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Glutamate a big target for drug developers

The New York Times' Alex Berenson looks at the wave of new research programs focused on the neurotransmitter Read more...

Blogster sees lessons in FDA approvable letters

The blogster Eye on FDA has tracked down and posted every Read more...

Northstar brain therapy fails late-stage trial

Northstar Neuroscience says that a brain stimulation therapy intended to improve hand and arm function in stroke victims flunked a late-stage trial. Northstar's treatment uses electrical stimulation Read more...

Biovail shares sink after FDA schedules review

Shares of Biovail took a dive this morning after the company announced that the FDA expects to take six months to review its application for BFV-033, a once-daily version of buproprion, which is sold Read more...

FDA demands more data on Wyeth's Pristiq

Wyeth was effectively stiff-armed by the FDA in its application for Pristiq, the first non-hormonal therapy to treat menopausal symptoms. In an approvable letter, regulators told the company that Read more...
Tags: FDA   Wyeth   depression   FDA update   Pristiq   Menopause  

GlaxoSmithKline Statement - BBC Panorama

GlaxoSmithKline Statement - BBC Panorama

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Press Release: XTL Biopharmaceuticals And DOV Pharmaceutical In Deal Valued At More Than $130

Press Release: XTL Biopharmaceuticals And DOV Pharmaceutical In Deal Valued At More Than $130

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Epix anxiety drug fails in late-stage trial

Shares of Epix Pharmaceuticals slipped after the developer announced that a late stage trial of its experimental long-acting drug for general anxiety disorder failed to achieve a statistically significant response compared to a placebo. PRX-00023 was tested in a Phase III trial that enrolled 310 patients. "Based on these top-line results, we plan to refocus our efforts away from anxiety to evaluate the benefit in depression more closely and assess opportunities for initiating a Phase II …

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Dapoxetine proves effective in clinical trial

ALZA's dapoxetine demonstrated its safety and efficacy in a new clinical trial. Researchers at the University of Minnesota concluded that the study of 2,600 men increased the average duration of intercourse from less than a minute to three minutes and 19 seconds. If the drug is eventually approved, it would be the first therapy on the market specifically for PE and likely to enjoy a large market. Dapoxetine is an SSRI drug, a category that is typically used to treat depression. This …

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Tags: depression  

EPIX to buy Predix in $90M merger

EPIX Pharmaceuticals has inked a deal to buy Predix Pharmaceuticals in a deal valued at $90 million. Predix shareholders will wind up with 47 percent of the company and stand to earn an additional $35 million in milestones. The combined drug developer will have several advanced programs, including PRX-00023 in Phase III for anxiety and expected to enter Phase II for depression in 2007; EP-2104R in Phase II for imaging arterial and venous blood clots; PRX-03140, which has completed Phase …

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