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U.S. files criminal charges against sellers of Jack3d, other supplements

USPlabs, which sold the best-selling workout supplement Jack3d, and six of its executives face criminal charges for the unlawful sale of nutritional supplements, the U.S. Justice Department said Tuesday in announcing a larger probe by federal agencies aimed at stemming the sale of unproven products. The indictment says that USPlabs LLC used a synthetic stimulant […]

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U.S. doctor group calls for ban on drug advertising to consumers

The American Medical Association on Tuesday called for a ban on advertising prescription drugs and medical devices directly to consumers, saying the ads drive patients to demand expensive treatments over less costly ones that are also effective. The influential doctors’ group said the new policy reflects physicians’ concerns that marketing spending on a proliferation of […]

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Obama nominee to lead FDA defends drug industry ties

President Barack Obama’s nominee to head the U.S. Food and Drug Administration defended his ties to the pharmaceutical industry on Tuesday during a Senate committee hearing that included questions on soaring drug prices. Presidential candidate Bernie Sanders was among the Democrats who grilled Dr. Robert Califf, 64, who joined the FDA in January as a […]

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Depomed Acquires U.S. Rights to Late-Stage, First-in-Class Pain Product from Grunenthal

NEWARK, Calif., Nov. 17, 2015 /PRNewswire/ — Depomed, Inc. (NASDAQ: DEPO) today announced that it has entered into a definitive agreement to acquire the U.S. and Canadian rights to cebranopadol and its related follow-on compound from Grünenthal GmbH (“Grünenthal”). Cebranopadol is a novel, first-in-class analgesic in development for the treatment of moderate to severe chronic nociceptive […]

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GA Communication Group Expands Account Leadership Team With Hiring of Chris Weber as SVP, Group Account Director

Chicago, Nov.17, 2015 — GA Communication Group, one of the nation’s leading independent, full-service healthcare communications agencies, has hired veteran marketer Chris Weber as senior vice president, group account director. With 24 years of healthcare agency experience on both the creative and account sides of the business, Weber will help lead GA through a period […]

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AstraZeneca’s Tagrisso to cost $12,750 for a month’s supply

AstraZeneca’s new lung cancer pill Tagrisso, which won early U.S. approval on Friday, will cost $12,750 for a month’s supply.   A company spokeswoman said on Tuesday the wholesale acquisition cost was comparable to other targeted oral lung cancer therapies, such as Pfizer’s Xalkori and Novartis’ Zykadia. AstraZeneca has previously said it believes Tagrisso could generate […]

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Pfizer-Allergan Deal is Contingent Upon Saunders Becoming CEO

November 17, 2015By Mark Terry, BioSpace.com Breaking News Staff   With a Pfizer Inc. (PFE)-Allergan Inc. (AGN) deal facing a self-imposed announcement deadline for next week, inside sources indicate the deal is dependent upon Allergan’s Brent Saunders becoming chief executive officer of the newly merged company. Of particular interest—and concern—is how Saunders, who has not […]

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How Vertex’s Long-Term $500K Gamble Paid Off with a $30 Billion Return

November 17, 2015By Mark Terry, BioSpace.com Breaking News Staff   Boston-based Vertex Pharmaceuticals (VRTX) presents an unusual business model one that has been the focus of a Harvard case study. In short, in 2001 the company took a relatively small grant from the Cystic Fibrosis Foundation and spun it into a highly successful development program. […]

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U.S. firefighter gets world’s most extensive face transplant

A volunteer firefighter from Mississippi whose face was burned off during a home fire rescue received the world’s most extensive face transplant, New York University Langone Medical Center said on Monday. After a 26-hour surgery performed at the New York hospital in August, 41-year-old Patrick Hardison is living with the face of 26-year-old David Rodebaugh, […]

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Roche breast cancer drug at center of UK pricing row

A Roche drug that can prolong the lives of some women with advanced breast cancer has been plunged back into the center of a drug pricing row after Britain’s health cost agency declared that it is still too expensive. The stand-off shows how the price of medicines is as pressing and emotive an issue in […]

