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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.

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.

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.

Beginning this week, consumers can visit HealthCare.gov to review detailed information about each health insurance plan offered in their area before applying ahead of open enrollment, which starts November 15, according to an announcement made today by Centers for Medicare & Medicaid Services (CMS) Administrator Marilyn Tavenner. With more issuers offering coverage through the Health Insurance Marketplace this year, the majority of consumers will find more affordable options for themselves and their families. By answering a few simple questions, such as location and family size, consumers will be able to compare plans and get an estimate on how much financial assistance they may qualify for when shopping for coverage, without needing to submit an application.

“Consumers can prepare for open enrollment by visiting HealthCare.gov and using the window shopping feature to see what plans will be available in their area,” said Administrator Tavenner. “Using this tool, consumers can compare plans, covered benefits, and physician and hospital networks before the Marketplace annual open enrollment period starts on November 15. New features will give consumers a comprehensive picture of the plans in their area so they can choose the one that’s right for them.”

CMS is working to improve the consumer experience by making the shopping experience easier. Last year, a consumer had to answer nine questions before being able to view their plan options, this year a consumer can start looking at plans after entering just their zip code. Consumers can answer a few simple questions relevant to them to get an estimate on how much financial assistance they may qualify for when shopping for coverage. The window shopping tool has also been optimized for access through a smart phone or tablet. Consumers can also review their options at a more convenient time by emailing or sharing a link to a plan’s information. Premium estimates are more accurate due to more robust data in HealthCare.gov, such as rates adjusted for tobacco use, which are being included in the estimates provided by the tool.

Window shopping remains the single most popular section on HealthCare.gov and regularly has three times the amount of traffic than any other page on the Marketplace website. CMS has improved the scalability and performance of the tool for high volumes of traffic. Additionally, the site has gone through usability and mobile testing that has been key in improving the website’s features.

Open Enrollment for the Health Insurance Marketplace begins Nov. 15, 2014, and runs through Feb. 15, 2015. Consumers should visit HealthCare.gov to review and compare health plan options and find out if they are eligible for financial assistance, which can help pay monthly premiums and reduce out-of-pocket costs when receiving services. All consumers shopping for health insurance coverage for 2015— even those who currently have coverage through the Marketplace — should enroll or re-enroll between November 15 and December 15 in order to have coverage effective on Jan. 1, 2015.

Consumers can find local help at: Localhelp.healthcare.gov or call the Federally-facilitated Marketplace Call Center at 1-800-318-2596. TTY users should call 1-855- 889-4325. Translation services are available. The call is free.

To preview plans in your area after the new feature is live, visit: https://www.healthcare.gov/see-plans/

For more information about Health Insurance Marketplaces, visit: www.healthcare.gov/marketplace

GENEVA – As part of WHO’s commitment to safety and protection of healthcare workers and patients from transmission of Ebola virus disease, WHO has conducted a formal review of personal protective equipment (PPE) guidelines for healthcare workers and is updating its guidelines in context of the current outbreak.

About the PPE guidelines
These updated guidelines aim to clarify and standardize safe and effective PPE options to protect health care workers and patients, as well as provide information for procurement of PPE stock in the current Ebola outbreak. The guidelines are based on a review of evidence of PPE use during care of suspected and confirmed Ebola virus disease patients.

The Guidelines Development Group convened by WHO included participation of a wide range of experts from developed and developing countries, and international organizations including the United States Centers for Disease Control and Prevention, Médecins Sans Frontières, the Infection Control Africa Network and others.

“These guidelines hold an important role in clarifying effective personal protective equipment options that protect the safety of healthcare workers and patients from Ebola virus disease transmission,” says Edward Kelley, WHO Director for Service Delivery and Safety. “Paramount to the guidelines’ effectiveness is the inclusion of mandatory training on the putting on, taking off and decontaminating of PPE, followed by mentoring for all users before engaging in any clinical care.”

Guidelines were developed from an accelerated development process that meets WHO’s standards for scientific rigour and serves as a complement to the Interim infection prevention and control guidance for care of patients with suspected or confirmed filovirus haemorrhagic fever in health-care settings, with focus on Ebola, published by WHO in August 2014.

Use of the personal protective equipment
Experts agreed that it was most important to have PPE that protects the mucosae – mouth, nose and eyes – from contaminated droplets and fluids. Given that hands are known to transmit pathogens to other parts of the body, as well as to other individuals, hand hygiene and gloves are essential, both to protect the health worker and to prevent transmission to others. Face cover, protective foot wear, gowns or coveralls, and head cover were also considered essential to prevent transmission to healthcare workers.

“Although PPE is the most visible control used to prevent transmission, it is effective only if applied together with other controls including facilities for barrier nursing and work organization, water and sanitation, hand hygiene, and waste management,” says Marie-Paule Kieny, Assistant Director-General of Health Systems and Innovation. Benefits derived from PPE depend not only on choice of PPE, but also adherence to protocol on use of the equipment.

A fundamental principle guiding the selection of different types of PPE was the effort to strike a balance between the best possible protection against infection while allowing health workers to provide the best possible care to patients with maximum ease, dexterity, comfort and minimal heat-associated stress.

In this situation where evidence is still being collected, to see what works best and on an effective sustainable basis, it was considered prudent to provide options for selecting PPE. In most cases, there was no evidence to show that any one of the options recommended is superior to other options available for healthcare worker safety.

Further work is needed to gather scientific experience and data from the field in systematic studies, in order to understand why some health workers are infected in the current outbreak and to increase effective clinical care. WHO is committed to working with international partners on these issues to build this evidence base.

Waltham, Mass. (October 28, 2014) — Optum and Alere today announced that Optum has entered into a definitive agreement to acquire Alere Health and its subsidiaries, which provide leading condition management, case management, wellbeing, wellness and women’s and children’s health services to more than 200 regional and local health plans, 89 Fortune 500 employers and 29 states. Alere Health’s services are offered to more than 22 million people across the U.S.

