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Genzyme and Berlex, a U.S. affiliate of Schering AG, have announced results from CAM307, an international, Phase III clinical trial comparing Campath (alemtuzumab) with chlorambucil in previously untreated patients with B-cell chronic lymphocytic leukemia (B-CLL).
Eculizumab, a novel monoclonal antibody drug developed by Alexion Pharmaceuticals, appeared to be safe and well-tolerated and provided clinically and statistically significant improvements in intravascular hemolysis, anemia, fatigue and quality of life in patients with paroxysmal nocturnal hemoglobinuria (PNH) during the 52 weeks of treatment in the Phase III SHEPHERD clinical trial.
Millennium Pharmaceuticals announced that the FDA has approved Velcade for the treatment of patients with mantle cell lymphoma (MCL) who have received at least one prior therapy.
Advanced Magnetics announced that its European partner, Guerbet, has submitted a marketing authorization application for Combidex to the European Medicines Agency (EMEA).
Medarex announced that the FDA has granted fast-track designation to ipilimumab used in combination with chemotherapy (dacarbazine) in previously untreated (first-line) metastatic melanoma patients.
Epix Pharmaceuticals has begun a Phase IIa clinical trial to further evaluate PRX-03140 as monotherapy and in combination with donepezil for the treatment of Alzheimer's disease.
GTx has announced that ostarine, a first-in-class selective androgen receptor modulator, met its primary endpoint in a Phase II, proof-of-concept, double-blind, randomized, placebo-controlled trial in 120 older subjects (60 older men and 60 postmenopausal women).
HRA Pharma has announced the start of a pivotal, multicenter, Phase III study evaluating its proprietary second-generation emergency contraceptive, Ella.
Genta has announced preliminary results from a randomized Phase III trial of chemotherapy with or without Genasense (oblimersen sodium) injection that was conducted in older, previously untreated patients with acute myelogenous leukemia (AML).