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Alcoholism drug can wake up dormant HIV to be killed, study finds

Scientists seeking a cure for the AIDS virus have made an unexpected discovery with a drug designed to combat alcoholism which they say could be a critical part of a strategy to “wake up” and then kill dormant HIV hiding in the body. The drug, branded as Antabuse but also sold as a generic called […]

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Moderate coffee drinking may be tied to lower risk of death

(Reuters Health) – People who drink coffee daily, even up to four cups per day, are less likely to die from heart disease, neurological disease, type 2 diabetes or suicide than others, according to a new study. Researchers did not test how upping coffee consumption would change health outlooks, so they cannot conclude that coffee […]

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DARZALEX (daratumumab) Approved by U.S. FDA: First Human Anti-CD38 Monoclonal Antibody Available for the Treatment of Multiple Myeloma

    First-in-class immunotherapy approved for multiple myeloma patients who have received three or more prior lines of therapy, including a proteasome inhibitor (PI) and an immunomodulatory agent or who are double refractory to a PI and an immunomodulatory agent PR Newswire, HORSHAM, PA, November 16, 2015 Janssen Biotech, Inc., a Janssen Pharmaceutical Company of […]

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FDA approves J&J drug for advanced multiple myeloma

U.S. regulators have approved an experimental treatment from Johnson & Johnson that may offer hope to multiple myeloma patients who have run out of other options against the blood cancer. The U.S. Food and Drug Administration on Monday said it had approved Darzalex (daratumumab) for patients who had already undergone at least three prior standard […]

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Jennifer Durante Named EVP, Director of Client Services, Digitas Health LifeBrands

Durante Brings Consumer Relations Experience to Health and Wellness Space  NOVEMBER 16 2015, NEW YORK CITY – Consumer relationship leader and industry veteran Jennifer Durante has joined the New York account team of Digitas Health LifeBrands as its new EVP, Director of Client Services, charged with nurturing and growing the New York account team and […]

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Misunderstanding of antibiotics fuels superbug threat, WHO says

People across the world are alarmingly confused about the role of antibiotics and the right way to take them, and this ignorance is fuelling the rise of drug-resistant superbugs, the World Health Organization said on Monday. “The rise of antibiotic resistance is a global health crisis,” WHO Director-General Margaret Chan told reporters in a telebriefing […]

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Clovis slumps after FDA asks for more data on lung cancer drug

Clovis Oncology Inc said the U.S. Food and Drug Administration asked for additional clinical data on the effectiveness of its experimental lung cancer drug, rociletinib, which could delay its approval. Clovis’s shares slumped 69 percent in premarket trading on Monday. The company had a market value of $3.8 billion as of Friday’s close. Clovis said […]

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Array BioPharma And Pierre Fabre Announce Development And Commercialization Collaboration For Two Novel Oncology Products, Binimetinib And Encorafenib

– Array to receive a $30 million up-front payment and up to $425 million in additional development and commercialization milestones, as well as robust double-digit royalties on future sales – – Array retains full commercialization rights to binimetinib and encorafenib in United States, Canada, Japan and Korea – -NEMO Phase 3 trial remains on-track for […]

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Late Stage Study Shows Merck & Co.’s Hepatitis C Drug Cures Addicts

Merck Announces Presentation of Phase 3 Results of Investigational Elbasvir/Grazoprevir in People with Chronic Hepatitis C Genotypes 1, 4 or 6 Infection Who Inject Drugs and Are on Opioid Agonist Therapy – Results from C-EDGE CO-STAR Presented at The Liver Meeting® Show High Sustained Virologic Response After 12 Weeks of Treatment KENILWORTH, N.J.–(BUSINESS WIRE)–   […]

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Genfit could bring NASH liver disease treatment to market in 2019

French biopharmaceutical company Genfit said on Monday it is to launch a phase 3 study of its treatment for liver disease NASH by year-end as part of an accelerated approval procedure which could allow it to be brought to market in 2019. Genfit shares rose 5 pct to 42.71 euros on the news. There is […]

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