New User:

-or-
Username:
Password:
Forgot your password?

Stock Market & Financial Investment News

News Breaks
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.
News For ALPMY;MDVN From The Last 14 Days
Sign up for a free trial to see the rest of the stories you've been missing.
October 31, 2014
05:13 EDTALPMY, MDVNMedivation, Astellas Pharma plan to initiate enzalutamide Phase 3 study
Medivation (MDVN) and Astellas announced plans to initiate a global Phase 3 clinical trial that will evaluate the efficacy and safety of enzalutamide in patients with high-risk, hormone-sensitive, non-metastatic prostate cancer that has biochemically recurred following definitive local therapy with radical prostatectomy and/or radiation therapy. Currently there is no prescription medicine specifically approved in the United States for these patients. The Phase 3 randomized, multi-national trial will be conducted at approximately 160 sites and is designed to enroll approximately 1,860 hormone-sensitive, non-metastatic men with biochemical recurrence following prostatectomy and/or radiation therapy that are at high risk for morbidity and mortality from prostate cancer. Patients will be randomized into three separate groups: enzalutamide plus leuprolide acetate, enzalutamide monotherapy, or placebo plus leuprolide acetate. Treatment with enzalutamide monotherapy will be open-label. Treatment with enzalutamide and placebo will be double-blind in combination with open-label leuprolide acetate. The primary endpoint of the trial is metastasis-free survival. The trial will evaluate enzalutamide at a dose of 160 mg to be taken orally once daily.
October 30, 2014
07:15 EDTALPMYASCO / ASTRO / IASLC to hold symposium
Subscribe for More Information
October 24, 2014
09:07 EDTALPMYAstellas Pharma says CHMP adopts positive opinion for Xtandi
Subscribe for More Information
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.

Sign up for a free trial to see the rest of the stories you've been missing.

I agree to the theflyonthewall.com disclaimer & terms of use