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Amgen Inc (AMGN.O)

AMGN.O on Nasdaq

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29 Mar 2017
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Latest Key Developments (Source: Significant Developments)

Amgen enters into agreement with Inovalon and Avalere
Wednesday, 29 Mar 2017 07:55am EDT 

Inovalon Holdings Inc : Amgen enters into agreement with Inovalon and Avalere to engage value-based contracting opportunities . Inovalon Holdings Inc - agreement will focus specifically on Rheumatoid Arthritis (RA) . Inovalon Holdings - Co, Avalere Health will deploy data, analytics capabilities with OBCS to support development of obcs based on value of Amgen's products .Inovalon Holdings - co, Avalere Health, an Inovalon Company, will deploy data, to support further development of OBCS based on value of Amgen's products.  Full Article

European Commission approves Amgevita for treatment of certain inflammatory diseases
Thursday, 23 Mar 2017 04:00pm EDT 

Amgen Inc : European Commission approves Amgevita™ (biosimilar adalimumab) for the treatment of certain inflammatory diseases .Amgen Inc- approval from EC grants a centralized marketing authorization with unified labeling in 28 countries that are members of EU.  Full Article

Amgen Inc reports four-year follow-up results from Repatha Osler-1 study
Tuesday, 14 Mar 2017 04:15pm EDT 

Amgen Inc : Amgen Inc - four-year follow-up results from Repatha (evolocumab) Osler-1 study . Amgen Inc - Repatha, when added to standard of care (SOC), achieved median low-density lipoprotein cholesterol (LDL-C) reductions of 57 percent at four years .Amgen - Repatha, when added to SOC achieved median LDL-C reductions with no new safety concerns identified.  Full Article

Repatha demonstrates reduced need for apheresis in patients with high LDL cholesterol
Monday, 13 Mar 2017 09:00am EDT 

Amgen Inc : Repatha (evolocumab) demonstrates reduced need for apheresis in patients with high LDL cholesterol in phase 3 study . Amgen Inc - no new safety concerns were identified in this study .Amgen - positive top-line results from a phase 3 study evaluating Repatha in patients who were receiving apheresis to reduce low-density lipoprotein cholesterol.  Full Article

Amgen sets quarterly dividend of $1.15 per share
Tuesday, 7 Mar 2017 04:00pm EST 

Amgen Inc :Sets quarterly dividend of $1.15 per share.  Full Article

Coherus Biosciences says Amgen files trade secret action against company
Monday, 6 Mar 2017 07:00am EST 

Coherus Biosciences Inc : Coherus Biosciences Inc - Amgen has filed a trade secret action in California State Court on March 3, 2017 . Coherus Biosciences Inc - trade secret action alleges trade secret misappropriation and other claims against Coherus and other parties .Coherus Biosciences Inc - "reject theme of Amgen's complaint that Coherus has engaged, or is engaging, in a scheme to misappropriate trade secrets".  Full Article

Amgen announces positive results from planned overall survival analysis of phase 3 head-to-head ENDEAVOR trial
Tuesday, 28 Feb 2017 09:00am EST 

Amgen Inc : Announces positive results from planned overall survival analysis of phase 3 head-to-head ENDEAVOR trial . Says study met the key secondary endpoint of OS . Says phase 3 head-to-head trial showed Kyprolis significantly improved OS versus Velcade in relapsed/refractory multiple myeloma patients . Says adverse events observed in the updated analysis consistent with those previously reported for ENDEAVOR .Says plans to submit results to regulatory agencies worldwide to support potential label update to ENDEAVOR study results.  Full Article

Astrazeneca says will get $130 mln as milestone payment after Brodalumab approval
Thursday, 16 Feb 2017 07:01am EST 

Astrazeneca Plc : Partner Valeant Pharmaceuticals announced that US FDA has approved Siliq (Brodalumab) injection for treatment of adult patients with moderate-to-severe plaque psoriasis . Through a collaboration agreement, astrazeneca granted valeant exclusive license to develop and commercialise siliq globally, except in japan and certain other asian countries . Under terms of agreement, Astrazeneca will receive a milestone payment of $130 million from valeant at first regulatory approval . This milestone will be recorded in Astrazeneca financial statements as externalisation revenue .Following approval, Astrazeneca and Valeant will share profits from sale of siliq in US market..  Full Article

Regeneron pharmaceuticals says appeals court grants stay of permanent injunction for praluent
Wednesday, 8 Feb 2017 05:30pm EST 

Regeneron Pharmaceuticals Inc : Regeneron Pharmaceuticals Inc says appeals court grants stay of permanent injunction for praluent (alirocumab) during appeals process . Regeneron -Sanofi and Regeneron will continue marketing, selling and manufacturing praluent in U.S. during appeal process . Regeneron Pharmaceuticals Inc - injunction is not applicable outside U.S. or to clinical trials which are continuing as planned .Regeneron Pharmaceuticals Inc - anticipated launch of praluent in 15 additional countries in 2017.  Full Article

FDA approves Amgen's Parsabiv, first new treatment in more than a decade for secondary hyperparathyroidism in adult patients on hemodialysis
Tuesday, 7 Feb 2017 06:13pm EST 

Amgen Inc : FDA approves Amgen's Parsabiv™ (etelcalcetide), first new treatment in more than a decade for secondary hyperparathyroidism in adult patients on hemodialysis .Amgen Inc- Based on doses expected to be used in clinical practice, monthly costs of Parsabiv and Sensipar should be comparable.  Full Article

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BRIEF-FDA grants priority review for Amgen's Blincyto supplemental biologics license application

* FDA grants priority review for Amgen's Blincyto® (blinatumomab) supplemental biologics license application