Keyword: Food and Drug Administration (FDA)

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Jury Orders J&J Unit to Pay $8.3 Million in Metal Hip Trial

09.03.2013 - A Los Angeles jury ordered Johnson & Johnson's DePuy orthopedic unit to pay more than $8 million in damages in the first trial of nearly 11,000 lawsuits filed over the company's...

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Pfizer Gets Celebrex Patent Extension

05.03.2013 - U.S. regulators granted Pfizer a reissued patent on its multibillion-dollar Celebrex pain drug that extends its marketing exclusivity until early December 2015, the company said on...

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Switzerland's Roche Pledges to Open Up Access to Drug Data

26.02.2013 - Swiss drugmaker Roche Holding has agreed to expand access to its clinical trial data as the pharmaceutical industry faces calls for greater transparency on scientific data. The...

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FDA Halts Trials of Amgen Drug in Children, Cites Death

26.02.2013 - The U.S. Food and Drug Administration said on Tuesday it has stopped all pediatric clinical trials of Amgen's Sensipar after the death of a 14-year-old patient taking part in a...

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Affymax, Takeda Recall Anemia Drug Omontys After Deaths

25.02.2013 - U.S.-based Affymax and Japan's Takeda Pharmaceutical said they are voluntarily recalling all lots of anemia treatment Omontys (peginesatide) in the United States due to reports of...

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GSK Vaccine Ingredient Scrutinized for Narcolepsy Clues

08.02.2013 - Mounting evidence of a link between GlaxoSmithKline's Pandemrix flu shot and a spike in narcolepsy cases among children in Europe is putting one of the vaccine's key ingredients...

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Boehringer Ingelheim Ohio Subsidiary Enters Consent Decree

01.02.2013 - Ben Venue Laboratories, a unit of German drug company Boehringer Ingelheim, may not freely make or distribute drugs from its facility in Bedford, Ohio, until U.S. regulators have...

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FDA Head, Company CEOs Cheer Bumper Haul of New Drugs

26.01.2013 - Pharmaceutical industry productivity is improving as a more targeted approach to drug development yields dividends and regulators offer speedier decisions on medicines that make a...