The $600 million cash transaction is subject to customary regulatory approval and other closing conditions. Such conditions for Alere include consent of the required lenders under Alere’s senior secured credit facility. The transaction does not require the approval of Alere’s shareholders.

Alere Health’s health management capabilities will broaden and strengthen the value Optum provides to health care payers, employers and states by improving the health of the people they serve and reducing overall health care costs. Adding Alere Health’s leading offerings in areas such as tobacco cessation and home-based obstetrical services to Optum’s broad scope of expertise and health services will enable delivery of more innovative and comprehensive population health management solutions for clients of both organizations.

“Alere Health’s expert team and proven health management solutions are a strong fit with our focus on empowering consumers to make more informed decisions, achieve healthier lifestyles and take greater ownership of their health,” said Larry Renfro, chief executive officer, Optum. “Adding Alere Health’s solutions and expertise allow us to be an even more valuable partner to payers, employers, federal and state governments and consumers in achieving their long-term population health and cost management goals.”

The sale of Alere Health is an important step in Alere’s execution of its strategy to focus on its core area of strength in rapid diagnostics and improve its balance sheet. Alere intends to use the proceeds from this transaction to reduce debt.

“Combining Alere Health and Optum allows our clients to continue to receive the leading health management solutions they need today and receive even greater value in the future. It allows Alere to focus on its strengths as the global leader in rapid diagnostics, where we have leading assets and operate in growing markets,” said Namal Nawana, president and CEO, Alere.

Covington Associates is serving as financial advisor and Foley Hoag LLP is serving as legal advisor to Alere.

About Optum
Optum is a leading information and technology-enabled health services business dedicated to helping make the health system work better for everyone. With approximately 80,000 people worldwide, Optum delivers intelligent, integrated solutions that help to modernize the health system and improve overall population health. Optum is part of UnitedHealth Group (NYSE:UNH). Please visit www.optum.com.

About Alere
Because Knowing now mattersTM, Alere delivers reliable and actionable information through rapid diagnostic tests, resulting in better clinical and economic healthcare outcomes globally. Headquartered in Waltham, Mass., Alere focuses on rapid diagnostics for infectious disease, cardiometabolic disease and toxicology. For more information on Alere, please visit www.alere.com.

This October, Pfizer Inc. is uniting with leaders in the breast cancer community in a public call-to-action to expand the breast cancer dialogue to include metastatic breast cancer. This comes after a first-of-its-kind survey commissioned by Pfizer revealed that many people know little to nothing about metastatic breast cancer – the most advanced stage of breast cancer (Stage IV), in which cancer has spread beyond the breast to other organs in the body.2,3

“With the public breast cancer conversation focused primarily on early detection and survivorship, metastatic patients often feel misunderstood and isolated from the larger breast cancer community,” said Shirley Mertz, president, Metastatic Breast Cancer Network (mbcn.org). “In fact, we need support and encouragement to face the significant mental demands of a disease for which we will always be in treatment. It will take commitment, attention and resources from multiple parties to change the environment, but the time is now to begin the next phase of the breast cancer movement, where all people living with breast cancer – the early, the advanced and the metastatic – feel equally embraced.”

Together with an external steering committee comprised of patient advocates, healthcare professionals and academic linguists, Pfizer has undertaken the Breast Cancer: A Story Half Told initiative to inspire change based on two complementary studies that have uncovered gaps in the breast cancer conversation within society at large and between patients and physicians in the doctor’s office.3,4

“Metastatic breast cancer is a diagnosis that can come with complicated treatment decisions,” said Freda Lewis-Hall, M.D., chief medical officer at Pfizer. “Furthermore, the emotional toll of metastatic disease can be profound, and can affect how people feel about themselves, communicate with others, and live their lives. Along with our partners, we believe that we can do more to educate about the current gaps in conversations about metastatic breast cancer and help empower those living with the disease to play a more active role in understanding their prognosis and their options for treatment.”

National Breast Cancer Survey Findings
In order to understand some of the external challenges facing metastatic breast cancer patients, a first-of-its-kind survey assessed breast cancer knowledge in 2,090 men and women in the U.S., aged 18 or older, who were representative of the U.S. population across various socioeconomic, geographic, educational and ethnic backgrounds.3

More than 60 percent of respondents said they know little to nothing about metastatic breast cancer. This lack of knowledge about metastatic disease was apparent in additional findings, which revealed the following facts were not well understood:

FACT: Early diagnosis does not guarantee survival – 72 percent of respondents thought that breast cancer in the advanced stages can be cured as long as it is diagnosed early.3 The reality is that even if diagnosed early, nearly 30 percent of women diagnosed with early breast cancer will progress to metastatic disease.5
FACT: Breast cancer progression can occur regardless of treatment or preventative measures taken – Half of people surveyed said they believe breast cancer progresses because patients either did not take the right treatment or the right preventative measures, signaling the potential stigmatization of people with metastatic disease.3 In reality, breast cancer can spread quickly and inexplicably, regardless of treatment or preventative measures taken.5
FACT: Prognosis of advanced disease remains poor and treatment options may be limited – Half of the survey respondents said they believe that a significant number of treatments are available for advanced breast cancer, and 41 percent said they believe that people with advanced breast cancer can live a long time.3 The reality is, while there have been advances in therapy, metastatic breast cancer currently remains incurable.2 The median survival following a metastatic breast cancer diagnosis is just three years.6

Conversations in the Doctor’s Office: Study Findings

This study was conducted to observe the interactions between metastatic breast cancer patients and their community-based oncologists in the physician’s office following a metastatic breast cancer diagnosis. In total, seven U.S. oncologists and 22 women with metastatic breast cancer participated.4

The study revealed significant gaps in patient and physician conversations and yielded three primary findings:

Patients discussing their prognosis and treatment options in the doctor’s office were not active participants in the conversation. This may suggest a need for tools or education that can lead to more detailed and productive conversations.4
When talking to patients still learning about their metastatic disease, oncologists often use vague or overly technical language, which may hinder meaningful discussion.4
The severity of metastatic disease tends to be minimized by physicians, and prognostic information was unclear to patients.4
Taken together, the results of the national survey and in-office study underscore the need to increase the understanding of metastatic disease within society at large, while empowering metastatic breast cancer patients to have a clear voice in conversations about their breast cancer experience in the doctor’s office and beyond. The full call-to-action, which includes specific recommendations from the steering committee on how this can be accomplished, and other information about Breast Cancer: A Story Half Told is available at www.pfizer.com.

