[2], [3].

“As pathology ushers in the new, digital era, we believe that its success will rely greatly on three key aspects – smart scanners, brilliant software and leveraging the full potential of these technologies with transformative consulting,” said Mamar Gelaye, CEO of Omnyx. “Collaborating with industry leaders, like Argent, allows us to strengthen our offering in each of these aspects, and is additional proof of our commitment to transform this critical field.”

Through this agreement, Omnyx will leverage Argent’s 20 years of consulting expertise to add a range of pilot offerings into its consulting portfolio around:
· Operations improvement
· Organizational change management for digital pathology
· Performance assessment and benchmarking

“Together, we aim to improve digital pathology workflow and, ultimately helping pathologists connect patients with the right treatment,” said Steve Stone, Managing Director of Argent. “As pathologists adjust to new scanning equipment and software, our joint consulting services will work with them to make a seamless transition, and transform the way in which their labs utilize smart scanners and brilliant software throughout the clinical process.”
The new offerings are expected to be available to customers through Omnyx later this year.

About GE Healthcare
GE Healthcare provides transformational medical technologies and services to meet the demand for increased access, enhanced quality and more affordable healthcare around the world. GE (NYSE: GE) works on things that matter – great people and technologies taking on tough challenges. From medical imaging, software & IT, patient monitoring and diagnostics to drug discovery, biopharmaceutical manufacturing technologies and performance improvement solutions, GE Healthcare helps medical professionals deliver great healthcare to their patients. www.gehealthcare.com

About Omnyx
Omnyx, LLC is a joint venture of GE Healthcare and UPMC (University of Pittsburgh Medical Center) with locations in Pittsburgh, PA and Piscataway, NJ. The company has developed the OmnyxTM IDP solution allowing pathology departments worldwide to move to an all-digital workflow. Their products include image acquisition devices, workflow software, and transformation consulting. Close collaboration with pathologists at UPMC and other institutions along with their relationship with GE Healthcare allows Omnyx to focus its innovation on the needs of anatomic pathologists worldwide. OmnyxTM products are for in vitro diagnostic use for specific clinical applications, and are intended for research use only on other applications. For more information, go to: omnyx.com.
About Argent
Founded in 1988, Argent Global Services is a recognized leader in the implementation of solutions that increase productivity, enhance service, improve quality, and reduce costs. Argent provides industrial engineering, software, training and management consulting solutions that enable clients to gain a competitive advantage in the global marketplace. Argent utilizes industry knowledge and real-world experience to deliver significant value for each client. http://argentglobal.com/

VIENNA, AUSTRIA – Growing its range of magnetic resonance imaging (MRI) contrast media options available to patients and radiologists, GE Healthcare today announced the launch of Clariscan™ (gadoteric acid) at the European Congress of Radiology (ECR) 2017 meeting. Clariscan is a gadolinium-based contrast agent (GBCA) designed to support effective visualisation of abnormalities in the brain, spine and associated tissues, and will be provided alongside GE Healthcare’s comprehensive support services and solutions to healthcare practitioners worldwide.

Emmanuel Ligner, General Manager of Core Imaging for GE Healthcare Life Sciences, said: “Gadolinium-based agents are known to be a gold-standard detection tool in MR imaging, offering improved contrast between normal and pathological tissue to enable rapid detection of abnormalities. It is important that radiologists are able to make a contrast media selection dependent on the needs of individual patients.”

“We are therefore pleased to add Clariscan to the family of GE contrast media and imaging products alongside our existing linear agent for MRI, Omniscan, which has been used in routine diagnostic practice for over 25 years with over 80 million administrations. We believe macrocyclic Clariscan, manufactured using a proprietary GE process, extends choice for radiology professionals, backed by the well-established quality, reliability and surrounding services GE customers have come to expect.”

As a macrocyclic and ionic GBCA, Clariscan is available at a range of doses in vials and pre-filled syringes. It is the latest in a line of products and services provided by GE Healthcare to the radiology community, which include a wide range of contrast media as well as a portfolio of systems and products across MRI, X-ray/CT and ultrasound modalities. GE Healthcare has provided comprehensive partnership and support services to the radiology profession for over 30 years.

Demand for contrast media has significantly increased over the past decade due to rapid procedural advancements in MR imaging, elevating the importance of uninterrupted and sustainable product supply, as well as meeting the individual needs of patients undergoing diagnostic procedures. The company invested over USD 65 million in its worldwide supply network between 2013 and 2016, to increase manufacturing capacity. GE contrast media products are used in more than 70 million procedures per year, equivalent to injection in two patients per second. The company provides best-in-class service and supply of its contrast media portfolio to radiologists across all medical, technical and logistical aspects of imaging.

Clariscan™ has been approved using the decentralised procedure with marketing authorisation in place in Norway. It will be introduced to European countries across 2017. Healthcare professionals are advised to speak to their local GE Healthcare representative for information on local availability.

