Vical Inc.'s stock-bashing Phase III failure against metastatic melanoma with Allovectin (velimogene aliplasmid) caused at least one analyst to question the plasmid DNA platform that is the subject of another late-stage program with Astellas Pharma Inc. in a separate indication, as well as independent efforts. Read More
Based on early evidence of efficacy in an initial cohort of 25 patients refractory to Avastin (bevacizumab, Roche AG unit Genentech Inc.), Celldex Therapeutics Inc. added an expansion cohort of approximately 75 patients to its Phase II ReACT study of rindopepimut in EGFRvIII (v3)-positive glioblastoma (GBM), seeking a better bead on the compound's potential activity in a refractory patient population. Read More
SHANGHAI – The announcement that China's largest pharmaceutical company will build the country's largest biotechnology research center in Wuhan is cementing the reputation of the Chinese city as a global biotech center. China National Pharmaceutical Group Corp. (Sinopharm) plans to build the center at the Wuhan National Bioindustry Base, also known as Biolake, in the city of Wuhan in Hubei Province. Read More
The FDA jumped the gun on clocking the five-year exclusivity of Belviq from the date it granted approval – a move that would rob the obesity drug of nearly a year of exclusivity, Eisai Inc. claimed in a recent citizen petition that asks the agency to reset the clock. Read More
Poised to file an investigational new drug application for its lipid drug MAT9001, Tarpon Springs, Fla.-based Matinas Biopharma Holdings Inc. raised $15 million in a private placement financing. Read More
Investors in Topotarget A/S got a dose of the jitters on news that its development partner, Spectrum Pharmaceuticals Inc., will delay its new drug application (NDA) filing of Topotarget's belinostat to the fourth quarter, pushing into next year the payment dates for two badly needed milestones. Read More
Creating more dangerous strains of flu viruses for research purposes is a double-edged sword. Researchers have developed a novel biocontainment strategy for such viruses. It consists of adding a gene that makes them a target for destruction in the human lung, but not the lungs of ferrets. Read More
• Advanced Cell Technology Inc. (ACT), of Marlborough, Mass., filed preliminary proxy materials with the SEC in connection with its 2013 annual stockholders meeting proposing, among other matters, to increase the authorized shares of its common stock to 3.75 billion from 2.75 billion. Read More
• Immunomedics Inc., of Morris Plains, N.J., said that the three Phase I trials evaluating the company's antibody-drug conjugates (ADCs) in patients with diverse solid tumors have now advanced to Phase II trials. Read More
• Teva Pharmaceutical Industries Ltd., of Jerusalem, and Perrigo Co., of Allegan, Mich., launched a generic equivalent to Temodar (temozolamide). Teva has agreed to manufacture, market and distribute the product in the U.S. Read More
