Biogen Idec Inc.'s hiccup in the European launch of Tecfidera (dimethyl fumarate), known as BG-12 in trials, sparked a mild kerfuffle among analysts trying to figure out the status of intellectual property (IP) protection for the multiple sclerosis (MS) therapy approved in the U.S. earlier this year. Read More
Oncothyreon Inc., of Seattle, will plunk down $10 million up front upon initiation of a new collaboration with Array BioPharma Inc., of Boulder, Colo., around ARRY-380, a small-molecule inhibitor of HER2, which according to the company is the only one in development. Read More
"Mind the gap" was the warning call Thursday as the FDA's symposium on medical countermeasures (MCMs) turned to the need for pediatric countermeasures for radiation exposure. Read More
GHENT, Belgium – The pharmaceutical industry has enjoyed 60 years of stability and is now – whether it likes it or not – ripe for disruption. That was the main message Bernard Munos, of InnoThink Center for Research in Biomedical Innovation in Indianapolis, delivered to delegates at a heavily attended keynote at the Knowledge for Growth meeting here at the International Convention Center. Read More
• 3SBio Inc., of Shenyang, China, said it completed its merger with Decade Sunshine Ltd., an exempted company with limited liability incorporated under the laws of the Cayman Islands. The firm also requested that trading of its American depositary shares on Nasdaq be suspended, while it works to delist its registered securities. Read More
• Teva Pharmaceutical Industries Ltd., of Jerusalem, said the FDA accepted for review the company's supplemental new drug application for Copaxone (glatiramer acetate injection) 40 mg/1mL, a higher concentration dose designed to offer a less frequent three-times-per-week dosing schedule for patients with relapsing-remitting multiple sclerosis. Read More
• AstraZeneca plc, of London, developed AZD3965, which Cancer Research UK's development office said will enter a 63-patient trial to determine its potential benefit. Read More
• ARCA Biopharma Inc., of Broomfield, Colo., priced a public offering that includes approximately 125,000 shares of Series A convertible preferred stock and warrants to purchase approximately 6.25 million shares of common stock, with each share of preferred stock and related warrants priced at $160. Read More
• PharmAthene Inc., of Annapolis, Md., said the FDA lifted the clinical hold placed on a proposed Phase II study of SparVax, a next-generation recombinant anthrax vaccine. In a letter to the company, the FDA acknowledged that PharmAthene had satisfactorily addressed all of the agency's clinical hold issues and that the hold had been lifted, effective immediately. Read More