About GE Healthcare
GE Healthcare provides transformational medical technologies and services to meet the demand for increased access, enhanced quality and more affordable healthcare around the world. GE (NYSE: GE) works on things that matter – great people and technologies taking on tough challenges. From medical imaging, software & IT, patient monitoring and diagnostics to drug discovery, biopharmaceutical manufacturing technologies and performance improvement solutions, GE Healthcare helps medical professionals deliver great healthcare to their patients. For more information about GE Healthcare, visit our website at www.gehealthcare.com.

GE Healthcare Life Sciences, a global tools, technologies and services provider in life science research and biopharmaceutical manufacturing, will open a Technology and Training Laboratory to support Turkey’s expanding biopharmaceutical and biotechnology industry. A key component of GE’s Turkey Innovation Center in Istanbul, the laboratory will open to customers, industry and academic partners from mid-2015. This adds to GE’s global network of biopharmaceutical customer training and technology facilities in the US, UK, China, India and Sweden.

The GE Healthcare Life Sciences Technology Laboratory will feature the company’s latest tools and technologies for drug discovery, protein science, and bioprocessing research. It will offer advanced technical training and technology evaluation to the Turkish biopharmaceutical sector, as well as being open to universities as a location for elements of biotechnology degree courses. Academics, pharmaceutical and biotechnology researchers will also have access to the laboratory for small scale research studies using the latest GE equipment, as will GE customers from the Middle East and Russia.

Turkey plans to expedite the transformation of its healthcare sector through domestic manufacturing of both devices and pharmaceuticals, with plans for local pharmaceutical manufacturing to represent 60% of the country’s consumption.

Highlighting the significance of the new facilities to the Turkish life sciences industry, Dr. Irem Yenice, Biotechnology Division Manager, Arven said, “The GE Healthcare Life Sciences Istanbul Technology and Training Laboratory is an excellent commitment to Turkey’s biotechnology goals, and will be very useful to Turkish research & development and industry. Connecting different scientific fields and helping to strengthen industrial applications, the laboratory could be an important support to growth and innovation in Turkey.”

Myra Eskes, GM, GE Healthcare Life Sciences Eastern & Africa Growth Markets said: “Our investment in the Istanbul Technology and Training Laboratory underscores GE’s commitment to supporting growth in life sciences and the biopharmaceutical industry in both Turkey and the region, complementing and strengthening academic and industry investments in biopharmaceutical research and manufacturing.”

About GE’s Turkey Innovation Center
The GE Turkey Innovation Center will be an interactive space where diverse ideas and people are encouraged, nurtured and connected to the wider innovation ecosystem across the country. The facility will have a strong focus on the Future of Work, with an Advanced Manufacturing lab, an in-depth look at the Industrial Internet, a dedicated Life Sciences Technology and Training lab, and content and resources to connect people around the globe.

About GE Healthcare
GE Healthcare provides transformational medical technologies and services to meet the demand for increased access, enhanced quality and more affordable healthcare around the world. GE (NYSE: GE) works on things that matter – great people and technologies taking on tough challenges. From medical imaging, software & IT, patient monitoring and diagnostics to drug discovery, biopharmaceutical manufacturing technologies and performance improvement solutions, GE Healthcare helps medical professionals deliver great healthcare to their patients. For more information about GE Healthcare, visit our website at www.gehealthcare.com.

Chalfont St. Giles, UK, – Broadening its range of diagnostic options for clinicians and their patients, GE Healthcare announced today that it has received an indication approval from the U.S. Food and Drug Administration (FDA) for its imaging agent Visipaque™ (iodixanol) Injection. Visipaque 320 mg Iodine/mL is an iso-osmolar agent that is now approved for use in coronary computed tomography angiography (CCTA) to assist in the diagnostic evaluation of adult and pediatric patients 12 years of age or older with suspected coronary artery disease in the United States.

The new CCTA indication allows healthcare practitioners to image the coronary arteries of patients with suspected coronary artery disease (CAD), offering a non-invasive approach to diagnosis. Traditionally, radiologists and cardiologists have utilized Invasive Coronary Angiography (ICA) procedures to diagnose potential CAD in patients, which can be costly and result in longer patient hospital stays. With Visipaque’s CCTA label extension, healthcare practitioners now have an FDA-approved contrast agent in CCTA procedures that can be performed as an outpatient procedure when evaluating patients with suspected CAD.

According to Matt Budoff, Professor of Medicine at UCLA, “Coronary heart disease is a major cause of death in the United States. We are excited about the label extension of Visipaque™ as the first FDA approved iodinated contrast media for use in CCTA. Having an approved contrast agent for CCTA may facilitate the use of CCTA as a gatekeeper to ICA in patients with mild to moderate coronary artery disease, sparing patients from a more invasive procedure and long recovery times.”

“Technology to image the coronary artery has improved dramatically over the past decade and we are delighted to complement these developments with an extension to the approved use of Visipaque,” said Emmanuel Ligner, General Manager of GE Healthcare’s Core Imaging business. “GE Healthcare is focused on continued innovation and investment in our contrast media portfolio to deliver a range of options for our customers and their patients, and we believe the CCTA label extension is an excellent development for patient care. “

Label extension approval for VISIPAQUE 320 mg Iodine/mL for CCTA was evaluated in two prospective, multicenter clinical studies in a total of 1,106 adult patients. Data from the two studies showed that Visipaque™ has a 99% negative predictive value in the diagnosis of CAD (study 1: sensitivity (76-89%), specificity (84-89%); study 2: sensitivity (95%), specificity (87%))[1]. Visipaque’s label extension further enhances GE Healthcare’s cardiology portfolio , joining, Myoview, Adreview, and the recently announced distribution rights for Rapiscan outside the US and Canada.

