Array BioPharma Inc.'s p38-alpha kinase inhibitor, ARRY-797, hit its primary endpoint of reducing pain more than placebo in a Phase II proof-of-concept trial in 157 patients with knee pain due to osteoarthritis. Enrolled patients suffered moderate-to-severe pain in spite of the use of nonsteroidal anti-inflammatory drugs (NSAIDs). Read More
MAP Pharmaceuticals Inc. priced an underwritten public offering of 3.9 million shares of its common stock at $13.40 apiece, seeking to raise $52 million as the biotech prepares to resubmit the new drug application (NDA) for Levadex, its inhalation aerosol for the acute treatment of migraine. Read More
Just in recent weeks, beta-amyloid has gotten another round of bad press, with several studies providing fresh support for the idea that amyloids are a cause of Alzheimer's disease. Read More
WASHINGTON – Hoping it will merely be an exercise in emergency planning, the FDA, National Institutes of Health (NIH) and other federal agencies are being told to begin preparing for sequestration – the across-the-board budget cuts in discretionary spending that will be triggered in January if Congress fails to trim $1.2 trillion from the national deficit. Read More
• Depomed Inc., of Menlo Park, Calif., submitted a new drug application for Serada to the FDA. The extended-release formulation of gabapentin is in development to treat menopausal hot flashes. The company conducted three Phase III studies (BREEZE 1, 2 and 3), reporting in October 2011 that Serada achieved its primary BREEZE 3 endpoints at four weeks but faltered at 12 weeks, hitting the severity endpoint but failing to reduce frequency. Read More
• InSite Vision Inc., of Alameda, Calif., said it started enrollment in the first Phase III trial of BromSite (ISV-303) for the reduction of pain and inflammation after cataract surgery. Read More
• Watson Pharmaceuticals Inc., of Parsippany, N.J., said it received approval from the FDA for its abbreviated new drug application for Budesonide Inhalation Suspension 0.25 mg/2mL and 0.5 mg/2mL, the generic equivalent for London-based AstraZeneca plc's Pulmicort Respules. Read More
