antidepressant news from FierceBiotech

Wyeth announced late Friday that it won FDA approval for Pristiq, its next-generation version of the antidepressant Effexor. Wyeth was looking for an approval of Pristiq to offset the Read more...

Yesterday we reported on an article published in the New England Journal of Medicine that found studies with Read more...

The market for insomnia drugs in the U.S. is growing at a whopping 29 percent per year, hitting $4.6 billion in 2006 and attracting the attention of a wide range of drug developers. More than a Read more...

Sanofi-Aventis had some good news and some bad news to deliver to analysts during its first pipeline update in two years. On the down side: Its Alzheimer's drug Xaliproden failed late-stage trials. Read more...

Shares of Clinical Data got a modest boost on the news that its late-stage study of the antidepressant Vilazodone produced positive results. A companion pharmacogenetic test may make it easier to Read more...

> Bavarian Nordic and GlaxoSmithKline have dropped their agreement to jointly market Imvamune, a smallpox vaccine now in development. When the deal was signed in 2004 Bavarian Nordic didn't have the production capacity needed but says it can commercialize the therapy now on its own. Report

> Responding to rumors of pipeline trouble, …

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The BBC says it will air a program tonight that claims GlaxoSmithKline distorted trial data in an attempt to gain regulators' approval to use the antidepressant Seroxat as a therapy for children. The report claims that Glaxo covered up the drug's link to teen suicide and hid the fact that the drug had failed clinical trials. Glaxo, though, flatly rejected the report's conclusion, saying it never hid any data and brought the …

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The FDA has issued an approvable letter to Wyeth for its antidepressant Pristiq. "The approvable letter is in line with Wyeth's expectations and we remain on track with our plans for Pristiq," says Joseph Mahady, President, Wyeth Pharmaceuticals, the Americas and Global Businesses. "We are working toward resolution of all outstanding issues at our manufacturing site in Guayama, Puerto Rico and have already made significant progress in meeting previously established commitments."

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Wyeth is signaling that the FDA is likely to extend tentative approval for Pristiq, an antidepressant, but that the agency is likely to ask for more data. The drug is a derivative of Effexor, a blockbuster that will lose patent protection in 2010. Ultimately, though, analysts believe that Pristiq's biggest potential may be for treating menopause. Antidepressants have proven effective in treating the symptoms of hot flashes without posing the risks now linked to hormone replacement …

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Biovail has lost a last-ditch attempt to prevent copycat versions of its popular antidepressant Wellbutrin from hitting the market. A federal judge has ruled against a move to gain a temporary restraining order and an injunction against the FDA to prevent it from approving a generic. The ruling clears the path for Anchen to start selling a competing generic.

- here's the AP report on the ruling