About GE Healthcare
GE Healthcare provides transformational medical technologies and services to meet the demand for increased access, enhanced quality and more affordable healthcare around the world. GE (NYSE: GE) works on things that matter – great people and technologies taking on tough challenges. From medical imaging, software & IT, patient monitoring and diagnostics to drug discovery, biopharmaceutical manufacturing technologies and performance improvement solutions, GE Healthcare helps medical professionals deliver great healthcare to their patients. For more information about GE Healthcare, visit our website at www.gehealthcare.com.

BANGALORE, INDIA, GE Healthcare, a unit of General Electric Company (NYSE: GE), reiterated its commitment towards ‘Make in India’ by strengthening its R&D, Manufacturing, Supply Chain, Distribution capabilities and Education initiative. With enhanced capabilities, GE today announced the launch of Revolution™ ACTs*, first Computed Tomography system designed and developed by GE Healthcare in India. The Revolution ACTs is manufactured in India for India and the world. The Revolution ACTs is the result of Rs.120 Crores investment and collaborative efforts of GE and Indian healthcare providers for over 4 years.

Speaking at the occasion, John Flannery, President and CEO of GE Healthcare, said, “Make in India means much more than local manufacturing for us at GE Healthcare. It is a 360 degree thrust starting with designing and developing relevant solutions in partnership with our users; robust engineering of technologies; developing a world class supply chain, advanced manufacturing, expert user training and developing a network for distribution as well as maintenance of these solutions in the remotest parts of the country and world. It represents our commitment to work towards making quality healthcare truly accessible and affordable for India as well as the world. “

“We are proud that our first ever locally designed CT technology – Revolution ACTs is developed by the people of India, for the people of India. It is a testament to India’s intellectual, design and advanced manufacturing capabilities.” added Terri Bresenham, President& CEO of GE Healthcare South Asia.

Healthcare in India is under-served and under-consumed with its skewed imbalance in resources. India faces severe shortfall of both hard infrastructure and skilled talent, especially in Tier II-IV towns. While disruptive technologies have the potential to enhance infrastructure and care delivery, adoption of same has been restricted due to a number of factors like affordability, knowledge about its clinical utility, distribution, service, funding etc. For over 2 decades GE Healthcare has been innovating and making in India to enhance affordability and access of healthcare solutions. GE Healthcare has recently formed a new national network – GenWorks Health Pvt. Ltd and is endeavoring to address these severe challenges faced by healthcare providers in Tier II-IV towns. GenWorks has commenced operations with 150 highly experienced team members with each member having an average industry and leadership experience of 17 years. GenWorks is rapidly building presence in 450 tier II-IV towns to take disruptive technologies, training and support closer to healthcare providers in a bid to give these first time users a high quality user experience.

“All initiatives to develop relevant technologies would be meaningless if they are not accessible to all and hence we also invested and built a national network. GenWorks Health Pvt Ltd will help us take these technologies to the grass root level and provide world-class training and support for doctors to ensure technology can benefit patient outcomes. Healthier India cannot be built in isolation and hence GE Healthcare is looking at an all-inclusive approach to achieve this. With GenWorks, we are stepping up our efforts to elevate the standard of healthcare services in tier II/III cities and towns through this new venture “said Terri Bresenham.

For over 25 years, GE Healthcare has been working extensively towards a healthier India through innovating in India, making in India and now skilling India. GE Healthcare has strengthened R&D facility with the inclusion of a Global Design Studio called eCube. The studio serves the vital role of a stage for immersive research and collaborative co-creation of disruptive technologies with willing healthcare providers as partners. Revolution ACTs is the result of 4 years of research and development by 75 GE scientists and engineers in collaboration with over 500 healthcare providers from both urban and rural settings. The Revolution ACTs also achieved a remarkable feat of 5 global patents for its design and engineering.

“Revolution ACTs is a journey into the needs of new users of CT in smaller towns. It’s about innovating for affordability and defining solutions that deliver high quality diagnostic CT solutions in the most challenging healthcare markets. We hope to place one Revolution ACTs per district to improve access to quality diagnosis “said Milan Rao, Chief Operating Officer, GE Healthcare, India & South Asia.

Revolution ACTs is 40% more affordable compared to previous generation 4 slice CT systems. The total life cycle cost of Revolution ACTs is further reduced by its 8m2 compact footprint leading to 45% lower siting cost and 47% savings in electricity consumption. Making in India will bring in additional cheer to Indian healthcare providers – faster delivery, faster response and reduced import duties. Revolution ACTs introduces Clarity panel detector, exclusively developed for this product to improve image resolution, along with Smart Dose technologies to lower radiation dose by up to 36% while preserving high image quality. It hosts an efficient digital workflow and an user interface that is easy to learn and use for even a first time user.

