Newron Pharmaceuticals SpA and its partner, Zambon SpA, remain on track to file for approval for safinamide as add-on therapy in Parkinson's disease in the fourth quarter, following the release of pivotal Phase III data at the annual meeting of the American Academy of Neurology in San Diego this week. Read More
Affymax Inc.'s stock-ravaging decision to let go 75 percent of its employees after the voluntary recall of Omontys (peginesatide) puts the spotlight ever more strongly on safety with regard to erythropoiesis-stimulating agents, and could bode well for Amgen Inc.'s anemia franchise. Read More
Briefing documents released ahead of a scheduled meeting March 21 of the Psychopharmacologic Drugs Advisory Committee sent shares of Titan Pharmaceuticals Inc. plummeting 41.7 percent Tuesday. Read More
The cannabis-based drug specialist GW Pharma plc has filed for a listing on Nasdaq, with the ambition of raising up to $50 million to turbo-charge development of its preclinical pipeline and expand manufacturing capacity in anticipation of the U.S. launch of its lead product Sativex. Read More
Investors took notice as InSite Vision Inc. reported positive top-line findings from its first Phase III trial of BromSite (ISV-303) for the reduction of inflammation and pain following cataract surgery. The company said BromSite, which combines a low dose (0.075 percent) of the nonsteroidal anti-inflammatory (NSAID) bromfenac with InSite's DuraSite drug delivery technology, achieved statistically significant superiority compared to vehicle. Read More
A lot of eyes were on the Supreme Court Tuesday as it considered arguments in Mutual Pharmaceutical Co. v. Bartlett, a case that could further define generic drug preemption or pave the way for more liability for all drugmakers. Read More
NPS Pharmaceuticals Inc. regained full worldwide rights to teduglutide (Gattex) and recombinant human parathyroid hormone 1-84 (PTH 1-84/Preotact) from Takeda Pharmaceutical Co. Ltd., of Osaka, Japan, in exchange for common stock valued at $50 million, plus a milestone payment of $30 million in cash or stock in the first year that net sales of both products exceed $750 million. Read More
• Stellar Biotechnologies Inc., of Port Hueneme, Calif., submitted a Type IV Biologics Master File to the FDA's Center for Biologics Evaluation and Research for its subunit Keyhole Limpet Hemocyanin (KLH). Read More
• Boehringer Ingelheim Pharmaceuticals Inc., of Ridgefield, Conn., part of Boehringer Ingelheim GmbH, said a new perspective from the FDA stated the agency has not changed its recommendations regarding Pradaxa (dabigatran etexilate mesylate) capsules, following the November 2012 Mini-Sentinel evaluations. Read More
• Impax Pharmaceuticals, of Hayward, Calif., a division of Impax Laboratories Inc., disclosed the presentation of results from its Rytary (IPX066) Phase III and open-label extension trials at the 65th Annual Meeting of the American Academy of Neurology in San Diego on March 18. Read More
• Boehringer Ingelheim Pharmaceuticals Inc., of Ridgefield, Conn., part of Boehringer Ingelheim GmbH, and Eli Lilly and Co., of Indianapolis, started a Phase IIIb trial to evaluate the glycemic efficacy and safety of linagliptin in patients with Type II diabetes with prevalent albuminuria. Read More
