Biotech company Celgene Corp. on Wednesday sent a letter to doctors warning that a study of its drug to treat dangerous blood clots suggests it may increase the risk of death in elderly patients.
The letter, posted late Wednesday on the Web site of the Food and Drug Administration, recommends that doctors consider alternatives to Innohep [...]

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Even after a drug’s been on the market for years and taken by millions of people, regulators often have to rely on data from clinical trials — which involve only a few thousand people — to gauge whether a drug presents serious safety risks. That can be a big problem for hazards that are relatively [...]

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The FDA approved more new drugs in 2008 than in any of the previous three years, The Wall Street Journal reported. The agency approved 24 “first-of-a-kind” drugs last year, compared with 18 in 2007, 22 in 2006 and 20 in 2005, in addition to authorising dozens of other applications for new formulations or new uses [...]

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The FDA is going to get some expert help as it decides whether to finally approve prasugrel, Eli Lilly’s powerful anti-clotting drug and would-be competitor to blockbuster Plavix.
Lilly and partner Daiichi Sankyo said this morning that the FDA’s Cardiovascular and Renal Drugs Advisory Committee would meet Feb. 3. The companies didn’t offer any details about [...]

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With some data showing that the anti-clotting medicine Plavix may not work well in almost a third of patients with a genetic variant, the FDA may look for changes to the instructions for the drug.
The WSJ reports on talks between the agency and Bristol-Myers Squibb over a revision to the label for Plavix, the second-biggest [...]

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AstraZeneca is considering the development of biosimilars to expand its existing operations in biological drugs.

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A challenge launched by the generic drug makers seeking shorter patent regulations will be heard Tuesday in Federal Court.

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Biogen Idec and Elan reported Monday that they notified regulators of the fourth case this year of progressive multifocal leukoencephalopathy (PML) in a patient taking their multiple sclerosis drug Tysabri.

The companies said that the latest case of PML was observed in a patient in Germany who had received Tysabri as monotherapy for 26 months. Biogen [...]

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There are efforts to get drugmakers to disclose more trial results, such as a rule requiring them to register trials and provide results on clinicaltrials.gov.

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The European Commission adopted a series of reforms for the pharmaceutical industry partly aimed at curbing the incidence of drug counterfeiting. The proposals, which require backing from EU member states and the European Parliament, would also allow drugmakers to promote information about prescription products directly to consumers for the first time.

Under the proposed changes, medications [...]

Popularity: 11% [?]