The FDA issued a complete response letter to Impax Pharmaceuticals, of Hayward, Calif., a division of Impax Laboratories Inc., for Rytary (IPX066), indicating that a re-inspection of the company's Hayward facility pursuant to a warning letter issued in May 2011 is necessary before the new drug application (NDA) may be approved. Read More
A Deloitte Recap LLC analysis of 2012 biopharma dealmaking activity suggested a seller's market for Phase II assets, with median up-front cash of $35 million for market rights in transactions involving at least one major territory, up from a median of $30 million during the 2007-2011 time frame. However, market rights at other stages, including approval, lagged, as did the total deal flow. Read More
Autoimmune diseases are one area where it's a man's world. "Many autoimmune diseases are much more frequent in females," Jayne Danska told BioWorld Today. "That's been known for decades. But we don't have any insight into how to take that insight and do something useful for women with it." Read More
Newly established Dutch start-up Dezima Pharma BV in-licensed what it considers a best-in-class cholesteryl ester transfer protein (CETP) inhibitor, DEZ-001 (formerly TA-8995), from Osaka, Japan-based Mitsubishi Tanabe Pharma Corp. and is planning to move the cholesterol-lowering drug into a Phase II trial involving more than 400 patients in the coming months. Read More
• Sernova Corp., of London, Ontario, will make a nonbrokered private placement of $2 million to support use of its platform technology to develop therapies for diabetes and other diseases. Read More
• Progenics Pharmaceuticals Inc., of Tarrytown, N.Y., acquired Molecular Insight Pharmaceuticals Inc., of Cambridge, Mass. Under the terms of the all-stock transaction, Progenics exchanged about 4.5 million shares of its common stock (8.9 percent of the total outstanding post-transaction shares) for all of the outstanding shares of Molecular Insight, which will become a wholly owned subsidiary of Progenics. Read More
• Axelar AB, of Stockholm, Sweden, a Karolinksa Development AB portfolio firm, said an investigator-sponsored Phase I/II study started in the U.S. to test AXL1717, an oral small-molecule insulin-like growth factor 1 receptor inhibitor, in patients with malignant astrocytomas, a type of brain tumor. Read More
• CSL Behring, of King of Prussia, Pa., said it enrolled the first patient in the pivotal pediatric Phase III trial to test efficacy and pharmacokinetics of recombinant fusion protein. Read More
