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March 18, 2014
07:19 EDTMDVN, ALPMYMedivation, Astellas Pharma submit sNDA for XTANDI
Astellas Pharma (ALPMY) and Medivation (MDVN) announced the submission of a supplemental New Drug Application, or sNDA, to the FDA seeking approval of XTANDI capsules for the treatment of men with metastatic castration-resistant prostate cancer, or mCRPC, who have not received chemotherapy. XTANDI is currently approved for the treatment of patients with mCRPC who have previously received docetaxel chemotherapy. The sNDA application is based on the results from the Phase 3 PREVAIL trial evaluating XTANDI as compared to placebo in more than 1,700 chemotherapy-na´ve mCRPC patients. The marketing authorization application is expected to be submitted to the European Medicines Agency later this year.
News For MDVN;ALPMY From The Last 14 Days
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October 24, 2014
09:07 EDTALPMYAstellas Pharma says CHMP adopts positive opinion for Xtandi
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October 23, 2014
17:13 EDTMDVNMedivation licenses clinical stage anti-PD-1 modulatory monoclonal antibody
Medivation announced Medivation has licensed exclusive worldwide rights to CureTech's late-stage clinical molecule pidilizumab, an immune modulatory anti-PD-1 monoclonal antibody. Under the license agreement, Medivation will be responsible for all development, regulatory and commercialization activities for pidilizumab for all indications, including oncology. Under the terms of the license agreement, and depending on whether the guaranty from CBI is obtained, CureTech would receive an upfront payment of up to $5M from Medivation and would also be entitled to payments upon the attainment of certain development and regulatory milestones totaling $85M. In addition, CureTech would be eligible to receive sales based milestone payments totaling up to $245M, upon the achievement of certain annual worldwide net sales thresholds, and tiered royalties ranging from 4%-11% based on annual worldwide net sales.
October 20, 2014
07:20 EDTALPMYInternational Continence Society to hold annual meeting
ICS Annual Meeting 2014 is being held in Rio de Janeiro, Brazil on October 20-24.
October 14, 2014
08:05 EDTALPMYAstellas Pharma to collaborate with investigator at Harvard Medical School
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October 13, 2014
07:35 EDTALPMYCytokinetics announces development program update for CK-2127107
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