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Amgen Inc (AMGN.O)

AMGN.O on Nasdaq

184.12USD
19 Oct 2017
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Latest Key Developments (Source: Significant Developments)

Amgen and Boston Children's Hospital enter into neuroscience research collaboration
Monday, 16 Oct 2017 04:00pm EDT 

Oct 16 (Reuters) - Amgen Inc :Amgen - co, Boston Children's Hospital entered into neuroscience research collaboration aimed at identifying novel pain targets.Amgen Inc - ‍one-year collaboration will focus on patients with genetic anomalies of pain sensitivity​.  Full Article

U.S. Appellate Court rules Sanofi, Regeneron can continue manufacturing PRALUENT in U.S.
Thursday, 5 Oct 2017 12:30pm EDT 

Oct 5 (Reuters) - Sanofi SA ::Appellate Court orders a new trial and vacates permanent injunction in ongoing patent case regarding Praluent® (alirocumab).‍Sanofi - co and Regeneron do not anticipate any new trial proceedings to start in 2017.Sanofi says U.S. Court of Appeals ruling means that co, Regeneron will continue marketing, selling, manufacturing Praluent (alirocumab) injection in U.S.‍Sanofi - Court has ordered new trial, vacated permanent injunction in dispute concerning Amgen's asserted patent claims for antibodies targeting PCSK9​.  Full Article

Amgen and AbbVie agree to settlement allowing commercialization of Amgevita
Thursday, 28 Sep 2017 08:00am EDT 

Sept 28 (Reuters) - Amgen Inc :Amgen and AbbVie agree to settlement allowing commercialization of Amgevita.Amgen Inc - Amgen expects to launch Amgevita in Europe on Oct. 16, 2018, and Amjevita in United States on Jan. 31, 2023.​.Says to begin launching biosimilar adalimumab in Europe in 2018​​.Amgen Inc - ‍under terms of agreement, AbbVie will grant patent licenses for use and sale of Amgevita/Amjevita worldwide, on a country-by-country basis​.Says Amgen and AbbVie have agreed to dismiss all pending litigation​.Says ‍specific financial terms of agreement were not disclosed​.  Full Article

Amgen provides update on Hurricane Maria
Monday, 25 Sep 2017 09:00am EDT 

Sept 25 (Reuters) - Amgen Inc :Amgen provides update on Hurricane Maria.Amgen Inc - preliminary assessment is that critical manufacturing areas in facility in Juncos, Puerto Rico, not been significantly impacted by storm​.Amgen inc - ‍having completed an initial review of storm's impact, company reaffirms its 2017 guidance​.FY2017 earnings per share view $12.57, revenue view $22.84 billion -- Thomson Reuters I/B/E/S.  Full Article

U.S. FDA approved Amgen's Mvasi as a biosimilar to Avastin
Thursday, 14 Sep 2017 12:31pm EDT 

Sept 14 (Reuters) - U.S. FDA :U.S. FDA says approved Amgen's Mvasi (bevacizumab-awwb) as a biosimilar to Avastin (bevacizumab) for the treatment of multiple types of cancer.‍U.S. FDA says Mvasi is approved for the treatment of adult patients with certain colorectal, lung, brain, kidney and cervical cancers​.  Full Article

Adello Biologics says FDA accepts for review co's Biologics License Application for proposed filgrastim biosimilar
Monday, 11 Sep 2017 12:30pm EDT 

Sept 11 (Reuters) - Adello Biologics::FDA accepts Adello Biologic's biosimilar biologics license application for a proposed filgrastim biosimilar.U.S. FDA has accepted for review co's Biologics License Application (BLA) for a biosimilar candidate referencing neupogen (filgrastim)​.  Full Article

Temasek Holdings takes stake in JPMorgan, Biogen, Celgene
Monday, 14 Aug 2017 09:05am EDT 

Aug 14 (Reuters) - Temasek Holdings (Private) Ltd::Temasek Holdings (Private) Ltd takes share stake in JPMorgan Chase & Co of 264,337 shares.Temasek Holdings takes share stake in Biogen Inc of 95,226 shares - SEC filing.Temasek Holdings takes share stake of 206,187 shares in Celgene Corp.Temasek Holdings takes share stake of 151,310 shares in Amgen Inc.Temasek Holdings ups share stake in Royal Dutch Shell Plc to 2.4 million class B sponsored ADR shares from 408,543 class B sponsored ADR shares.Temasek Holdings ups share stake in Regeneron Pharmaceuticals by 40.5 percent to 177,553 shares.Temasek Holdings : change in holdings are as of June 30, 2017 and compared with the previous quarter ended as of March 31, 2017.  Full Article

Cytokinetics announces positive results from phase 2 trial of Omecamtiv Mecarbil
Wednesday, 2 Aug 2017 07:30am EDT 

Aug 2 (Reuters) - Cytokinetics Inc ::Cytokinetics announces positive results from phase 2 clinical trial of Omecamtiv Mecarbil in Japanese patients with heart failure.Cytokinetics announces positive results from phase 2 clinical trial of Omecamtiv Mecarbil in Japanese patients with heart failure.Cytokinetics inc - ‍company is eligible to earn $10 million milestone payment from amgen upon first patient dosing in Japan in phase 3 outcomes trial​.Cytokinetics inc - ‍phase 2 clinical trial of Omecamtiv Mecarbil in Japanese patients with heart failure has met its pharmacokinetic primary endpoint​.Cytokinetics inc - ‍phase 2 clinical trial demonstrated statistically significant improvements in systolic ejection time (set), a secondary endpoint​.Cytokinetics inc - ‍cytokinetics is eligible to earn a $10 million milestone payment from amgen upon first dosing of a patient in Japan in Galactic-Hf​.  Full Article

Amgen submits supplemental biologics license application for Prolia in glucocorticoid-induced osteoporosis
Monday, 31 Jul 2017 09:10am EDT 

July 31 (Reuters) - Amgen Inc :Amgen submits supplemental biologics license application for Prolia® (denosumab) in glucocorticoid-induced osteoporosis.Amgen Inc - ‍Submission of a supplemental biologics license application to U.S. Food and Drug Administration for Prolia​.Amgen - Results from phase 3 study in SBLA submission showed treatment with Prolia for 12 months led to statistically significant greater gains in BMD.Amgen- ‍SBLA based on a phase 3 study evaluating safety and efficacy of Prolia compared with risedronate in patients receiving glucocorticoid treatment​.Amgen Inc - Adverse events and serious adverse events (SAES) were similar across treatment groups and consistent with known safety profile of Prolia.  Full Article

Amgen and Allergan submit biosimilar Biologics License application for ABP 980 to U.S. FDA
Monday, 31 Jul 2017 09:00am EDT 

July 31 (Reuters) - Amgen Inc :Amgen and Allergan submit biosimilar Biologics License Application for ABP 980 to US Food and Drug Administration.Amgen - Co and Allergan are collaborating on four oncology biosimilar medicines, including ABP 980 which is second to be submitted for FDA approval​.  Full Article

BRIEF-Amgen and Boston Children's Hospital enter into neuroscience research collaboration

* Amgen - co, Boston Children's Hospital entered into neuroscience research collaboration aimed at identifying novel pain targets