About the “Breast Cancer: A Story Half Told” Steering Committee
The steering committee members, who were responsible for the development and contextualization of the above studies, include:

Joanne Buzaglo, Ph.D., Vice President, Research and Training, Cancer Support Community
Rich Frankel, Ph.D., Professor of Medicine, Senior Research Scientist, Indiana University School of Medicine
Heidi Hamilton, Ph.D., Professor and Chair, Department of Linguistics, Georgetown University
Hollye Jacobs, R.N., M.S., M.S.W., New York Times bestselling author of The Silver Lining: A Supportive & Insightful Guide to Breast Cancer and TheSilverPen.com, speaker and clinician
Arif Kamal, M.D., Director, Quality and Outcomes, Duke Cancer Institute
Shirley Mertz, J.D., President, Metastatic Breast Cancer Network
Lillie Shockney, R.N., Administrative Director, Johns Hopkins Breast Center

Pfizer Oncology and Metastatic Breast Cancer
In addition to researching and developing new treatments for metastatic breast cancer, Pfizer Oncology is committed to helping fulfill unmet educational and support needs for patients with metastatic breast cancer. We have embarked on a number of initiatives in partnership with leaders in the breast cancer community. In May 2014, Pfizer and the Avon Foundation for Women established the Avon-Pfizer Metastatic Breast Cancer Grants Program. This program is designed to support advocacy, academic and other not-for-profit organizations in providing information and services that help people with metastatic breast cancer navigate the medical and emotional challenges associated with their disease. Pfizer is also a founding member of the Metastatic Breast Cancer Alliance, which unifies the efforts of its members to help improve the lives of and outcomes for those living with metastatic breast cancer and their families through awareness and education, as well as advancing policy and strategic coordination of research funding specifically focused on metastatic disease.

For more information about the Avon-Pfizer Metastatic Breast Cancer Grants Program, please visit www.avonfoundation.org. For more information about the Metastatic Breast Cancer Alliance, please visit www.mbcalliance.org.

Pfizer Inc.: Working together for a healthier world®
At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products. Our global portfolio includes medicines and vaccines as well as many of the world’s best-known consumer health care products. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as one of the world’s premier innovative biopharmaceutical companies, we collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. For more than 150 years, Pfizer has worked to make a difference for all who rely on us. To learn more, please visit us at www.pfizer.com.

WOONSOCKET, R.I. and PROVIDENCE, R.I., — MinuteClinic, the retail medical clinic of CVS Health, and Lifespan, Rhode Island’s largest health system, which includes five partner hospitals and multiple physician groups, announced today that they have entered into a clinical collaboration agreement. The affiliation will enhance access to high quality, affordable health care services at MinuteClinic walk-in medical clinics opening inside select CVS/pharmacy stores in Rhode Island beginning later this week.

The new Rhode Island clinics, opening this fall and in 2015, will be located in Cranston, East Greenwich, North Smithfield,Providence, Wakefield, Westerly and Woonsocket.

The collaboration encourages interaction between Lifespan and MinuteClinic providers to improve coordination and access to care for patients seen at MinuteClinic locations. Toward that end, both organizations will integrate their electronic medical records to further promote exchange of clinical information, with patients’ permission.

For those patients who do not have regular access to primary care, MinuteClinic provides assistance in finding a primary care physician.

MinuteClinic locations in Rhode Island will be open seven days a week, offering weekday evening hours with no appointment necessary and most health insurance accepted. The clinics will be 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.

“As we have experienced in other states, including Massachusetts and Connecticut, MinuteClinic can support the primary care model in Rhode Island by helping to improve access to care, particularly on weekends and evenings when primary care providers may not be available,” said Andrew Sussman, M.D., president, MinuteClinic, and senior vice president/ associate chief medical officer, CVS Health. “Through our convenient locations, we’re pleased that the state’s largest health care system has agreed to affiliate with MinuteClinic to increase access and convenience for patients seeking care.”

Both MinuteClinic and Lifespan will eventually use the Epic electronic medical record to streamline communication around all aspects of each patient’s care. MinuteClinic will electronically share medical histories and visit summaries with the patient’s primary care provider at Lifespan. MinuteClinic will also send patient visit summaries to primary care providers who are not affiliated with Lifespan via fax or mail with the patient’s consent. MinuteClinic will also participate in Current Care, the state’s health information exchange.

Founded in 1994 by Rhode Island Hospital and The Miriam Hospital, Lifespan is a comprehensive, integrated, academic health system affiliated with The Warren Alpert Medical School of Brown University. Lifespan’s partners also include Rhode Island Hospital’s pediatric facility, Hasbro Children’s Hospital; Bradley Hospital and Newport Hospital. It includes a network of 1,842 affiliated physicians throughout the state.

“We’re pleased to collaborate with MinuteClinic to improve access and coordination of care for patients seen at clinic locations,” saidJohn Murphy, M.D., executive vice president, physician affairs, Lifespan. “We will continue to work with MinuteClinic and with our other physician partners to ensure the appropriate level of care is provided in a timely manner to all patients in our community.”

