Privately held Edison Pharmaceuticals Inc. wooed a big pharma partner, inking an R&D and commercialization agreement with Dainippon Sumitomo Pharma Co. Ltd. (DSP) to develop lead program EPI-743 and follow-on molecule EPI-589 in Japan. Read More
Scientists have discovered that normal brain activity induces DNA damage, and that such damage is induced more strongly, and repaired more slowly, in the brains of mice with Alzheimer's disease. The findings suggest new possibilities for fighting neuronal damage in Alzheimer's disease, and such DNA breaks may also be a newly discovered mechanism of memory storage under normal circumstances. Read More
Shares of Biogen Idec Inc. jumped more than 5 percent following an announcement late on Wednesday that the FDA approved Tecfidera (dimethyl fumarate) for relapsing forms of multiple sclerosis (MS). The drug was approved with a label in line with expectations with no black box warnings, just recommendations for baseline and annual white blood cell count monitoring. The greatest remaining question is pricing, which has not yet been announced, but which could affect how the drug performs upon entering in the market. Read More
• Pharming Group NV, of Leiden, the Netherlands, said it received approval from the European Medicines Agency for Sanofi Chimie to manufacture drug substance for Pharming's Ruconest (recombinant human C1 inhibitor) at its Aramon, France, site. Ruconest is approved in Europe for treating attacks in patients with hereditary angioedema. Read More
• ARCA Biopharma Inc., of Broomfield, Co., filed for a public offering of $20 million in stock and warrants to fund the Phase IIb portion of the GENETIC-AF trial of Gencaro (bucindolol hydrochloride) for atrial fibrillation. Dawson James Securities Inc. is the lead placement agent. Read More
• Biodel Inc., of Danbury, Conn., reported that enrollment has been completed in a Phase II study of its ultra-rapid-acting prandial insulin candidate BIOD-123. The study is evaluating the use of BIOD-123 vs. Humalog (insulin lispro, Eli Lilly and Co.) on measures of HbA1c, postprandial glucose excursions, glycemic variability, hypoglycemic event rates and weight changes in about 130 U.S. patients with Type 1 diabetes. Biodel expects to report top-line data from the trial in the third quarter. Read More
• GlaxoSmithKline plc, of London, recently agreed to a nonexclusive material transfer, patent and know-how license deal with the Health Protection Agency (HPA) for the development and manufacture of a next-generation polio vaccine. The agreement allows the HPA to contribute to global polio eradication, while securing a commitment from a major pharma firm to develop use of its technology. Read More
