Shares in Zealand Pharmaceuticals A/S hit an all-time high Monday on news that it will shortly start logging double-digit percentage royalty payments from its partner Sanofi SA, following formal European Union approval of the once-daily glucagon-like peptide 1 (GLP-1) agonist Lyxumia (lixisenatide, AVE0010) in Type II diabetes. Read More
Israeli biotech Gamida Cell Ltd. moved lead product StemEx one step closer to becoming potentially the first allogeneic biologic cell product to achieve marketing approval in the U.S. and Europe. Read More
Stem cells are supposed to be the fountain of youth for other tissues. But stem cells themselves age, too, meaning that sooner or later, the fountain of youth could use some rejuvenation itself. Read More
The FDA convened a public hearing to receive input on its proposal to expedite development of new drugs for serious or life-threatening conditions with unmet need. The pathway, which is being considered primarily for development of agents to combat antibiotic-resistant infections, would involve smaller, faster clinical trials with narrow, tightly enforced labeling for use in patients without other options. Read More
The Medicines Co. likes Alnylam Pharmaceuticals Inc.'s RNA interference (RNAi) approach to blocking proprotein convertase subtilisin/kexin type 9 (PCSK9) enough to pay $25 million up front plus as much as $180 million in milestone payments, but how the method might stand up against late-stage antibodies remains to be seen clinically. Read More
• NewLink Genetics Corp., of Ames, Iowa, said underwriters of its recently announced public offering of 4 million shares of common stock have exercised in full their option to purchase an additional 600,000 shares. Read More
• Bionomics Ltd., of Adelaide, Australia, presented new data on BNC375, its drug candidate with potential for the treatment of memory loss in Alzheimer's disease, at the 33rd Annual Meeting of the Australian Neuroscience Society in Melbourne, Australia. Read More
• BrainStorm Cell Therapeutics Inc., of New York, began treating its first patient in a Phase IIa trial of its stem cell therapy in amyotrophic lateral sclerosis. Three groups of four patients will be treated with intramuscular and intrathecal administration of NurOwn cells, in increasing doses. Read More
• Covidien plc, of Dublin, Ireland, said that its pharmaceutical business, Malinckrodt plc, of Hazelwood, Mo., filed a registration statement with the SEC in connection with Covidien's plan to spin off. Read More
