Though decried as an overreaction by analysts at the time, Affymax Inc.'s intraday share drop earlier this month on reports of mild allergic reactions in a pilot study of erythropoiesis-stimulating agent (ESA) Omontys (peginesatide) turned out to be an omen of bad news to come. Read More
DUBLIN, Ireland – Shares in Elan Corp. plc (NYSE:ELNrose 5 percent to $11.14 Monday in response to an indicative $11 per-share takeover offer from Royalty Pharma. Read More
The FDA's complete response letter (CRL) for its Heplisav hepatitis B vaccine was no surprise to Dynavax Technologies Corp., of Berkeley, Calif., as it had extensive behind-the-scenes conversations with the FDA between the November advisory committee meeting and the CRL issued over the weekend. Read More
The notoriously challenging glioblastoma indication claimed another victim as EMD Serono reported that internally developed integrin inhibitor cilengitide failed to significantly improve overall survival (OS), the primary endpoint, in its Phase III CENTRIC trial investigating the agent when added to standard chemoradiotherapy (temozolomide and radiotherapy). Read More
Since the public pays for it, the public should have access to it. That's the reasoning behind a White House memo giving federal agencies six months to come up with a draft plan to make data from federally funded research publicly and freely accessible, while protecting intellectual property and other confidential information. Read More
• DelMar Pharmaceuticals Inc., of Vancouver, British Columbia, said it completed the fourth closing in a private placement consisting of approximately 2 million units of its securities to qualified accredited investors, for gross proceeds of approximately $1.6 million. Read More
• Dendreon Corp., of Seattle, reported that net product revenue for the year ended Dec. 31, 2012 was $325.3 million compared to $213.5 million in 2011. Read More
• Jennerex Inc., of San Francisco, and Lee's Pharmaceutical Holdings, of Hong Kong, expanded their existing development and commercialization partnership for Pexa-Vec (JX-594) in China. Read More
• Cel-Sci Corp., of Vienna, Va., reported that its partner, Orient Europharma Co. Ltd., of Taipei, Taiwan, added two additional Taiwanese clinical centers in Cel-Sci's Phase III head and neck cancer trial for Multikine (Leukocyte Interleukin, Injection), including the China Medical University Hospital, of Taichung, Taiwan, and the Buddhist Tzu Chi General Hospital, of Hualian, Taiwan. Read More
• Mylan Inc., of Pittsburgh, said subsidiary Mylan Pharmaceuticals Inc. began shipping fenofibrate capsules, the generic version of Antara (Lupin, Atlantis Holdings SA), following final approval from the FDA for its abbreviated new drug application. Read More
