Approvable letter news from FierceBiotech
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ALSO NOTED: Medicines Company gets not approvable letter; Sun, Taro merger called off; and much more...
> The Medicines Company got a not approvable letter on an sNDA for an additional dosing regimen for Angiomax, a treatment of acute coronary syndromes initiated in the emergency department. Read more...
Discovery secures $60M financing deal
Struggling Discovery Labs signed a three year, $60 million financing deal with Kingsbridge Capital, a U.K.-based investment group. Kingsbridge will provide the capital through the purchase of newly Read more...
Wyeth gets approvable letter for bazedoxifene
The FDA handed Wyeth a third approvable letter for bazedoxifene, a treatment for postmenopausal osteoporosis. In the letter, the FDA said it needed more information concerning the incidence of stroke Read more...
Merck shelves study of cholesterol drug
Saying it had the wrong patient population, Merck has discontinued its ACHIEVE imaging study for its cholesterol drug MK-0524A. Its steering committee recommended a new imaging study that included a Read more...
ALSO NOTED: Salix gets approvable letter; Intermune drug hits the fast track; and much more...
> Should Fred Hassan (photo) give back his bonus? That's what Forbes is asking this week, saying that the Read more...
FDA delays Entereg decision
GlaxoSmithKline and Adolor's seemingly never-ending effort to win approval for Entereg has hit yet another delay. The FDA informed the companies that it would not make a decision by Saturday, the Read more...
Battered Discovery Labs tries to reassure investors
Discovery Laboratories is signaling investors to hang on for a few weeks more. After seeing its stock price go into meltdown mode Friday on the FDA's Read more...
FDA delays Discovery Labs approval
Discovery Labs has been dealt another blow in its quest to gain approval for Surfaxin, a treatment for premature infant respiratory distress syndrome. The FDA issued an Approvable Letter yesterday, Read more...
Drug work completed, Theravance cuts 40% of staff
Theravance announced that it is cutting 40 percent of its workforce now that it has finished work on its antibiotic telavancin. Telavancin is currently undergoing FDA review: in March the FDA Read more...
Endo pulls Frova app after mulling FDA response
Endo Pharmaceuticals says a close reading of a non-approvable letter from the FDA for Frova prompted officials to pull their request to gain approval for the short-term relief of menstrual migraine. Read more...
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