• AtheroNova Inc., of Irvine, Calif., completed its pre-investigational new drug application meeting with the FDA for AHRO-001 in the prevention and regression of atherosclerotic plaque.• Emerald BioStructures, of Bainbridge Island, Wash., reported a three-year extension of its ongoing collaboration with Brussels, Belgium-based UCB SA, started in 2009, which will provide Emerald with research funding over the three-year period and the opportunity to receive milestones and royalties on future drug product revenues. Read More
• Adventrx Pharmaceuticals Inc., of San Diego, said it reached an agreement with the FDA on a single pivotal trial for ANX-514 (docetaxel for injectable emulsion) in cancer. The 400-patient study will be a noninferiority design with a primary endpoint of comparing fluid retention following treatment with ANX-514 administered without corticosteroid premedication, vs. Taxotere (docetaxel) administered with corticosteroid premedication. ANX-514 is designed to improve the tolerability and safety of docetaxel and decrease toxicities. Read More
PHILADELPHIA – With lengthy development cycles and the increasing costs of clinical work, well-established therapeutics sitting on pharmaceutical company shelves may be the lowest hanging fruit.The question is: Who is going to pay for them? Big pharmas are challenged to bring all of the promising products to market, despite budget constraints; biotechs are challenged to find funding for their own technologies; and venture capital firms are challenged to get returns on investments. Read More
WASHINGTON – Still in the dark about how the government wants them to collect data about their payments to doctors beginning Jan. 1, 2012, drugmakers are seeking a little leniency and some swift clarity about what's expected of them under the Physicians Payment Sunshine provision.Since the Department of Health and Human Services (HHS) missed its Oct. Read More
Ahead of schedule, on Wednesday Onyx Pharmaceuticals Inc. and partner Bayer HealthCare Pharmaceuticals reported positive Phase III data for the VEGF-multikinase inhibitor regorafenib (BAY 73-4506) in patients with metastatic colorectal cancer (mCRC) whose disease has progressed after standard treatment.While keeping details under wraps, the companies said the trial met its primary endpoint of statistically significant improvement in overall survival. Read More
SAN FRANCISCO – The final day of the 2011 BIO Investor Forum started with some encouraging news: The discovery-stage deal is alive and well for biotech.In the last two months alone, BioWorld Today has reported on several deals, including Ipsen SA's multi-asset deal with Syntaxin Ltd. for botulinum toxin drugs; Merck Serono SA's potential $691 million inflammatory disease antibody collaboration with F-Star GmbH; and Merck & Co. Inc. becoming the first major commercialization partner in an early stage deal for Zymeworks Inc.'s bi-specific antibody technology. Read More
