With an established reputation for its generic drugs, Mumbai, India-based Lupin Ltd. has expanded into biosimilars in its quest to become a global biopharma powerhouse. But like the foggy view from the 32nd-floor penthouse location of the Asia track at the J.P. Morgan Healthcare Conference Wednesday morning, the firm's chief financial officer provided limited insight into the company's biosimilars strategy despite audience questions. Read More
For an addict, melanoma cells can be pretty picky. About half of all melanomas result from mutations in the oncogene BRAF. Such tumor cells develop a so-called oncogene addiction, becoming dependent on BRAF for their survival. Read More
Despite a clinical setback in 2009, when two massive Phase III trials of cangrelor were halted for lack of apparent efficacy, the antiplatelet candidate is back on track, as The Medicines Co. reported positive results from a new Phase III study. Read More
• Synageva BioPharma Corp., of Lexington, Mass., closed a public offering of about 2.5 million shares of common stock, including 322,500 shares issued pursuant to an underwriters' option, at $47.53 per share. Read More
• Onconova Therapeutics Inc., of Newtown, Pa., partnered with GVK BIO, of Hyderabad, India, to develop products for two Onconova discovery targets through clinical stage. GVK BIO will contribute its discovery platform to advance the programs through lead optimization and candidate selection. Read More
• TapImmune Inc., of Seattle, said an interim safety analysis of the first five breast cancer patients treated with HER2/neu Class II antigens did not show any serious adverse events, so treatment of the remaining 17 patients in the Phase I study at the Mayo Clinic will progress. Read More
• The FDA issued a draft guidance document to assist industry in developing new formulations of opioid drugs with abuse-deterrent properties. The document, titled "Guidance for Industry: Abuse-Deterrent Opioids – Evaluation and Labeling," contains the agency's current thinking about the studies that should be conducted to demonstrate that a given formulation has abuse-deterrent properties. Read More