MinuteClinic nurse practitioners and physician assistants specialize in family health care and can diagnose, treat, and write prescriptions for common illnesses such as strep throat and ear, eye, sinus, bladder, and bronchial infections. Minor wounds, abrasions, skin conditions and joint sprains are treated, and common vaccinations such as influenza, tetanus, pneumonia, pertussis and hepatitis A and B are available at most locations. In addition, MinuteClinic administers a series of wellness services designed to help patients identify lifestyle changes needed to improve their current and future health, including screenings and monitoring for diabetes, high blood pressure, and high cholesterol.

MinuteClinic has clinical affiliations with more than 40 major health systems and health care providers across the country.

About Lifespan
Lifespan (www.lifespan.org) is a five-partner not-for-profit health care system based in Providence, R.I. Formed in 1994, Lifespan includes three teaching hospitals of The Warren Alpert Medical School of Brown University: Rhode Island Hospital and its Hasbro Children’s Hospital; The Miriam Hospital; and Bradley Hospital, the nation’s first psychiatric hospital for children. It also includes Newport Hospital, a community hospital offering a broad range of health services, and Gateway Healthcare, the state’s largest provider of community behavioral health care. Lifespan teaching hospitals are among the top recipients in the country of research funding from the National Institutes of Health. The hospitals received more than $83 million in external research funding in fiscal 2013. All Lifespan-affiliated partners are charitable organizations that depend on support from the community to provide programs and services.

About MinuteClinic
CVS/minuteclinic is the retail medical clinic of CVS Health (NYSE: CVS), the largest pharmacy health care provider in the United States. MinuteClinic launched the first retail medical clinics in the United States in 2000 and is the largest provider of retail clinics with more than 900 locations in 30 states and the District of Columbia. By creating a health care delivery model that responds to patient demand, MinuteClinic makes access to high-quality medical treatment easier for more Americans. Nationally, the company has provided care through more than 22 million patient visits, with a 95% customer satisfaction rating. MinuteClinic is the only retail health care provider to receive three consecutive accreditations from The Joint Commission, the national evaluation and certifying agency for nearly 20,000 health care organizations and programs in the United States. For more information, visitwww.MinuteClinic.com.

The Ebola virus was introduced into Nigeria on 20 July 2014 when an infected Liberian man arrived by aeroplane into Lagos, Africa’s most populous city. The man, who died in hospital 5 days later, set off a chain of transmission that infected a total of 19 people, of whom 7 died.

According to WHO recommendations, the end of an Ebola virus disease outbreak in a country can be declared once 42 days have passed and no new cases have been detected. The 42 days represents twice the maximum incubation period for Ebola (21 days). This 42-day period starts from the last day that any person in the country had contact with a confirmed or probable Ebola case.

Today, 20 October, Nigeria reached that 42-day mark and is now considered free of Ebola transmission.

WHO commends the Nigerian Government’s strong leadership and effective coordination of the response that included the rapid establishment of an Emergency Operations Centre.

When the first Ebola case was confirmed in July, health officials immediately repurposed technologies and infrastructures from WHO and other partners to help find cases and track potential chains of transmission of Ebola virus disease.

WHO, United States Centers for Disease Control and Prevention (CDC), Médecins Sans Frontières (MSF), UNICEF and other partners supported the Nigerian Government with expertise for outbreak investigation, risk assessment, contact tracing and clinical care.

Strong public awareness campaigns, teamed with early engagement of traditional, religious and community leaders, also played a key role in successful containment of this outbreak.

The Nigerian government and staff in the WHO country office are well aware that the country remains vulnerable to another imported case. The surveillance system remains at a level of high alert.

Nigeria has revised its national preparedness and response plan to ensure that the country is well prepared for other imported cases of the disease.

The development of a vaccine to prevent Ebola virus disease will be accelerated with support from the U.S. Department of Health and Human Services’ Office of the Assistant Secretary for Preparedness and Response (ASPR).

Under a one-year contract with Profectus BioSciences Inc., headquartered in Baltimore, ASPR’s Biomedical Advanced Research and Development Authority (BARDA) will provide approximately $5.8 million in funding, in addition to subject matter expertise and technical assistance, to further develop an experimental Ebola vaccine. The company will manufacture vaccine for use in animal safety studies and future clinical trials and conduct animal studies to test safety. The contract can be extended to a total of 13 months and $8.6 million.

Upon successful completion of this work, the company is expected to submit an investigational new drug application to the U.S. Food and Drug Administration (FDA). This application, once accepted by the FDA, would allow the vaccine to begin the first clinical trials for safety in humans.

“We are pushing hard to advance the development of multiple products as quickly as possible for clinical evaluation and future use in preventing or treating this deadly disease,” said BARDA Director Robin Robinson, Ph.D. “Our goal is to close the global gap in vaccines and therapeutics needed to protect the public health from Ebola as highlighted by the epidemic in West Africa.”

The project builds on early research of this experimental vaccine supported by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, and animal studies supported by the Department of Defense. In the DoD-supported studies, a single dose of the experimental Ebola vaccine provided 100 percent protection in non-human primates. BARDA will support further development of the vaccine against the Ebola virus strain responsible for the current epidemic.

Clinical trials are under way with other experimental vaccines. NIAID currently is supporting Phase 1 clinical trials that examine an investigational Ebola vaccine developed by GlaxoSmithKline and an experimental Ebola vaccine developed by the Public Health Agency of Canada and licensed to NewLink Genetics Corp. Phase 2 clinical efficacy trials for these vaccine candidates are expected in 2015.

BARDA also continues to explore how its Centers for Innovation in Advanced Development and Manufacturing, its Fill Finish Manufacturing Network, or other measures can accelerate the manufacturing time for Ebola therapeutics and vaccines.

