Wading into Phase III waters with a new class of anemia drugs, FibroGen Inc. and partner Astellas Pharma Inc. hope to show benefit with their orally given drug not only in the condition related to chronic kidney disease (CKD), but also in hypertension and elevated cholesterol. Read More
LONDON – Scientists have tracked the cause of a rare genetic condition that causes muscular weakness to a mutation affecting neurotransmission. Read More
Cadence Pharmaceuticals Inc., of San Diego, dropped its exclusive option to acquire Redwood City, Calif.-based Incline Therapeutics Inc., leaving the specialty pharma free to be acquired by The Medicines Co., of Parsippany, N.J., for $185 million up front, plus regulatory and commercial milestones. Read More
• Algeta ASA, of Oslo, Norway, said partner Bayer AG, of Leverkusen, Germany, submitted a marketing authorization application to the European Medicines Agency for Alpharadin (radium-223 dichloride) for the treatment of castration-resistant prostate cancer patients with bone metastases. The submission triggers a €50 million (US$65.7 million) milestone payment under the firms' 2009 agreement, and it is based on positive data from the Phase III ALSYMPCA study, in which Alpharadin significantly increased overall survival by 44 percent. Read More
• Hepatera Ltd., of Moscow, a biotech company that is part of Maxwell Biotech Venture Fund's portfolio, said it enrolled the first three patients with chronic hepatitis B virus (HBV) in its Phase Ib/IIa study of Myrcludex B, a drug designed to inhibit the essential HBV receptor on the liver cell surface, preventing the infection of healthy cells and viral spreading in the liver. Results are expected by the end of 2013. Read More
• Takeda Pharmaceutical Co. Ltd., of Osaka, Japan, and H. Lundbeck A/S, of Copenhagen, Denmark, said the FDA accepted for filing the companies' new drug application for vortioxetine for the treatment of major depressive disorder in adults. A PDUFA date of Oct. 2, 2013, is anticipated. Takeda and Lundbeck also disclosed the proposed brand name of Brintellix for vortioxetine. Read More
• Eli Lilly and Co., of Indianapolis, provided an update on the next steps planned for solanezumab, its Phase III monoclonal antibody being studied as a potential therapy for patients with mild Alzheimer's disease. Read More
