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April 4, 2014
09:02 EDTAMGNAmgen announces analysis results of Phase 3 trial of talimogene laherparepvec
Amgen announced top-line results from the primary overall survival analysis of a Phase 3 trial in melanoma, which evaluated the efficacy and safety of talimogene laherparepvec for the treatment of unresected stage IIIB, IIIC or IV melanoma compared to treatment with subcutaneous granulocyte-macrophage colony-stimulating factor. Results showed that, while the primary end point of durable response rate was met, the secondary endpoint of OS was not met, although there was a strong trend in favor of talimogene laherparepvec. The estimated OS hazard ratio and improvement in median OS were similar to what was previously reported at the interim OS analysis. The most frequent adverse events observed in this trial were fatigue, chills and pyrexia. The most common serious adverse events include disease progression, cellulitis and pyrexia.
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August 31, 2014
12:50 EDTAMGNEuropean Society of Cardiology to hold a conference
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August 28, 2014
09:18 EDTAMGNAmgen anounces Evolocumab YUKAWA-2 study meets co-primary endpoints
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09:04 EDTAMGNAmgen submits evolocumab BLA to FDA
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August 27, 2014
09:20 EDTAMGNFDA grants Amgen priority review designation for ivabradine
Amgen announced the U.S. Food and Drug Administration has granted priority review designation for ivabradine for the treatment of chronic heart failure. Ivabradine is an oral drug that inhibits the If current in the sinoatrial node, the body's cardiac pacemaker. The New Drug Application is based on global clinical trial data from the Phase 3 SHIFT, or Systolic Heart failure treatment with the If inhibitor ivabradine Trial), study. The SHIFT study compared ivabradine to placebo on top of standard-of-care therapies, including beta-blockers, in more than 6,500 patients in sinus rhythm with reduced left ventricular function and heart rate greater than 70 beats per minute.
August 26, 2014
11:21 EDTAMGNAmgen added to short term buy list at Deutsche Bank
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August 25, 2014
16:17 EDTAMGNWestern Digital CFO Leyden to retire, Olivier Leonetti to succeed
Western Digital (WDC) announced that CFO Tim Leyden is retiring. He is being succeeded by Olivier Leonetti, who has served as vice president, finance at Amgen (AMGN) from 2011. Leyden will remain with the company through January 2015 in a transition role and advisory capacity to president and chief executive officer Steve Milligan and to Leonetti for an interim period to ensure a smooth transition. The changes are effective as of September 8.
August 19, 2014
05:11 EDTAMGNGamida Cell announces investment, option agreement with Novartis
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