The agency is seeking additional proposals for the advanced development of antibody treatments, antiviral drugs, and vaccines against the Ebola and Marburg viruses, both of which cause viral hemorrhagic fever. Program requirements are described in BARDA’s Broad Agency Announcement BARDA-BAA-13-100-SOL-00013 at https://www.fbo.gov.

HHS is the principal federal agency for protecting the health of all Americans and providing essential human services, especially for those who are least able to help themselves. The Office of the Assistant Secretary for Preparedness and Response (ASPR) leads HHS in preparing the nation to respond to and recover from adverse health effects of emergencies, supporting communities’ ability to withstand adversity, strengthening health and response systems, and enhancing national health security.

Within ASPR, BARDA develops and procures medical countermeasures – vaccines, medicines, diagnostics and medical equipment – that address the public health and medical consequences of chemical, biological, radiological, and nuclear (CBRN) accidents, incidents and attacks, pandemic influenza, and emerging infectious diseases.

DEERFIELD, Ill., – With Medicare’s Annual Election Period (AEP) set to begin Oct. 15, Walgreens (NYSE: WAG) (Nasdaq: WAG) today announced it has more than doubled its preferred network relationships with national Medicare Part D plan sponsors for 2015 and will be a part of preferred networks for nine plan sponsors. The networks are designed to offer greater access to pharmacy services and cost savings opportunities.

“The Medicare population is growing rapidly, and by working closely with plan sponsors as a part of preferred pharmacy networks, we’re uniquely positioned to help meet the prescription drug needs of America’s seniors and other Medicare beneficiaries,” said Kermit Crawford, Walgreens president of pharmacy, health and wellness. “With a higher prevalence of chronic disease in the U.S., along with the aging population, our pharmacists are playing an important role in health care, providing personalized care to help customers get, stay and live well.”

Newly Announced for 2015

Walgreens will have preferred network relationships with six new Medicare Part D plan sponsors and PBMs who support them for 2015, including Express Scripts, which features Walgreens as the only national pharmacy chain in two of its prescription drug plans.

Other new preferred network relationships for 2015 include:

Cigna-HealthSpring
EnvisionRx Plus
Prime Therapeutics LLC
Providence Health Plan
SilverScript
Renewed Preferred Networks

Walgreens will continue to be a part of preferred pharmacy networks with three national Medicare Part D plan sponsors:

Humana
UnitedHealthcare
WellCare
Walgreens is in the networks of hundreds of other Medicare prescription drug plans for 2015, in addition to participating in these preferred pharmacy networks. To help Medicare beneficiaries understand their prescription plan coverage options when Medicare open enrollment begins, Walgreens serves as one of the most convenient and accessible resources for Medicare Part D information, offering free, personalized plan comparison reports online and at every location, every day, to help beneficiaries evaluate the plans that may best meet their prescription drug needs. For more information, visit www.walgreens.com/medicare.

About Walgreens
As the nation’s largest drugstore chain with fiscal 2014 sales of $76 billion, Walgreens (www.walgreens.com) vision is to be America’s most loved pharmacy-led health, wellbeing and beauty enterprise. Each day, in communities across America, more than 8 million customers interact with Walgreens using the most convenient, multichannel access to consumer goods and services and trusted, cost-effective pharmacy, health and wellness services and advice. Walgreens scope of pharmacy services includes retail, specialty, infusion, medical facility and mail service, along with online and mobile services. These services improve health outcomes and lower costs for payers including employers, managed care organizations, health systems, pharmacy benefit managers and the public sector. The company operates 8,207 drugstores with a presence in all 50 states, the District of Columbia, Puerto Rico and the U.S. Virgin Islands. Walgreens digital business includes Walgreens.com, drugstore.com, Beauty.com, SkinStore.com and VisionDirect.com. Walgreens also manages more than 400 Healthcare Clinic and provider practice locations around the country.

BENTONVILLE, Ark. – Recent research says that more than 60 percent of people have reported difficulty understanding their health insurance plan options and nearly 40 percent feel they picked the wrong plan after enrollment.* To bring transparency and simplicity to the changing health insurance market, Walmart is working with DirectHealth.com to launch Healthcare Begins Here, an in-store program designed to educate customers on health insurance options. DirectHealth.com, an online health insurance comparison site which is an independent licensed health insurance agency, will provide a resource that brings Walmart customers unprecedented access to health insurance information and enrollment support.

DirectHealth.com also manages relationships with licensed insurance agents, enabling customers to compare coverage options and enroll in the plan that is right for them whether that be a Medicare plan or Public Healthcare Exchange plan through online, phone and in-store services.

“Walmart has long been known for innovation in health and wellness, and we’ll never stop delivering new products and services to the 140 million people who visit our stores each week,” said Labeed Diab, senior vice president and president, Health & Wellness, Walmart U.S. “For years, our customers have told us that there is too much complexity when it comes to understanding their health insurance options. Healthcare Begins Here addresses that complexity by bringing clarity and increased choice to the insurance enrollment process through DirectHealth.com.”

Since 2005, Walmart has hosted insurance agents from individual insurers in stores to answer questions and enroll customers in specific healthcare plans. Healthcare Begins Here, through DirectHealth.com, takes this offering to the next level in response to customers who wanted more options to choose from.

For customers over 65:
DirectHealth.com offers access to more than 1,700 plans from 12 leading carriers including Aetna, Cigna, Humana, UnitedHealthcare and participating Blue Cross and Blue Shield companies.**
Customers can compare and enroll in health plans online at DirectHealth.com or over the phone at 888-383-2111.
2,700 Walmart stores will be staffed by independent, licensed health insurance agents from DirectHealth.com that can help customers enroll in certain health insurance plans. Agents can also help provide education and guidance on other insurance options.
Enrollment can take place during the Medicare open enrollment period from Oct. 15, 2014 through Dec. 7, 2014.

