Shares in Biotie Therapies Oyj dropped nearly 10 percent Tuesday on news that Roche Holding AG decided not to exercise an option on its selective serotonin (5-hydroxytryptamine) receptor subtype 6 (5-HT6) antagonist SYN-120. Read More
When Amylin Pharmaceuticals Inc. received the "green light" from the FDA in January to market its glucagon-like peptide-1 (GLP-1) receptor agonist, Bydureon (exenatide), as an adjunct to diet and exercise for improving glycemic control in adults with Type II diabetes, little did anyone know the full reasons why it had taken the company three tries to get approval. Read More
WASHINGTON – A week ahead of its self-imposed July 4 deadline, the Senate overwhelmingly passed the FDA Safety and Innovation Act (FDASIA) Tuesday, reauthorizing PDUFA for another five years. Now all the user-fee package needs is the president's signature so it can go into effect Oct. 1. Read More
Although the findings seems counterintuitive considering the recent consolidation in biosciences, the fifth biennial Battelle/BIO State Bioscience Industry Development report, released last week at the BIO International Convention, indicated U.S. employment in the sector grew by 6.4 percent – or more than 96,000 jobs – between 2001 and 2010 compared to a 2.9 percent decline in overall U.S. private-sector jobs. Read More
• Cortex Pharmaceuticals Inc., of Irvine, Calif., completed a private placement of a nonconvertible secured promissory note of approximately $400,000 with Samyang Optics Co. Ltd., of Korea. The note will accrue interest at 12 percent annually and is subject to repayment at its maturity date of June 22, 2013, or any time on or after Dec. 22, at Samyang's request. Read More
• Medivir AB, of Huddinge, Sweden, initiated a collaboration with researchers at the Swedish University of Agricultural Sciences (SLU) to identify and develop drugs against antibiotic-resistant bacteria. Read More
• GTx Inc., of Memphis, Tenn., reported data from a Phase IIb study showing that enobosarm, a selective androgen-receptor modulator, may play a role in the management of cancer patients with muscle wasting by improving physical function. Of the 159 subjects randomized to the study, 103 had physical function assessed at both baseline and following 16 weeks of treatment. Read More