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November 4, 2012
12:25 EDTAMGNAmgen: Phase 3 EVOLVE trial results presented
Amgen announced results of the Phase 3 EVOLVE (EValuation Of Cinacalcet HCl Therapy to Lower CardioVascular Events) trial, which evaluated treatment with Sensipar®/Mimpara (cinacalcet) for the reduction of the risk of mortality and cardiovascular, CV, events among 3,883 patients with secondary hyperparathyroidism, HPT, and chronic kidney disease, CKD, receiving dialysis. The primary endpoint of the study was time to the composite event comprising all-cause mortality or first non-fatal CV event, including myocardial infarction, hospitalization for unstable angina, heart failure or peripheral vascular event. Although patients in the Sensipar/Mimpara arm experienced a seven percent reduction in the primary endpoint (Hazard Ratio 0.93, 95 percent CI 0.85 to 1.02, p=0.112), the results were not statistically significant, and the trial did not meet its primary endpoint in the intent-to-treat analysis. These data were published today in the New England Journal of Medicine and simultaneously presented at the American Society of Nephrology's Kidney Week.
News For AMGN From The Last 14 Days
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October 21, 2014
07:15 EDTAMGNFDA to hold workshop on breast cancer drug development
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October 20, 2014
07:19 EDTAMGNIBC Life Sciences to hold a conference
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October 19, 2014
15:56 EDTAMGNAmgen to aid in production method for Ebola drug ZMapp, Bloomberg says
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October 17, 2014
09:06 EDTAMGNAmgen files patent infringement lawsuit against Sanofi, Regeneron
Amgen (AMGN) announced that it filed a lawsuit in the United States District Court of Delaware against Sanofi (SNY), Aventisub, formerly doing business as Aventis Pharmaceuticals, and Regeneron Pharmaceuticals (REGN) for patent infringement of U.S. Patent Numbers 8,563,698, 8,829,165, and 8,859,741. These patents, which are owned by Amgen, describe and claim monoclonal antibodies to proprotein convertase subtilisin/kexin type 9, or PCSK9. By its complaint, Amgen seeks an injunction to prevent the infringing manufacture, use and sale of Sanofi and Regeneron's alirocumab, a monoclonal antibody targeting PCSK9. Sanofi and Regeneron recently announced that they have completed Phase 3 clinical trials on alirocumab and intend to pursue regulatory approval to market alirocumab in the U.S. Amgen previously announced submission of a Biologics License Application to the FDA for evolocumab, its own investigational human monoclonal antibody to PCSK9, for the treatment of high cholesterol, on Aug. 28.
October 14, 2014
11:23 EDTAMGNBIND Therapeutics and The Conference Forum hold a conference
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October 9, 2014
16:11 EDTAMGNAmgen blinatumomab granted priority review by FDA
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October 8, 2014
10:20 EDTAMGNAmgen biosimilar franchise underappreciated, says Piper Jaffray
After Amgen announced positive Phase 3 results for its biosimilar Humira in psoriasis, Piper Jaffray said it believes that Amgen's overall pipeline is underappreciated since the company's biosimilar franchise is generally not included in consensus estimates. The firm views Amgen as a top large cap picks and reiterate its Overweight rating on the stock.
09:16 EDTAMGNAmgen's ABP 501 for psoriasis shows positive Phase 3 results
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07:19 EDTAMGNCBI to hold a conference
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07:11 EDTAMGNEuropean Academy of Dermatology and Venereology to hold a conference
23rd EADV Congress is being held in Amsterdam, The Netherlands on October 8-12.

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