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Metabasis Therapeutics has initiated a Phase IIa clinical trial for MB07803, a product candidate being studied as a treatment for patients with Type 2 diabetes.
Genzyme and Bayer HealthCare have announced that a supplemental biologics license application (sBLA) for Campath has been submitted to the FDA to expand the current product label to include first-line treatment of B-cell chronic lymphocytic leukemia (B-CLL).
Transition Therapeutics announced that the FDA has granted fast-track designation to the company's investigational drug candidate AZD-103/ELND005, which is being developed in collaboration with Elan for the treatment of Alzheimer's disease.
Cerimon Pharmaceuticals announced it has begun enrolling patients in a Phase IIb clinical study, ARREST UC-1, of its lead product candidate basiliximab for the treatment of ulcerative colitis.
Portola Pharmaceuticals has received positive results from EXPERT, a Phase II study of its oral Factor Xa inhibitor, PRT054021, for the prevention of venous thromboembolism (VTE) following total knee replacement surgery.
Repros Therapeutics announced final results of a U.S. Phase II study of Proellex, an oral drug being developed to relieve symptoms of uterine fibroids.
Genelabs Technologies announced it has reached agreement with the FDA on a special protocol assessment (SPA) for a Phase III clinical trial of Prestara for the treatment of systemic lupus erythematosus.