GE has developed a world class supplier base in India as well as facilities for assembly and testing. Over 30% of the product components and parts are either in-house manufactured or sourced from India and includes the heart of the machine – Generator and Tubes. GE is the first company to manufacture advanced healthcare imaging technologies in India with its first factory set up in Bangalore in 1991. Today, GE Healthcare has three dedicated, world class manufacturing plants in Bangalore with over 400,000 sq. ft of manufacturing space that has produced over 200,000 units of medical technologies for the world. GE has been recognized as the largest medical electronics exporter for 11 consecutive years.

CT is one of the most valuable diagnostic tools in emergency rooms as well as in the diagnosis of several health conditions like Stroke, Trauma etc. with its rapid imaging capability for quick diagnosis. India has one of the highest prevalence of diseases like Stroke with 1.6 Mn new cases every year leading to 0.63 Mn deaths. India also accounts for largest accidents and trauma conditions with 1 accident per minute and 1 death every 3.7 minutes. One third of accident victims can be saved with speedy hospitalization and trauma care. However, in India, we have limited penetration of this important technology – 3 CT systems per million populations compared to 20 CT systems per million population in developed markets. An ACT can be the change.

As per a recent Bain & Company report, India has made noteworthy progress and is healthier today than ever, but the country still struggle with substantial issues and gaps in its healthcare system. Healthcare in India is under-served and under-consumed with its skewed imbalance in resources. India faces severe shortfall of both hard infrastructure and skilled talent today. India imports over 75% of its medical technologies and devices today making accessibility and affordability a challenge. Many healthcare providers are forced to opt for low quality, used and sometimes obsolete technologies that leads to poor quality diagnosis and costly downtimes. Now is an opportune time to re-define India’s healthcare system in order to power India’s economic growth. Co-creating relevant technologies in India for India can lead to increased adoption to deliver quality healthcare everywhere. India can emerge as an innovation hub for disruptive technologies and quality manufacturing.
About GE Healthcare: GE Healthcare provides transformational medical technologies and services to meet the demand for increased access, enhanced quality and more affordable healthcare around the world. GE (NYSE: GE) works on things that matter – great people and technologies taking on tough challenges. From medical imaging, software & IT, patient monitoring and diagnostics to drug discovery, biopharmaceutical manufacturing technologies and performance improvement solutions, GE Healthcare helps medical professionals deliver great healthcare to their patients.

GE Healthcare is at work for a healthier India and is focusing on some of the toughest healthcare challenges faced by India today – lowering maternal and infant deaths, enabling early detection of cancer for early treatment, addressing heart diseases early, etc. GE Healthcare pioneered innovation of healthcare imaging technologies in India for India and the world to enhance access to quality healthcare at affordable costs to more people. GE Healthcare operates in India through a joint venture namely Wipro GE Healthcare Private Limited. For the latest news, please visit http://newsroom.gehealthcare.com

About GE in India: Present in India since 1902, GE works to innovate, partner and develop technology solutions in energy, healthcare, infrastructure, aviation and financial services that improve the quality of life in the country. With over 13,000 employees, GE’s imagination is taking the nation to the future with ideas designed and developed in India – for India and for the rest of the world.
With more than 5,300 technologists, GE’s research centers in Bangalore, Hyderabad, Mumbai and Chennai are developing new technologies for both India and the world, while the 10 local manufacturing facilities bring products, services and technologies closer to customers. GE in India has partnered with a number of Indian companies to develop localized solutions, meeting the needs of the country. Committed to social development, GE in India is closely engaged with local communities on social and environmental issues.

GENEVA, 3 December – As world leaders gather virtually at the Special Session of the General Assembly in response to the COVID-19 pandemic, new data published today finds that leaving low- and lower-middle-income countries (LLMICs) without access to vaccines amid the COVID-19 pandemic will cause significant economic damage that puts decades of economic progress at risk – for both LLMICs and advanced economies alike.

The report by the Eurasia Group analyses ten major economies – Canada, France, Germany, Japan, Qatar, South Korea, Sweden, United Arab Emirates, United Kingdom and the United States – to assess the economic benefits to advanced economies of contributing to the work of the Access to COVID-19 Tools (ACT) Accelerator.

The ACT Accelerator, led by WHO and partnering with the world’s leading international health organizations, is a unique global collaboration which supports the development and equitable distribution of the tests, treatments and vaccines the world needs to fight COVID-19. However, the programme still has a significant funding gap of US$28.2 billion – with $US 4.3 billion needed urgently to fast-track critical areas of work. If that shortfall isn’t met, low- and low-middle income countries will have delayed access to these vital tools in 2021, which will result in a protracted pandemic, with severe economic consequences, not just for these countries by also for the wider global economy.

The report, which was commissioned by the Bill & Melinda Gates Foundation, finds that the economic benefits of a global equitable vaccine solution alone for the 10 countries included in the analysis would be at least $153 billion in 2020-21, rising to $466 billion by 2025. This is more than 12 times the $38 billion estimated total cost of the ACT Accelerator. This figure was compiled using the expected negative effects of sustained coronavirus outbreaks in LLMICs, based on the downside and baseline scenarios of the IMF’s October 2020 World Economic Outlook forecasts.