For customers under 65:
DirectHealth.com offers access to thousands of Health Exchange plans from more than 300 leading carriers.
Customers can compare and enroll in health plans online at DirectHealth.com or over the phone at 888-327-0388.
2,700 Walmart stores will be staffed by independent, licensed agents from DirectHealth.com who can help provide education and guidance about health insurance options.
The Health Insurance Marketplace open enrollment period takes place from Nov. 15, 2014 to Feb. 15, 2015.

About Walmart
Wal-Mart Stores, Inc. (NYSE: WMT) helps people around the world save money and live better – anytime and anywhere — in retail stores, online, and through their mobile devices. Each week, more than 245 million customers and members visit our 11,000 stores under 71 banners in 27 countries and ecommerce websites in 10 countries. With fiscal year 2014 sales of over $473 billion, Walmart employs more than 2 million associates worldwide. Walmart continues to be a leader in sustainability, corporate philanthropy and employment opportunity. Additional information about Walmart can be found by visiting http://corporate.walmart.com on Facebook at http://facebook.com/walmart and on Twitter at http://twitter.com/walmart. Online merchandise sales are available at http://www.walmart.com and http://www.samsclub.com.

About DirectHealth.com
DirectHealth.com is an insurance agency, contracted with TZ Insurance Solutions LLC.

About TZ Insurance Solutions, LLC
TZ Insurance is a wholly owned subsidiary of TRANZACT, a large company providing direct-to-consumer services in the insurance sector. Based in Fort Lee, NJ, TZ Insurance has 1,000 employees, of which more than 700 are licensed insurance agents across life, health and property and casualty insurances.

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.

“The world can and must stop Ebola – now,” Secretary-General Ban Ki-moon told world leaders gathered at a special meeting held today at the United Nations to speed up the global response to the outbreak that has evolved from a public health crisis into a threat to peace and security.

“We come together today in solidarity with the people of Guinea, Liberia and Sierra Leone as they face the largest and most deadly Ebola outbreak the world has ever seen,” Mr. Ban said at the High-level Event on Ebola Virus Disease Outbreak.

The Director-General of the World Health Organization (WHO), Margaret Chan, said: “Every day, every minute, counts. We need to talk but we also need to act with speed and efficiency and in ways that deal this virus some heavy blows.”

The Secretary-General said “there is overwhelming international political momentum for the United Nations to play a leading role in coordinating the global response,” and that within 24 hours of a call for staff to deploy in the first UN mission for a public health emergency, the UN had received 4,000 applications.

More than two dozen world leaders participated in the meeting, held on the margins of the General Assembly’s annual high-level debate, including Guinean President Alpha Condé, while others like Presidents Ellen Johnson-Sirleaf of Liberia and Ernest Bai Koroma of Sierra Leone joined by teleconference.

Some of the participants at the high-level meeting on the Response to the Ebola Virus Disease Outbreak. UN Photo/Rick Bajornas
‹›
All speakers flagged the need for a greater sense of urgency to respond to the outbreak, which WHO has described as “the most severe acute public health emergency seen in modern times.”

“This is a fight for all of us,” President Koroma said by video-link from the capital, Freetown.

United States President Barack Obama, whose country has offered military leadership and the establishment of a regional command and control centre in Monrovia, encouraged a faster and sustained response, saying: “It’s a marathon but we have to run it as a sprint. That’s why we all have to chip in.” He said on Friday, the White House will host 44 nations in a global health security summit.

Some, like World Bank President Jim Yong Kim, warned of the consequences of not rising to the challenge of tackling the outbreak in Africa, which the UN Security Council has declared a threat to peace and security.

“We are talking about nothing less than a potential meltdown of this continent,” said Mr. Kim, who announced that the World Bank would commit $400 million to the Ebola response in West Africa.

The German Foreign Minister, Frank-Walter Steinmeier, announced some 2,000 volunteers to combat Ebola, and Japanese Prime Minister Shinzo Abe said his country is working on an Ebola vaccine. UN Deputy Secretary-General Jan Eliasson commended Cuba for its swift dispatch of doctors in response to the outbreak in West Africa.

After the formal meeting, British actor Idris Elba – whose family is from Sierra Leone – spoke of his commitment to galvanize support for the response and commended health workers who are daily risking their lives on the ground, but said “We need more, we need more people.”

To date, Ebola has sickened 6,263 and killed 2,917 as of 21 September, according to official statistics reported to WHO by health ministries in Guinea, Liberia, Nigeria, Senegal and Sierra Leone with health experts predicting that the number will rise exponentially unless the virus is contained and controlled.

Mr. Ban convened today’s meeting to speed up the global response to contain and stop the spread of the virus, treat those who are infected, ensure essential services, preserve stability and prevent outbreaks in other countries.

The meeting follows the Secretary-General’s establishment last week of the UN Mission for Ebola Emergency Response, or UNMEER, to support prevention efforts throughout the region.

In today’s speech, Mr. Ban said the Ebola crisis has highlighted the need to strengthen early identification systems and early action.

“We should consider whether the world needs a standby corps of medical professionals, backed by the expertise of WHO and the logistical capacity of the United Nations,” he said. “Just as our troops in blue helmets help keep people safe, a corps in white coats could help keep people healthy.”

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.

ST. PAUL, Minn.– More than 25 million Americans, including many children, suffer from asthma and allergies, causing them to miss work or school and costing millions of dollars in healthcare expenses1. To help reduce exposure to allergy and asthma triggers, many patients implement lifestyle changes, such as washing bedding frequently, using hypo-allergenic pillow cases and HEPA vacuum cleaners, and using high-efficiency air filters in forced heating and cooling systems. While some may question the effectiveness of these changes, a new study published in the August issue of the Journal of Asthma found that using a high-efficiency air filter with a MERV rating of 12 or higher can effectively reduce indoor levels of common airborne asthma and allergy triggers.

