The FDA approved Lucentis (ranibizumab injection) for diabetic macular edema (DME), offering patients the first improvement on the standard-of-care in 25 years. Read More
Hoping to make shortages of critical drugs more the exception than the rule, the generic drug industry is diving into an initiative to give the FDA access to timely manufacturing data. Read More
The typical headache for drug developers is a drug that won't cross the blood-brain barrier. But researchers from the National Institutes of Health and Jenrin Discovery Inc. hope to find success by preventing that crossing. Read More
The rat has been a staple in drug research for decades. With well characterized immune systems that are more closely predictive of human conditions, rats make excellent lab testing subjects. But Open Monoclonal Technologies Inc. (OMT), a 2007 start-up based in Palo Alto, Calif., is elevating the rat's role in drug development with a fully human monoclonal antibody platform based on transgenic rats. Read More
• Intercept Pharmaceuticals Inc., of New York, said it completed a $30 million Series C preferred stock financing led by OrbiMed Advisors LLC, with existing majority investor Genextra S.p.A. also participating. Read More
• Genentech Inc., a South San Francisco-based member of the Roche Group, reported that Avastin (bevacizumab) plus radiation and temozolomide chemotherapy demonstrated a significant improvement in progression-free survival, a co-primary endpoint of the Phase III AVAglio study. Read More
• The U.S. Bankruptcy Court for the Southern District of New York approved a request by K-V Pharmaceutical Co., of St. Louis, Mo., for the use of cash collateral as part of its voluntary reorganization under chapter 11 of the U.S. bankruptcy code. Read More
• Pfizer Inc., of New York, reported that the combination of its Torisel (temsirolimus) and bevacizumab (Avastin, Genentech Inc.) failed to demonstrate superiority to bevacizumab plus interferon-alfa-2a in progression-free survival in the Phase III INTORACT trial. Read More
• Mylan Inc. said its subsidiary Mylan Pharmaceuticals, of Pittsburgh, received FDA approval of its abbreviated new drug application (ANDA) for lithium carbonate extended-release tablets USP, 450 mg, to treat manic episodes of manic depressive illness. The FDA also approved Mylan's ANDA for a generic version of Provigil (modafinil, Cephalon Inc.). Read More
Flu viruses come in two versions, influenza A and influenza B. To public health officials, influenza B viruses are less alarming than influenza A strains because they circulate largely in humans, which means they do not have the animal reservoirs that are necessary to cause a pandemic. But they do play an important part in the annual flu. Scientists from the Dutch Crucell Vaccine Institute and the Scripps Research Institute have identified three broadly neutralizing antibodies to influenza B viruses. Read More
