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June 1, 2014
17:03 EDTALPMY, MDVNNew England Journal of Medicine publishes results from Phase 3 PREVAIL trial
Astellas Pharma US , a U.S. subsidiary of Tokyo-based Astellas Pharma (ALPMY) and Medivation (MDVN) announced the online publication in the New England Journal of Medicine of the results from the Phase 3 PREVAIL trial, an international, randomized, double-blind, placebo-controlled clinical study of enzalutamide. The study evaluated the benefit and safety of enzalutamide in men with metastatic prostate cancer, who had few or no symptoms, that had progressed on luteinizing hormone-releasing hormone, LHRH, therapy or after bilateral orchiectomy. The paper, "Enzalutamide in Men with Metastatic Prostate Cancer Before Chemotherapy," appears in the June 1 online issue and the companies anticipate publication in a future print issue of the Journal. "The PREVAIL study results demonstrate that treatment with enzalutamide in men with metastatic castration resistant prostate cancer can decrease the risk of death, delay the growth or spread of metastatic prostate cancer, and delay the time to initiation of chemotherapy," said Tomasz M. Beer, M.D., F.A.C.P., professor of medicine and deputy director of the Knight Cancer Institute at Oregon Health & Science University, and co-principal investigator of the PREVAIL study. "We are delighted that the New England Journal of Medicine has chosen to publish these important results." A supplemental New Drug Application, sNDA, based on the PREVAIL results received a priority review designation from the U.S. Food and Drug Administration. The Prescription Drug User Fee Act, PDUFA, goal date is September 18. A variation application to amend the European Marketing Authorization Application based on the results of PREVAIL was validated for review by the European Medicines Agency on April 24.
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July 16, 2014
12:13 EDTALPMYBasilea says FDA grants QIDP designation for isavuconazole
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July 10, 2014
16:12 EDTMDVNMedivation names Dawn Svoronos as Chief Commercial Officer
Medivation (MDVN) announced Dawn Svoronos has been appointed as its chief commercial officer, reporting to David Hung, M.D., founder, CEO and president of Medivation. Svoronos currently is a member of Medivation's Board of Directors and is a former president of Europe and Canada for Merck & Co. (MRK), where she oversaw commercial operations in approximately 30 EU and EU accession countries. Svoronos will lead Medivation's commercial organization on an interim basis and will participate in the company's search for a permanent chief commercial officer. Cheryl Cohen, Medivation's former chief commercial officer, has left the company to pursue other opportunities.
July 9, 2014
12:20 EDTALPMYAstellas submits isavuconazole U.S. NDA
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