Failed biotech Viragen Inc. might have called it quits in 2007, but its monoclonal antibody targeting CD55 was reborn in start-up Genesis Biopharma Inc., which licensed the CD55-related assets earlier this year and plans to move forward with testing in both solid tumors and blood cancers. Read More
The Institute for OneWorld Health (iOWH) has a novel business model: The nonprofit pharmaceutical company was founded in 2000 to pursue promising drug candidates that have been discarded by for-profit companies for lack of a viable market. Read More
• Orexo AB, of Uppsala, Sweden, said partner Boehringer Ingelheim GmbH, of Ingelheim, Germany, selected a development candidate from the firms' 2005 collaboration focused on pain and inflammatory diseases. That selection triggered a €6.5 million (US8.6 million) milestone payment to Orexo. Read More
• Neuralstem Inc., of Rockville, Md., said the FDA approved its investigational new drug application for a Phase Ia trial of NSI-189, a small molecule designed to stimulate new neuron growth in the hippocampus for treating major depression. The study will test a single dose of the drug in healthy patients. If safety endpoints are met, the trial will move to a Phase Ib portion, testing the safety of escalating doses of daily administration for 28 days in depressed patients. The entire Phase I trial is expected to take about one year. Read More
• Provesica Ltd., of Cambridge, UK, received £4 million (US$6.2 million) from Forbion Capital Partners and Seroba Kernal Life Sciences Ltd. to advance its overactive bladder program through to the completion of a Phase II trial in 2011. Read More
WASHINGTON – The FDA Thursday said it wants the HER2-negative metastatic breast cancer indication stricken from the labeling of Genentech Inc.'s Avastin (bevacizumab), which gained accelerated approval in February 2008 as a first-line treatment in combination with paclitaxel for the disease. Read More
Obesity's "big three" are top of mind these days, thanks to recent FDA panel rejections and upcoming FDA decision dates for Arena Pharmaceuticals Inc.'s Lorqess (lorcaserin) and Vivus Inc.'s Qnexa (phentermine/topiramate), as well as a pending panel for Orexigen Therapeutics Inc.'s Contrave (naltrexone SR/bupropion SR). Read More
