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Amgen Inc (AMGN.OQ)

AMGN.OQ on NASDAQ Stock Exchange Global Select Market

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Latest Key Developments (Source: Significant Developments)

Amgen says FDA accepts sBLA to expand indication for XGEVA
Monday, 19 Jun 2017 09:00am EDT 

June 19 (Reuters) - Amgen Inc :FDA accepts Amgen's supplemental biologics license application to expand indication for XGEVA (denosumab) to include multiple myeloma patients.Amgen Inc - FDA sets PDUFA target action date of Feb. 3, 2018.  Full Article

Coherus to take nearly 6 months to respond to FDA's requests on Neulasta biosmilar
Monday, 12 Jun 2017 09:30am EDT 

June 12 (Reuters) - Coherus BioSciences Inc -:Coherus BioSciences Inc says the agency can take up to 6 months to evaluate the requested information.Coherus Biosciences Inc says it will generate responses to the complete response letter within 6 months: conf call.  Full Article

Amgen submits Biologics License Application to the FDA for erenumab
Thursday, 18 May 2017 09:00am EDT 

May 18 (Reuters) - Amgen Inc :Amgen submits biologics license application to the fda for erenumab.Amgen inc says bla includes data from pivotal studies in patients with episodic and chronic migraine.Amgen inc - announced submission of a biologics license application to u.s. Food and drug administration for erenumab to prevent migraine.  Full Article

Feldan Therapeutics and Elasmogen announce research agreement with Amgen
Tuesday, 9 May 2017 08:19am EDT 

May 9 (Reuters) - Amgen Inc : :Feldan Therapeutics and Elasmogen announce research agreement with Amgen to develop intracellular biologics.Feldan Therapeutics-co, Elasmogen announce research collaboration to develop delivery system, binding domains to 2 undisclosed intracellular targets for Amgen.  Full Article

Amgen files for potential five-part senior notes offering
Monday, 8 May 2017 08:49am EDT 

May 8 (Reuters) - Amgen Inc :Amgen inc files for potential five-part senior notes offering - sec filing.  Full Article

Amgen optimistic for Enbrel sales rebound
Wednesday, 26 Apr 2017 06:21pm EDT 

April 26 (Reuters) - Amgen Inc :Amgen says optimistic about rebound in Enbrel sales in coming quarters after Q1 decline.Amgen says Enbrel will be significant cash flow generator for many years to come.  Full Article

Amgen reports Q1 GAAP earnings per share $2.79
Wednesday, 26 Apr 2017 04:04pm EDT 

April 26 (Reuters) - Amgen Inc :Q1 GAAP earnings per share $2.79.Q1 non-GAAP earnings per share $3.15.Q1 revenue down 1 percent to $5.46 billion.Says 2017 earnings per share guidance increased to $10.64-$11.32 on GAAP basis, and $12.00-$12.60 on non-GAAP basis.Says 2017 total revenue guidance unchanged at $22.3 billion to $23.1 billion.Sees 2017 capital expenditures to be about $700 million.Q1 earnings per share view $3.00, revenue view $5.60 billion -- Thomson Reuters I/B/E/S.FY2017 earnings per share view $12.35, revenue view $23.01 billion -- Thomson Reuters I/B/E/S.  Full Article

Amgen reports Q1 non-gaap earnings per share $3.15
Wednesday, 26 Apr 2017 04:04pm EDT 

April 26 (Reuters) - Amgen Inc :Amgen reports first quarter 2017 financial results.Q1 revenue fell 1 percent to $5.5 billion.Q1 non-gaap earnings per share $3.15.Q1 gaap earnings per share $2.79.Sees fy 2017 revenue $22.3 billion to $23.1 billion.  Full Article

Amgen announces expanded commercial collaboration with Novartis for erenumab in migraine
Monday, 24 Apr 2017 04:30pm EDT 

April 24 (Reuters) - Amgen Inc ::Amgen announces expanded commercial collaboration with Novartis for erenumab in migraine.Says co, Novartis agreed to combine capabilities to co-commercialize erenumab in U.S.; Amgen retains exclusive commercialization rights in Japan.Says Novartis gains exclusive rights to commercialize erenumab in Canada, retains existing commercialization rights in rest of the world.Says co will receive milestone payments from Novartis expected to begin in 2017; Novartis will share u.s. Commercialization costs with Amgen.Says co will book sales of erenumab in the U.S., and will pay a royalty to Novartis on net sales in the u.s..Says Novartis to book sales in rest of the world (excluding Japan), to pay co royalties on net sales in those countries; co to book sales in Japan.Says Novartis will assume agreed upon remaining global development costs up to a cap and share global development costs thereafter.  Full Article

Amgen submits applications in the U.S. and Europe to expand current indication for xgeva
Tuesday, 4 Apr 2017 09:00am EDT 

Amgen Inc : Amgen submits applications in the us and europe to expand current indication for xgeva® (denosumab) to include patients with multiple myeloma .Amgen Inc - submission of sbla to fda, application for a variation to marketing authorization to ema for xgeva.  Full Article

More From Around the Web

BRIEF-Amgen's multiple Myeloma treatment in combination with Dexamethasone, receives NICE recommendation for use at first relapse

* Amgen's multiple Myeloma treatment, Kyprolis® (Carfilzomib), in combination with Dexamethasone, receives NICE recommendation for use at first relapse