Food & Drug Law Weekly
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Bioenvision
European marketing approval sought for Clofarabine
September 24th, 2004
Bioenvision (BIVN) announced that it has submitted a Marketing Authorization Application for clofarabine to the European regulatory authorities. Using the European Centralized Procedure, the application will be evaluated for the treatment of refractory or relapsed acute leukemias in children. The EMEA accepted and validated the application and has commenced a marketing authorization review for clofarabine. The filing was primarily based upon data from two pivotal phase II trials of clofarabine in children with relapsed or refractory acute lymphoblastic leukemia (ALL) and acute myeloid leukemia (AML). The trial results were presented at the 40th...
Source: Food & Drug Law Weekly (2004-09-24)
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