So far, the 10 countries featured in the report have contributed $2.4 billion to the work of the ACT Accelerator, with the U.K. committing just over US$ 1 billion, and Germany, Canada, Japan and France committing US$ 618 million, US$ 290 million, US$ 229 million and US$ 147 million respectively.

In just seven months, the ACT Accelerator’s progress has been significant: over 50 diagnostic tests have been evaluated and new rapid antigen diagnostics have been developed and being made available for LMICs; life-saving Dexamethasone treatments are being rolled out, research into monoclonal antibody treatments is advancing; and through the Health Systems Connector, the health system requirements for delivery of COVID-19 tools have been mapped in 4 out of 6 world regions.

COVAX, the Vaccines Pillar of the ACT Accelerator, has the world’s largest and most diverse portfolio of vaccines. It aims to accelerate the development and manufacture of COVID-19 vaccines, and to guarantee fair and equitable access for every participating country. Working with 189 countries, COVAX is supporting the development of 9 vaccine candidates through CEPI, 8 of which are in clinical trials. COVAX has secured hundreds of millions of doses of three promising candidates, including at least 200 million doses for LICs, with the support of the Bill & Melinda Gates Foundation.

This new report emphasizes the funding urgency and the return on investment for donor countries of the work of the ACT Accelerator, which published its Urgent Priorities and Financing Requirements on 10 November.

Dr Tedros Adhanom Ghebreyesus, WHO Director-General, called on countries to commit to the work of the ACT Accelerator, stating that, “The ACT Accelerator is the global solution to ending the acute phase of the pandemic as quickly as possible by ensuring equitable access to COVID-19 tools. Contributing to the ACT Accelerator it is not just the right thing to do – it’s the smart thing for all countries – socially, economically and politically.”

Alexander Kazan, Managing Director for Global Strategy at Eurasia Group and one of the authors of the report said, “There is a clear humanitarian and ethical case for supporting the ACT Accelerator and the Covax facility, along with the obvious economic gains it would bring to developing countries; doing nothing risks reversing years if not decades of economic progress. But our analysis shows that the program is likely to yield economic and other returns for major donor countries as well. The ACT Accelerator is a unique opportunity to save lives, repair the global economy, and build diplomatic capital that will last a generation.”

Hassan Damluji, Deputy Director at the Bill & Melinda Gates Foundation, commenting on the report’s findings said, “The moral case for an equitable global solution to the COVID-19 crisis has always been clear, but with high-income countries reeling from a huge shock, their governments are increasingly focusing on investments that can help their own economies to rebound. This report adds to the body of evidence that shows that the ACT Accelerator is precisely one of those investments. It is both the right thing to do, and an investment that will pay dividends by bringing the global economy back from the brink, benefiting all nations.”

Eurasia Group
Eurasia Group is the world’s leading global political risk research and consulting firm. By providing information and insight on how political developments move markets, we help clients anticipate and respond to instability and opportunities everywhere they invest or do business. Our expertise includes developed and developing countries in every region of the world, specific economic sectors, and the business and investment playing fields of the future. With our best-in-class advisory and consulting offerings and GZERO Media, the Eurasia Group umbrella provides the marketplace with a complete political risk solution. Headquartered in New York, we have offices in Washington DC, London, San Francisco, Brasilia, Sao Paulo, Singapore, and Tokyo, as well as on-the-ground experts and resources in more than a hundred countries. “Politics first” grounds our work: Politics is the lens through which we view the world, and we are committed to analysis that is free of political bias and the influence of private interests.

The ACT Accelerator
The Access to COVID-19 Tools Accelerator (ACT Accelerator), is the proven, up-and-running global collaboration to accelerate the development, production, and equitable access to COVID-19 tests, treatments, and vaccines. It was set up in response to a call from G20 leaders in March and launched by the WHO, European Commission, France and The Bill & Melinda Gates Foundation in April 2020.

The ACT Accelerator is not a decision-making body or a new organization, but works to speed up collaborative efforts among existing organizations to end the pandemic. It is a framework for collaboration that has been designed to bring key players around the table with the goal of ending the pandemic as quickly as possible through the accelerated development, equitable allocation, and scaled up delivery of tests, treatments and vaccines, thereby protecting health systems and restoring societies and economies in the near term. It draws on the experience of leading global health organizations which are tackling the world’s toughest health challenges, and who, by working together, are able to unlock new and more ambitious results against COVID-19. Its members share a commitment to ensure all people have access to all the tools needed to defeat COVID-19 and to work with unprecedented levels of partnership to achieve it.

The ACT Accelerator comprises four pillars: diagnostics, therapeutics, vaccines and health system strengthening.