The study2 was designed and conducted by Environmental Health & Engineering, Inc., (EH&E) of Needham, Mass. EH&E professionals evaluated the effectiveness of six types of residential air filters at capturing four types of microscopic particles found in indoor air of homes – cat allergen, respiratory virus, and indoor and outdoor fine particulates – all of which can affect indoor air quality and contribute to cough, shortness of breath, wheezing, and other asthma symptoms.

“While other studies have addressed ways to manage asthma at home, this is one of the first to evaluate the use of high-efficiency filters as an important part of the solution,” said Dr. David L. MacIntosh, Chief Science Officer with EH&E and Adjunct Associate Professor at the Harvard School of Public Health. “Some asthma interventions can be quite costly, yet this study demonstrates that spending an extra $50 per year for a higher-efficiency filter may have significant impacts on levels of many airborne triggers in the home.”

While effective asthma interventions should include several elements, study results show that the Filtrete Healthy Living Ultra Allergen Reduction and Filtrete Healthy Living Ultimate Allergen Reduction 1-inch air filters captured more than 50 percent of asthma and allergy triggers in a typical home. These filters also were found to be more than nine times as effective as standard fiberglass filters.

About 3M
3M captures the spark of new ideas and transforms them into thousands of ingenious products. Our culture of creative collaboration inspires a never-ending stream of powerful technologies that make life better. 3M is the innovation company that never stops inventing. With $31 billion in sales, 3M employs 89,000 people worldwide and has operations in more than 70 countries. For more information, visit www.3M.com or follow @3MNews on Twitter.

Chalfont St Giles, — As the European Congress of Pathology begins this weekend in London, new research from GE Healthcare shows that many people do not understand the importance of the pathologist in the diagnosis and treatment of breast cancer1, the most common cancer in Europe, with more than 464,000 new cases diagnosed in 2012.2

Pathologists are vital to the diagnosis and clinical management of disease and are involved in 100% of all cancer diagnoses and in most patient care pathways. Of the 39% of people in the UK who did know pathologists play a role in diagnosing the disease, only just over half knew that pathologists also play a part in the ongoing treatment of a patient.

GE Healthcare’s Sara Dalmasso who leads their Digital Pathology business in Europe said: “We know the role of the pathologist is not well understood and these results support that. This lack of understanding may be one reason why there has been little investment so far in empowering pathologists who examine tissue samples with new tools and ways of working.

“Today, tissue slides have to be physically taken to the pathologist, or the pathologist has to travel to view them under a traditional microscope. This can result in delays, risks slides being lost or damaged and makes collaboration difficult. We’re working with pathologists to help improve the speed and accuracy of diagnosis using our Omnyx digital pathology solution. And investing in technology is clearly good news for patients – quicker diagnosis, less time anxiously waiting for results and easy access to the opinion of specialists.”

Dr Suzy Lishman, Vice President and President Elect at the Royal College of Pathologists, said: “We are not surprised by these findings. We know many people understand little about the role the pathologist plays in their diagnosis and treatment. The Royal College of Pathologists runs programmes to raise awareness of the speciality including National Pathology Week, which will be held in November this year, so that patients can understand who is involved in their care and treatment.

“The College also recognises the benefits that investing in technology like digital pathology can have for patient care. Examples include pathologists being able to seek a swift second opinion from colleagues based anywhere in the world as well helping in the provision of out of hours services and opportunities for use in training. However, it remains essential that digital pathology services are standardised, are subject to quality controls and clinical audit, to ensure they help deliver the best care for patients.”

The GE research results showed that less than 50% of people surveyed in the US understood the pathologist role in diagnosing breast cancer compared to 78% of respondents in Russia and less than 20% of respondents in Japan and Korea1.

This news is courtesy of www.ge.com

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.

oche (SIX: RO, ROG; OTCQX: RHHBY) and InterMune, Inc. (NASDAQ: ITMN) today announced they have entered into a definitive merger agreement for Roche to fully acquire InterMune at a price of US$ 74.00 per share in an all-cash transaction. This corresponds to a total transaction value of US$ 8.3 billion on a fully diluted basis. This offer represents a premium of 38% to InterMune’s closing price on 22 August 2014 and a premium of 63% to InterMune’s unaffected closing price on 12 August 2014. The merger agreement has been approved by the boards of InterMune and Roche.

Under the terms of the merger agreement, Roche will commence a tender offer no later than 29 August 2014, to acquire all outstanding shares of InterMune common stock, and InterMune will file a recommendation statement containing the unanimous recommendation of the InterMune board that InterMune’s shareholders tender their shares to Roche. The transaction is expected to be neutral to core earnings per share in 2015 and accretive from 2016 onwards.

The acquisition of InterMune, a Brisbane, California based biotechnology company focused on the research, development and commercialization of innovative therapies in pulmonology and fibrotic diseases, will allow Roche to broaden and strengthen its respiratory portfolio globally. InterMune’s lead medicine pirfenidone is approved for idiopathic pulmonary fibrosis (IPF) in the EU and Canada and under regulatory review in the United States. IPF is a progressive, irreversible and ultimately fatal disease characterized by progressive loss of lung function due to fibrosis, or scarring, in the lungs. Roche markets Pulmozyme and Xolair in the US and has other novel therapeutic medicines targeting respiratory diseases in clinical development.

Commenting on the transaction, Severin Schwan, CEO of Roche, said, “We are very pleased that we reached this agreement with InterMune. Our offer provides significant value to InterMune’s shareholders and this acquisition will complement Roche’s strengths in pulmonary therapy. We look forward to welcoming InterMune employees into the Roche Group and to making a difference for patients with idiopathic pulmonary fibrosis, a devastating disease.”

