Amylin Pharmaceuticals Inc. and Eli Lilly and Co. are calling it quits after a nearly decade-long collaboration on diabetes drug exenatide, a move that leaves Amylin positioned as a potentially hot takeover candidate, especially if the once-weekly version of the glucagon-like peptide-1 receptor agonist, Bydureon, finally clears FDA hurdles early next year. Read More
Stock in Targacept Inc. dropped 60.2 percent Tuesday on news that its Phase III RENAISSANCE trial of TC-5214 in depression failed to meet its primary endpoint of change on the Montgomery-Asberg Depression Rating Scale (MADRS) following eight weeks of treatment. Read More
Cancer immunotherapy firm TVAX Biomedical Inc. became the latest biotech to line up this year for an initial public offering, filing an S-1 on Monday and seeking to raise $40 million. Read More
The match Tranzyme Pharma Inc. struck with Bristol-Myers Squibb Co. (BMS) two years ago will continue to spark the discovery of potential new macrocyclic drug candidates – at least for an additional six months. Read More
• HUYA Bioscience International LLC, of San Diego, partnered with Shenzhen Polytechnic School of Applied Chemistry and Biotechnology to advance development of drugs discovered within the school. HUYA will have the right to first review of new candidates in exchange for its expertise in drug development and access to global partners. Read More
• Boehringer Ingelheim GmbH, of Ingelheim, Germany, said results from the SILEN-C3 Phase IIb study showed the potential for BI201335, its next-generation protease inhibitor, in combination with pegylated interferon and ribavirin, to shorten treatment duration to 12 weeks and to improve the likelihood of viral cure compared to the former traditional standard of care – pegylated interferon and ribavirin. Read More
• Celldex Therapeutics Inc., of Needham, Mass., initiated a Phase I study of CDX-1127 in patients with selected malignant solid tumors or hematologic cancers. A human monoclonal antibody that binds CD27, a co-stimulatory molecule on T cells, CDX-1127 is designed to activate patients' immune cells against their cancer. The Phase I study will test five escalating doses of CDX-1127 to determine dosing for future trials. The multisite, U.S. study will enroll about 30 patients in each of two arms – solid tumors or lymphomas/leukemias. Read More
• BioCryst Pharmaceuticals Inc., of Research Triangle Park, N.C., presented new Phase IIb results showing that BCX4208 in patients with gout who have failed to reach serum uric acid level (sUA) of < 6 mg/dL on allopurinol alone met the primary endpoint, defined as the proportion of patients with sUA < 6 mg/dL at day 85. The 279-patient study showed that, when added to allopurinol 300 mg, BCX4208 was superior to allopurinol plus placebo (p = 0.009). Read More
