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Ranbaxy Laboratories announced it has received approval from the FDA to manufacture and market generic loperamide hydrochloride and simethicone tablets, 2 mg/125 mg, for OTC use.
Genentech announced it received a complete response letter from the FDA for a supplemental biologics license application (sBLA) for Avastin with chemotherapy in first-line metastatic breast cancer.
Symphogen announced that the European Patent Office issued European Patent number 1,583,830, titled "Method for manufacturing recombinant polyclonal proteins."
Trophos announced that the European Commission granted the company orphan drug designation for Cholest-4-en-3-one, oxime, (TRO19622) as a treatment for amyotrophic lateral sclerosis (ALS).
Scios, a Johnson & Johnson (J&J) company, announced the selection of Duke Clinical Research Institute as the independent academic research organization that will lead the ASCEND-HF (Acute Study of Clinical Effectiveness of Nesiritide in Decompensated Heart Failure) trial.
Northwest Biotherapeutics has received FDA clearance to proceed with Phase I testing of its personalized therapeutic cancer vaccine, DCVax-LB, in non-small-cell lung cancer.
Medarex and the University of Massachusetts Medical School have begun a randomized, double-blind, placebo-controlled Phase II trial of CDA-1 and MDX-1388, two fully human monoclonal antibodies developed to Clostridium difficile (C. difficile) toxin A and toxin B, respectively, for the treatment of C. difficile associated diarrhea (CDAD).
Cipher Pharmaceuticals announced preliminary results from a Phase III study of CIP-TRAMADOL ER, an extended-release capsule formulation of the pain medication tramadol.