Roche plans a smooth transition of InterMune employees and operations into the Roche organisation, ensuring readiness for an expected launch of pirfenidone in the US in 2014. Commenting on the transaction, InterMune’s Chairman, CEO and President, Dan Welch, said, “This merger recognizes the significant value created by our team’s commitment, hard work and execution for more than a decade to develop and commercialize treatment options for IPF patients and their families. Roche shares our passion and commitment to the IPF community and to ensuring that pirfenidone is available as quickly as possible to patients in the United States, pending FDA approval. Roche’s global resources and scale will not only facilitate and accelerate our ability to deliver pirfenidone to more patients around the world, but also to realize our joint vision to bring additional innovative therapies to patients with respiratory diseases.”

Pirfenidone has been marketed by InterMune in the EU and Canada as Esbriet® since regulatory approval in 2011 and 2012 respectively. After previous regulatory review in the USA in 2010, the Food and Drug Administration (FDA) recommended an additional Phase 3 clinical trial to support the efficacy of pirfenidone. The results of this study, the ASCEND trial, were part of the new drug application (NDA) resubmission that InterMune made in May 2014. On 17 July 2014 pirfenidone received breakthrough therapy designation from the FDA. This designation is reserved for drugs that are intended to treat a serious or life-threatening disease or condition and preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints. The target action date, also known as the PDUFA date, for the pirfenidone NDA is 23 November 2014.

In addition to pirfenidone, InterMune has research programmes exploring new targets and pathways that may ultimately lead to improved treatment options for people with IPF, and other fibrotic diseases.

Terms of the agreement
Under the terms of the merger agreement, Roche will promptly commence a tender offer to acquire all of the outstanding shares of InterMune’s common stock at a price of US$74.00 per share in cash. The closing of the tender offer will be subject to the tender of a number of shares that represents a majority of the total number of outstanding shares on a fully diluted basis. In addition, the transaction is subject to the expiration or termination of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976 and other customary conditions.

Following completion of the tender offer, Roche will acquire all remaining shares at the same price of US$74.00 per share through a second step merger. The closing of the transaction is expected to take place in 2014.

Citi is acting as financial advisor to Roche and Davis Polk & Wardwell LLP is acting as legal counsel to Roche. Centerview Partners and Goldman Sachs are acting as financial advisors to InterMune and Cravath, Swaine & Moore LLP is acting as legal counsel to InterMune.

About Idiopathic Pulmonary Fibrosis (IPF)
Idiopathic pulmonary fibrosis (IPF) is a progressive, irreversible and ultimately fatal disease characterized by progressive loss of lung function due to fibrosis (scarring) in the lungs, which hinders the ability of lungs to absorb oxygen. IPF inevitably causes shortness of breath, and a deterioration in lung function and exercise tolerance. IPF patients follow different and unpredictable clinical courses and it is not possible to predict if a patient will progress slowly or rapidly, or when the rate of decline may change. Periods of transient clinical stability in IPF, when they occur, inevitably give way to continued disease progression. The median survival time from diagnosis is two to three years which makes IPF more rapidly lethal than many malignancies, including breast, ovarian and colorectal cancers. IPF typically occurs in patients over the age of 45, and tends to affect slightly more men than women.

About Pirfenidone
Pirfenidone is an orally active, anti-fibrotic agent that inhibits the synthesis of TGF-beta, a chemical mediator that controls many cell functions including proliferation and differentiation, and plays a key role in fibrosis. Pirfenidone also inhibits the synthesis of TNF-alpha, a cytokine that is known to have an active role in inflammation.

On 28 February 2011, the European Commission granted marketing authorization for Esbriet® (pirfenidone) for the treatment of adults with mild to moderate IPF. The approval authorized marketing of Esbriet in all 28 EU member states. Esbriet has since been approved for marketing in Norway and Iceland. In 2011, InterMune launched commercial sales of pirfenidone in Germany under the trade name Esbriet, and Esbriet is now also commercially available in various European countries, including key markets such as France, Italy and the UK.
On 1 October 2012, Health Canada approved Esbriet for the treatment of mild to moderate IPF in adult patients. Health Canada designated Esbriet for Priority Review and completed the accelerated review according to target guidelines of 180 days. InterMune launched Esbriet in Canada in January 2013.

Pirfenidone has been marketed as Pirespa® since 2008 in Japan and since 2012 in South Korea by Shionogi & Co. Ltd. Under different trade names, pirfenidone is also approved for the treatment of IPF in China, India, Argentina and Mexico.

Pirfenidone is currently under regulatory review in the United States with the FDA.

About InterMune
InterMune is a biotechnology company focused on the research, development and commercialization of innovative therapies in pulmonology and orphan fibrotic diseases. In pulmonology, the company is focused on therapies for the treatment of idiopathic pulmonary fibrosis (IPF), a progressive, irreversible, unpredictable and ultimately fatal lung disease. InterMune’s research programs are focused on the discovery of targeted, small-molecule therapeutics and biomarkers to treat and monitor serious pulmonary and fibrotic diseases. For additional information about InterMune and its R&D pipeline, please visit http://www.intermune.com

About Roche
Headquartered in Basel, Switzerland, Roche is a leader in research-focused healthcare with combined strengths in pharmaceuticals and diagnostics. Roche is the world’s largest biotech company, with truly differentiated medicines in oncology, immunology, infectious diseases, ophthalmology and neuroscience. Roche is also the world leader in in vitro diagnostics and tissue-based cancer diagnostics, and a frontrunner in diabetes management. Roche’s personalised healthcare strategy aims at providing medicines and diagnostics that enable tangible improvements in the health, quality of life and survival of patients. Founded in 1896, Roche has been making important contributions to global health for more than a century. Twenty-four medicines developed by Roche are included in the World Health Organisation Model Lists of Essential Medicines, among them life-saving antibiotics, antimalarials and chemotherapy.

In 2013 the Roche Group employed over 85,000 people worldwide, invested 8.7 billion Swiss francs in R&D and posted sales of 46.8 billion Swiss francs. Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan. For more information, please visit www.roche.com.

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