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News Breaks
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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November 25, 2014
16:13 EDTMDVNMedivation to names Joseph Lobacki as Chief Commercial Officer
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November 21, 2014
08:18 EDTMDVNMedivation management to meet with Deutsche Bank
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November 20, 2014
08:14 EDTMDVNMedivation management to meet with UBS
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November 19, 2014
07:09 EDTMDVNJefferies to hold a conference
2014 Global London Healthcare Conference is being held in London, England on November 19-20.
November 12, 2014
11:17 EDTMDVNLeerink major pharma & biotech analysts hold analyst/industry conference call
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November 11, 2014
15:43 EDTMDVNLeerink major pharma & biotech analysts hold analyst/industry conference call
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