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ZymoGenetics has submitted a biologics license application (BLA) to the FDA for approval to market recombinant human thrombin (rhThrombin) as a general aid to achieving hemostasis during surgery.
Cardiome Pharma and its co-development partner, Astellas Pharma, have announced Astellas' resubmission to the FDA of the new drug application (NDA) for the intravenous formulation of vernakalant hydrochloride, an investigational new drug for the acute conversion of atrial fibrillation.
InterMune and its partner Roche have received approval of the European Clinical Trial Authorization to begin a study of ITMN-191, the NS3/4A protease inhibitor.
Crucell announced it has obtained regulatory approval to test the safety, tolerability and immunogenicity of its AdVac-based malaria vaccine it is currently developing in collaboration with the National Institute of Allergy and Infectious Diseases (NIAID), part of the NIH.
Panacos Pharmaceuticals has announced preliminary results from the first cohort of a Phase IIb study of bevirimat (PA-457) in patients failing HIV therapy due to drug resistance.
Human Genome Sciences (HGS) has initiated dosing in ACHIEVE 1, one of two pivotal Phase III clinical trials of Albuferon (albinterferon alpha 2b) in combination with ribavirin in treatment-naive patients with genotype 1 chronic hepatitis C. Albuferon is being developed by HGS and Novartis under an exclusive worldwide development and commercialization agreement.
Gilead Sciences has announced that its Phase III AIR-CF2 study of aztreonam lysine for inhalation for the treatment of people with cystic fibrosis (CF) who have pulmonary Pseudomonas aeruginosa met its primary efficacy endpoint -- the time to need for inhaled or intravenous (IV) antibiotics -- which was assessed by the onset of common symptoms predictive of a pulmonary exacerbation.
Northfield Laboratories has announced preliminary results from its pivotal Phase III trial assessing the safety and efficacy of PolyHeme, its human hemoglobin-based oxygen-carrying red blood cell substitute, in the treatment of severely injured and bleeding patients when blood is needed but not immediately available.