The diagnostics pillar, co-convened by the Global Fund and FIND is focused on bringing to market 2–3 high-quality rapid tests, training 10,000 healthcare professionals across 50 countries and establishing testing for 500 million people in Low and Middle-Income countries by mid-2021.
The therapeutics pillar is led by Unitaid and Wellcome. Therapeutics can play a role in all stages of COVID-19 disease: to prevent infection; suppress symptoms and spread of infection to others; treat or prevent symptoms; as a life-saving treatment for severe symptoms; and as a treatment that can speed up recovery. The aim in the next 12 months is to develop, manufacture and distribute 245 million treatments, helping COVID-19 sufferers to recover from the disease.

The COVAX vaccines pillar, convened by CEPI, Gavi and WHO, is speeding up the search for an effective vaccine for all countries. At the same time, it is supporting the building of manufacturing capabilities, and buying supply, ahead of time so that 2 billion doses can be fairly distributed by the end of 2021.

The health systems connector, led by the WHO, World Bank and the Global Fund, is working to ensure that these tools can reach the people who need them.

Cross-cutting all of these is the workstream on Access & Allocation, hosted by the World Health Organization (WHO).

ADDIS ABABA, Ethiopia, July 13, 2015—The United Nations, the World Bank Group, and the Governments of Canada, Norway and the United States joined country and global health leaders today to launch the Global Financing Facility (GFF) in support of Every Woman Every Child, and announced that $12 billion in domestic and international, private and public funding has already been aligned to country-led five-year investment plans for women’s, children’s and adolescents’ health in the four GFF front-runner countries of the Democratic Republic of the Congo, Ethiopia, Kenya and Tanzania.

Launched at the Third International Financing for Development Conference, the GFF is a key financing platform in support of the United Nations Secretary-General’s Global Strategy for Women’s, Children’s and Adolescents’ Health and the Sustainable Development Goals.

At the launch, the World Bank Group announced a new GFF partnership with its International Bank for Reconstruction and Development (IBRD) to raise funds from capital markets for countries with significant funding gaps for reproductive, maternal, newborn, child and adolescent health (RMNCAH). This ground-breaking partnership expects to mobilize between $3 to $5 dollars from the private capital markets for every $1 dollar invested into the GFF. The Government of Canada is jumpstarting this initiative with a $40 million investment towards two focus areas: one that prioritizes strengthening front-line health systems and scaling-up of community health workers, and another that focuses on the control of malaria to reduce child mortality.

The Bill & Melinda Gates Foundation, Canada, Japan, and the United States announced new financing commitments totalling $214 million. This is in addition to commitments previously made by Norway and Canada of $600 million and $200 million, respectively, to the World Bank Group-managed GFF Trust Fund.

The GFF has set in motion an unprecedented movement among countries, United Nations agencies and multilateral agencies including the World Bank Group, the Global Fund to Fight HIV/AIDS, Tuberculosis and Malaria, and Gavi, the Vaccine Alliance, as well as public and private sector financiers and civil society organizations, to increase and align funding in support of countries’ health priorities and plans, to drive transformative improvements in the health of women, children and adolescents everywhere. Today’s announcements are a first step to help close the $33.3 billion annual funding gap for RMNCAH.

The GFF partners also announced the next group of eight countries to benefit from the GFF, with the goal of supporting 62 high-burden low- and lower-middle income countries within five years. The GFF is adding Bangladesh, Cameroon, India, Liberia, Mozambique, Nigeria, Senegal and Uganda as the second wave of GFF countries.

New GFF-IBRD Partnership to Leverage Private Sector Investments for Maternal, Child and Adolescent Health

A key aim of the GFF is to mobilize private sector resources that, in addition to public sector resources, help close gaps in the financing of essential interventions required to improve the health of women, children and adolescents. To this end, the GFF is partnering with the World Bank Group’s IBRD to raise funds from capital markets for countries with significant funding gaps for RMNCAH.

The IBRD finances its lending activities by issuing bonds in the capital markets, leveraging its equity to bring in private sector financing for sustainable development. The new GFF-IBRD partnership will mobilize the capital markets for better outcomes for maternal child and adolescent health, by using the overall IBRD funding platform, issuing Sustainable Development Bonds with a health focus, and designing innovative risk-sharing structures.

The Government of Canada’s $40 million investment to jumpstart this partnership and leverage funding from private capital markets will be directed toward investments in two focus areas: one that prioritizes strengthening front-line health systems and scaling-up of community health workers, and another that focuses on the control of malaria to reduce child mortality. These monies will be used as performance payments to countries, due upon the achievement of agreed-to outcomes, significantly reducing countries’ borrowing costs while incentivizing performance. Further investments in this partnership will unlock significantly more resources from the private sector, with an objective of raising up to $1 billion in private capital.

In support of Every Woman Every Child, the Bill & Melinda Gates Foundation is committing $75 million over five years to the GFF Trust Fund to advance the Global Strategy for Women’s, Children’s and Adolescents’ Health.

The GFF Trust Fund is catalyzing the work of the broader facility by providing grants to countries linked to World Bank Group loans for health and supporting countries to prepare health financing strategies that anticipate the transition of countries from low- to middle-income status. The GFF Trust Fund aims to secure universal access to essential services for every mother and every child by ensuring that official development assistance does not displace domestic resources for the sector and charting a path to sustainable domestic financing for health.

