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BPCIA: Amgen Begins the Patent Dance With AbbVie
2015-12-08 00:56:18| Biotech - Topix.net
On November 25, 2015, Amgen Inc. announced it submitted its first biologics license application to the FDA under the Section 351 biosimilar approval pathway provided in the Biologics Price Competition and Innovation Act . Amgen's BLA seeks approval for its biosimilar of AbbVie's top-selling arthritis drug Humira .
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amgen
Amgen files application in Europe for expanded use of Kyprolis
2015-12-06 03:02:21| Biotech - Topix.net
Amgen submits a Variation to the Marketing Authorization Application to the European Medicines Agency seeking clearance for the use of Kyprolis , in combination with the corticosteroid dexamethasone, in adult multiple myeloma patients who have received at least one prior therapy. The data supporting the application was generated in the Phase 3 ENDEAVOR study that showed patients treated with Kyprolis plus dexamethasone achieved superior progression-free survival compared to patients who received Takeda's Velcade plus dexamethasone were diarrhea, anemia, fatigue, dyspnea , pyrexia and insomnia.
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Cytokinetics, Amgen drug shows promise in heart failure study
2015-11-09 05:29:58| Biotech - Topix.net
ORLANDO: An experimental heart failure drug being developed by Cytokinetics Inc and Amgen Inc demonstrated several beneficial cardiac function effects in a midstage clinical trial, according to data presented on Sunday. The trial of 448 patients with chronic heart failure already receiving optimal care tested a twice-a-day oral version of the drug, omecamtiv mecarbil, against a placebo over 20 weeks.
Drugmaker Amgen posts big increases in 3Q profit, sales
2015-10-29 04:14:49| Biotech - Topix.net
This Nov. 9, 2014 file photo shows signage outside the Amgen headquarters in Thousand Oaks, Calif. Amgen Inc. on Wednesday, Oct. 28, 2015 reported third-quarter profit of $1.86 billion.
Amgen, Cytokinetics Heart Failure Drug Succeeds In Mid-Stage Study
2015-10-28 08:39:05| Biotech - Topix.net
Amgen Inc and Cytokinetics Inc said on Tuesday their experimental drug for chronic heart failure showed significant improvement in cardiac function in the second part of a mid-stage study. The 448 patients in the trial were given an oral formulation of the drug omecamtiv mecarbil for 20 weeks and observed for 24 weeks, the companies said in a joint statement.
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