As expected, Regeneron Pharmaceuticals Inc. submitted a biologics license application (BLA) to the FDA for its VEGF Trap-Eye (aflibercept ophthalmic solution) to treat the neovascular form of age-related macular degeneration (wet AMD). Regeneron's submission includes a request for priority PDUFA review. Read More
WASHINGTON – Despite a trickle of original applications for new drugs and biologics licenses submitted to the FDA last year, concerns about the drug pipeline drying up may be premature. Read More
Cytheris SA, of Paris, published data in Cell showing interleukin-7 (IL-7) was able to overcome many of the factors that thwart an effective immune response in diseases such as HIV infection and viral hepatitis. The study results also suggested how IL-7 therapy could be used to produce and expand specific T cells and promote a broad and durable immune-mediated antiviral response. Read More
Santarus Inc., of San Diego, and Pharming Group NV, of Leiden, the Netherlands, announced that Pharming has begun an international, multicenter, randomized, placebo-controlled Phase IIIb study evaluating the investigational drug Rhucin (recombinant human C1 inhibitor) for the treatment of acute attacks of angioedema in patients with hereditary angioedema. Read More
Buyout speculation fueled by the late January approval of depression drug Viibryd (vilazodone) – not to mention last week's chatter after President and CEO Drew Fromkin cancelled his presentation at BIO CEO – ended Tuesday with a resounding thud, as Clinical Data Inc. disclosed an offer much lower than its bullish analysts had expected. Read More
Gilead Sciences Inc. made its third major acquisition in the past eight months, buying privately held Calistoga Pharmaceuticals Inc., of Seattle, for $375 million cash and $225 million in potential milestones. Read More
