Would-be competitors coming up quickly behind Biogen Idec Inc.'s Factor IX (rFIXFc) Fc fusion protein, along with an expectation of good news, may have combined to put a Wall Street damper on favorable Phase III results in hemophilia B, as investors looked ahead to Phase III data later this year in the larger market of hemophilia A with a separate molecule, rFVIIIFc. Read More
The White House issued a report Tuesday from the President's Council of Advisors on Science and Technology (PCAST) recommending a doubling in the output of new drugs over the next decade, while increasing drug efficacy and safety. The report cited scientific knowledge gaps between basic research and commercial projects and inefficiency in the conduct of clinical trials as primary causes of the burgeoning cost of drug development, without commensurate increases in drug approvals. Read More
Like Leonardo da Vinci's famously proportioned Vitruvian Man, from which Vitruvian BioMedical Inc. takes its name, the small biotech is seeking to find a balance in personalized medicine between optimized diagnostics and therapeutics. Read More
• Northwest Biotherapeutics Inc., of Bethesda, Md., effected a 1-for-16 reverse split. The split is the first step toward a planned public offering of up to $25 million, and listing on the Nasdaq Capital Market. Read More
• Amarantus Biosciences Inc., of Sunnyvale, Calif., said positive, peer-reviewed efficacy data for the anti-apoptotic therapeutic protein MANF in an animal model of myocardial infarction were published in The Journal of Biological Chemistry by the Glembotski Lab at the San Diego State University's biology department and the SDSU Heart Institute. Read More
• Pacira Pharmaceuticals Inc., of Parsippany, N.J., said it started a Phase II/III pivotal trial of pain drug Exparel (bupivacaine liposome injectable suspension) administered as a single-dose injection femoral nerve block for total knee arthroplasty surgery. Read More
• Boehringer Ingelheim GmbH, of Ingelheim, Germany, said it completed enrollment in two Phase III trials testing nintedanib (BIBF 1120) in patients with idiopathic pulmonary fibrosis. The identical studies will enroll a total of 970 patients to receive treatment or placebo over a 52-week period. Read More