Other GFF partners are making commitments through in-country financing for country-led maternal and child health investment plans. This includes a US$50 million commitment to the GFF from the U.S. Agency for International Development. This funding will support the Democratic Republic of the Congo, Ethiopia, Kenya and Tanzania to scale up national strategies and efforts to end preventable child and maternal deaths. The Government of Japan pledges $33 million to support maternal and child health initiatives in Kenya.

In addition, Canada commits $16 million for the start-up and establishment of a global Centre of Excellence for strengthening civil registration and vital statistics, in support of the GFF’s efforts to contribute to universal registration by 2030. By improving the quality and availability of data on every birth, death, cause of death and marriage, GFF-supported countries will be able to better monitor and track their investments in maternal, newborn and child health.

GBCHealth, a coalition of companies and organizations investing their resources to make a healthier world, is committing to raise capital for the GFF from its network of companies through its Health Credit Exchange, a new performance-based funding initiative.

About the Global Financing Facility in Support of Every Woman Every Child

The GFF is a key financing platform of the United Nations Secretary-General’s Global Strategy for Women’s, Children’s and Adolescents’ Health. It is a country-driven financing partnership that brings RMNCAH stakeholders together, under national government leadership and ownership, to provide smart, scaled and sustainable financing to accelerate efforts to end preventable maternal, newborn, child and adolescent deaths by 2030.

The child mortality rate in low-income countries is more than 15 times higher than in high-income countries. And maternal mortality is nearly 30 times higher. Yet, with over 100 million children’s lives saved since 1990, the Lancet Commission on Investment and Health documented the feasibility of a grand convergence in mortality between low-income countries and the best-performing middle-income countries, with a return of nine to 20 per dollar invested.

The GFF will be a key driver of this convergence. Its results framework will be aligned with the Global Strategy’s results frameworks and with the new Sustainable Development Goals.

The GFF is an essential part of the paradigm shift in development financing, emphasizing the essential but changing role of official development assistance in unlocking domestic resources and private flows and focusing on results. It has the potential to act as a pathfinder for financing the SDGs in the post-2015 era.

MOUNTAIN VIEW, CA – September 18, 2013 – Google today announced Calico, a new company that will focus on health and well-being, in particular the challenge of aging and associated diseases. Arthur D. Levinson, Chairman and former CEO of Genentech and Chairman of Apple, will be Chief Executive Officer and a founding investor.

Announcing this new investment, Larry Page, Google CEO said: “Illness and aging affect all our families. With some longer term, moonshot thinking around healthcare and biotechnology, I believe we can improve millions of lives. It’s impossible to imagine anyone better than Art—one of the leading scientists, entrepreneurs and CEOs of our generation—to take this new venture forward.” Art said: “I’ve devoted much of my life to science and technology, with the goal of improving human health. Larry’s focus on outsized improvements has inspired me, and I’m tremendously excited about what’s next.”

Art Levinson will remain Chairman of Genentech and a director of Hoffmann-La Roche, as well as Chairman of Apple.

Commenting on Art’s new role, Franz Humer, Chairman of Hoffmann-La Roche, said: “Art’s track record at Genentech has been exemplary, and we see an interesting potential for our companies to work together going forward. We’re delighted he’ll stay on our board.”

Tim Cook, Chief Executive Officer of Apple, said: “For too many of our friends and family, life has been cut short or the quality of their life is too often lacking. Art is one of the crazy ones who thinks it doesn’t have to be this way. There is no one better suited to lead this mission and I am excited to see the results.”

This Press Release is courtesy of ww.google.com

GSK (LSE/NYSE: GSK) today announced an agreement with Verily Life Sciences LLC (formerly Google Life Sciences), an Alphabet company, to form Galvani Bioelectronics to enable the research, development and commercialisation of bioelectronic medicines. GSK will hold a 55% equity interest in the new jointly owned company and Verily will hold 45%.

Galvani Bioelectronics will be headquartered in the UK, with the parent companies contributing existing intellectual property rights[1] and an investment of up to £540 million over seven years, subject to successful completion of various discovery and development milestones.

Bioelectronic medicine is a relatively new scientific field that aims to tackle a wide range of chronic diseases using miniaturised, implantable devices that can modify electrical signals that pass along nerves in the body, including irregular or altered impulses that occur in many illnesses. GSK has been active in this field since 2012 and believes certain chronic conditions such as arthritis, diabetes and asthma could potentially be treated using these devices.

The agreement to establish Galvani Bioelectronics represents an important next step in GSK’s bioelectronics research. The new company will bring together GSK’s world class drug discovery and development expertise and deep understanding of disease biology with Verily’s world leading technical expertise in the miniaturisation of low power electronics, device development, data analytics and software development for clinical applications. Initial work will centre on establishing clinical proofs of principle in inflammatory, metabolic and endocrine disorders, including type 2 diabetes, where substantial evidence already exists in animal models; and developing associated miniaturised, precision devices.

