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News Breaks
June 2, 2014
07:48 EDTAMGNAmgen presents new data that support potential of talimogene laherparepvec
Amgen announced new data from two key clinical trials that support the potential of talimogene laherparepvec, a novel, investigational oncolytic immunotherapy, as both a single agent and as part of a combination regimen in patients with metastatic melanoma. Data from the 19 patients in the Phase 1b combination study showed no dose-limiting toxicities with talimogene laherparepvec in combination with ipilimumab. Additionally, tumors either shrank in size or were no longer detectable in 56 percent of patients when talimogene laherparepvec was given prior to and in combination with ipilimumab. The most common adverse events observed were chills, fevers, rash and fatigue. The pivotal Phase 3 trial met its primary endpoint showing a statistically significant improvement in durable response rate. Detailed results of the overall survival analysis, a key secondary endpoint of the pivotal Phase 3 trial evaluating talimogene laherparepvec as a single agent, were also presented. The results demonstrated a 4.4 month improvement in overall survival which closely approached statistical significance in the total patient population tested that included patients with and without visceral tumors.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.
News For AMGN From The Last 14 Days
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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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August 18, 2014
17:25 EDTAMGNAmgen announces AMG 416 study met its primary and all secondary endpoints
Amgen announced that a second placebo-controlled Phase 3 study evaluating AMG 416 for the treatment of secondary hyperparathyroidism, SHPT, in patients with chronic kidney disease,CKD, receiving hemodialysis, met its primary and all secondary endpoints. "The results from this second Phase 3 study help to confirm that AMG 416 could become an important new treatment option for dialysis patients with secondary hyperparathyroidism," said Sean E. Harper, M.D., executive vice president of Research and Development at Amgen. "Despite the variety of options available for the treatment of this disease, an unmet need remains for an intravenous therapy that can be administered along with hemodialysis. We look forward to sharing results of a head-to-head study evaluating AMG 416 compared to cinacalcet next year."

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