Edition:
United States

Amgen Inc (AMGN.OQ)

AMGN.OQ on NASDAQ Stock Exchange Global Select Market

180.21USD
21 Jul 2017
Change (% chg)

$0.89 (+0.50%)
Prev Close
$179.32
Open
$179.26
Day's High
$180.55
Day's Low
$179.19
Volume
1,182,717
Avg. Vol
1,300,357
52-wk High
$184.20
52-wk Low
$133.64

Latest Key Developments (Source: Significant Developments)

Amgen says FDA accepts biologics license application for Aimovig
Thursday, 20 Jul 2017 04:30pm EDT 

July 20 (Reuters) - Amgen Inc :FDA accepts biologics license application for Aimovig™ (erenumab).Amgen Inc - FDA has set a prescription drug user fee act (PDUFA) target action date of May 17, 2018..Amgen Inc - Aimovig will be jointly commercialized in U.S. by Amgen and Novartis..  Full Article

Amgen and Array BioPharma announce preclinical license and collaboration agreement
Tuesday, 18 Jul 2017 08:00am EDT 

July 18 (Reuters) - Array BioPharma Inc :Amgen and Array BioPharma announce preclinical license and collaboration agreement in inflammation.Array BioPharma - under terms of agreement, Amgen and Array will collaborate on preclinical development with Array leading medicinal chemistry work.Array BioPharma Inc - ‍Amgen is responsible for clinical development and commercialization​.Array BioPharma - in exchange for exclusive rights to Array's preclinical program, Amgen will make upfront and milestone payments.Array BioPharma - Amgen will also pay royalties on sales of resulting therapies.  Full Article

Amgen submits regulatory applications in US, Europe
Friday, 14 Jul 2017 09:00am EDT 

July 14 (Reuters) - Amgen Inc ::Amgen submits regulatory applications in US and Europe to include overall survival data in kyprolis (carfilzomib) label.Amgen - data showed kyprolis and dexamethasone reduced risk of death by 21 percent and increased overall survival by 7.6 months versus velcade and dexamethasone​.Amgen - ‍announced variation to marketing application to EMA to include OS data from phase 3 head-to-head endeavor trial in product info for kyprolis​.Says ‍adverse events observed in this updated analysis were consistent with those previously reported for endeavor​.Amgen - submission of SNDA to FDA, variation to marketing application to EMA to include overall survival data from phase 3 kyprolis​ trial.  Full Article

Amgen, Allergan to discuss data supporting biologics license application for ABP 215
Thursday, 13 Jul 2017 08:00am EDT 

July 13 (Reuters) - Allergan Plc :Amgen and allergan to discuss data supporting biologics license application for abp 215, a biosimilar candidate to avastin® (bevacizumab).Amgen inc- ‍fda has set a biosimilar user fee act (bsufa) target action date of sept. 14, 2017, for abp 215​.Amgen inc- ‍co, allergan will discuss data supporting abp 215 bla with oncologic drugs advisory committee of u.s. fda​.  Full Article

Amgen says FDA grants full approval for Blincyto to treat relapsed or refractory b-cell precursor acute lymphoblastic leukemia
Tuesday, 11 Jul 2017 07:22pm EDT 

July 11 (Reuters) - Amgen Inc :FDA grants full approval for blincyto® (blinatumomab) to treat relapsed or refractory b-cell precursor acute lymphoblastic leukemia in adults and children.Amgen Inc - u.s. Fda approved supplemental biologics license application for blincytoto include overall survival data from phase 3 tower study.Approval converts blincyto's accelerated approval to a full approval.  Full Article

FDA approves Vectibix for use in wild-type RAS metastatic colorectal cancer
Thursday, 29 Jun 2017 05:30pm EDT 

June 29 (Reuters) - Amgen Inc ::FDA approves Vectibix® (panitumumab) for use in wild-type RAS metastatic colorectal cancer.Amgen Inc - ‍U.S. Fda approved supplemental biologics license application for vectibix for patients with wild-type RAS metastatic colorectal cancer​.  Full Article

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

BRIEF-Amgen says FDA accepts biologics license application for Aimovig

* FDA accepts biologics license application for Aimovig™ (erenumab)