Moncef Slaoui, GSK’s Chairman of Global Vaccines, who was instrumental in establishing GSK’s investments in the field of bioelectronics, will chair the board of the new company. He said:

“Many of the processes of the human body are controlled by electrical signals firing between the nervous system and the body’s organs, which may become distorted in many chronic diseases. Bioelectronic medicine’s vision is to employ the latest advances in biology and technology to interpret this electrical conversation and to correct the irregular patterns found in disease states, using miniaturised devices attached to individual nerves. If successful, this approach offers the potential for a new therapeutic modality alongside traditional medicines and vaccines.

“This agreement with Verily to establish Galvani Bioelectronics signals a crucial step forward in GSK’s bioelectronics journey, bringing together health and tech to realise a shared vision of miniaturised, precision electrical therapies. Together, we can rapidly accelerate the pace of progress in this exciting field, to develop innovative medicines that truly speak the electrical language of the body.”

Brian Otis, Verily’s Chief Technology Officer, said: “This is an ambitious collaboration allowing GSK and Verily to combine forces and have a huge impact on an emerging field. Bioelectronic medicine is a new area of therapeutic exploration, and we know that success will require the confluence of deep disease biology expertise and new highly miniaturised technologies.

“This partnership provides an opportunity to further Verily’s mission by deploying our focused expertise in low power, miniaturised therapeutics and our data analytics engine to potentially address many disease areas with greater precision with the goal of improving outcomes.”

Galvani Bioelectronics will be headquartered within GSK’s global R&D centre at Stevenage in the UK, with a second research hub at Verily’s facilities in South San Francisco. It will initially employ around 30 expert scientists, engineers and clinicians, and will fund and integrate a broad range of collaborations with both parent companies, academia and other R&D companies. GSK and Verily believe this collaborative way of working will rapidly accelerate the development of bioelectronic medicines.

Kris Famm, GSK’s Vice President of Bioelectronics R&D, has been appointed President of the new company. Famm has pioneered work in both large and small molecule drug discovery and worked for a decade developing and delivering R&D strategy with a recurring focus on emerging technologies. He has co-designed and led GSK’s exploration of bioelectronics. A seven-member board, chaired by Moncef Slaoui, will also be appointed and will include Andrew Conrad, CEO of Verily. The new company will be fully consolidated in GSK’s financial statements.

This agreement is subject to customary closing conditions (including requisite antitrust approvals) and is expected to close before the end of 2016.

GSK and bioelectronics
Since 2012, a dedicated team of scientists at GSK has been researching the potential of bioelectronic medicines. In that time, the company has established a leadership position in the field, including creating a global network of around 50 research collaborations and investing $50m in a dedicated bioelectronics venture capital fund. Through these collaborations and investments, GSK has seen encouraging proof of principles in animal models in a range of diseases. It believes the first bioelectronic medicines could be ready for approval within the next decade.

For further information visit GSK’s bioelectronics media resource centre http://www.gsk.com/en-gb/media/resource-centre/bioelectronics/

The history of Galvani
Galvani Bioelectronics is named after Luigi Aloisio Galvani, an 18th century Italian scientist, physician and philosopher, who was one of the first to explore the field of bioelectricity. In 1780, he made the pivotal discovery that the muscles of a frog’s legs twitched when he touched the sciatic nerve with two pieces of metal, leading him to propose the theory of bioelectricity. Galvani’s discovery, while disputed by many of his peers, paved the way for the modern study of electrophysiology and neuroscience – two fields that are key to the development of bioelectronic medicines.

GSK – one of the world’s leading research-based pharmaceutical and healthcare companies – is committed to improving the quality of human life by enabling people to do more, feel better and live longer. For further information please visit www.gsk.com.

Health and Human Services Secretary Sylvia M. Burwell announced today $106.7 million in FY 2014 grant awards to 46 states, the District of Columbia, and five jurisdictions as part of the Maternal, Infant, and Early Childhood Home Visiting Program (Home Visiting Program) established by the Affordable Care Act. These funds will allow states to continue and expand voluntary, evidence-based home visiting services to women during pregnancy and to parents with young children up to age five.

“The Home Visiting Program helps to ensure that young families have the option to participate in a program that promotes their children’s healthy growth and development,” Secretary Burwell said. “Today’s announcement provides continued funding to support local home visiting programs as they work to improve the lives of children and families.”

The Home Visiting Program builds upon decades of scientific research, which shows that families that choose home visits by a nurse, social worker, or early childhood educator during pregnancy and in the first years of life benefit from important support services for healthy children and families. Home visit programs have been shown to prevent child abuse and neglect, and promote child health and development.

“These awards allow states to reach more parents and families in an effort to improve children’s health while at the same time building essential supports within their communities,” said Mary Wakefield, Ph.D., RN, administrator of the Health Resources and Services Administration (HRSA).

HRSA administers the Home Visiting Program in partnership with the Administration for Children and Families to provide states with the resources they need to expand home visiting programs and early childhood systems.

The Home Visiting Program serves as one part of a prenatal to age five continuum with the other parts of President Obama’s Early Learning Initiative: both high-quality infant and toddler care through Early Head Start-Child Care Partnerships and universal Pre-K to optimize the essential foundations in early childhood for future healthy development and well-being.