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Amgen Inc (AMGN.OQ)

AMGN.OQ on NASDAQ Stock Exchange Global Select Market

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16 Jan 2019
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Latest Key Developments (Source: Significant Developments)

BRIEF-Teva And Amgen Resolve Ongoing Dispute Over Teva's Generic Cinacalcet HCl Product
Thursday, 3 Jan 2019 

Corrects spelling of drug in headline and first bullet:TEVA AND AMGEN RESOLVE ONGOING DISPUTE OVER TEVA'S GENERIC CINACALCET HCL PRODUCT.TEVA WILL PAY AMGEN AN UNDISCLOSED AMOUNT AS PART OF THE SETTLEMENT.THE AMOUNT AND OTHER TERMS OF SETTLEMENT REMAIN CONFIDENTIAL.TEVA PHARMACEUTICAL INDUSTRIES- LITIGATION BETWEEN PARTIES TO BE ENDED.TEVA PHARMACEUTICAL INDUSTRIES- CO AGREED TO STOP SELLING ITS GENERIC PRODUCT UNTIL LICENSE DATE IN MID 2021, OR EARLIER UNDER CERTAIN CIRCUMSTANCES.  Full Article

Amgen And Molecular Partners Announce Strategic Collaboration In Immuno-Oncology
Wednesday, 19 Dec 2018 

Dec 18 (Reuters) - :AMGEN AND MOLECULAR PARTNERS ANNOUNCE STRATEGIC COLLABORATION IN IMMUNO-ONCOLOGY.AMGEN-AMGEN AND MOLECULAR PARTNERS ANNOUNCE STRATEGIC COLLABORATION IN IMMUNO-ONCOLOGY.AMGEN-MOLECULAR PARTNERS WILL RECEIVE UPFRONT PAYMENT OF $50 MILLION.AMGEN-PARTIES WILL SHARE CLINICAL DEVELOPMENT COSTS IN DEFINED PERCENTAGES FOR FIRST THREE INDICATIONS SUBJECT TO CERTAIN CONDITIONS.AMGEN-FOR ALL ADDITIONAL CLINICAL TRIALS, AMGEN IS RESPONSIBLE FOR ALL DEVELOPMENT COSTS.AMGEN - MOLECULAR PARTNERS ELIGIBLE TO RECEIVE UP TO $497 MILLION IN DEVELOPMENT, REGULATORY AND COMMERCIAL MILESTONE PAYMENTS.AMGEN - PARTIES WILL JOINTLY EVALUATE MP0310 IN COMBINATION WITH AMGEN'S ONCOLOGY PIPELINE PRODUCTS.AMGEN-ANTICIPATE MP0310 TO ENTER CLINIC IN 2019.  Full Article

Amgen Submits Biologics License Application For ABP 710 (Biosimilar Infliximab) To US Food And Drug Administration
Monday, 17 Dec 2018 

Dec 17 (Reuters) - Amgen Inc ::AMGEN SUBMITS BIOLOGICS LICENSE APPLICATION FOR ABP 710 (BIOSIMILAR INFLIXIMAB) TO US FOOD AND DRUG ADMINISTRATION.AMGEN - BLA FOR ABP 710 SUPPORTED BY PHASE 3 STUDY IN PATIENTS WITH MODERATE-TO-SEVERE RHEUMATOID ARTHRITIS.  Full Article

FDA Says Approves Romiplostim For Pediatric Patients With ITP
Friday, 14 Dec 2018 

Dec 14 (Reuters) - U.S. Food And Drug Administration::FDA - APPROVES AMGEN'S ROMIPLOSTIM FOR PEDIATRIC PATIENTS WITH IMMUNE THROMBOCYTOPENIA.FDA - APPROVES ROMIPLOSTIM FOR PEDIATRIC PATIENTS WITH ITP FOR AT LEAST 6 MONTHS WHO'VE HAD INSUFFICIENT RESPONSE TO CORTICOSTEROIDS, IMMUNOGLOBULINS.  Full Article

Advaxis - On Dec 10 Co Received Written Notice Of Termination From Amgen With Respect To License & Collaboration Agreement, Dated As Of Aug 1, 2016
Thursday, 13 Dec 2018 

Dec 13 (Reuters) - Advaxis Inc ::ADVAXIS - ON DEC 10 CO RECEIVED WRITTEN NOTICE OF TERMINATION FROM AMGEN WITH RESPECT TO LICENSE & COLLABORATION AGREEMENT, DATED AS OF AUG 1, 2016.ADVAXIS INC - TERMINATION OF AGREEMENT IS EFFECTIVE AS OF FEBRUARY 8, 2019 - SEC FILING.ADVAXIS INC - AGREEMENT IS PERTAINING TO DEVELOPMENT AND COMMERCIALIZATION OF CO'S ADXS-NEO PROGRAM.ADVAXIS - CO'S ADXS-NEO STUDY IS CURRENTLY ENROLLING PATIENTS AND CO WILL EVALUATE WHETHER TO RE-PARTNER ADXS-NEO PROGRAM.ADVAXIS -UPON TERMINATION, LICENSE TO AMGEN TO TERMINATE & CO TO REGAIN WORLDWIDE RIGHTS FOR DEVELOPMENT & COMMERCIALIZATION OF ADXS-NEO PROGRAM.  Full Article

Amgen And Magellan Rx Management Collaborate To Improve Patient Care For Chronic, Difficult-To-Treat Conditions
Tuesday, 11 Dec 2018 

Dec 11 (Reuters) - Amgen Inc ::AMGEN AND MAGELLAN RX MANAGEMENT COLLABORATE TO IMPROVE PATIENT CARE FOR CHRONIC, DIFFICULT-TO-TREAT CONDITIONS.AMGEN INC - ANNOUNCED MULTI-YEAR COLLABORATION WITH MAGELLAN RX MANAGEMENT, PHARMACY BENEFIT MANAGEMENT DIVISION OF MAGELLAN HEALTH.  Full Article

Entera Bio, Amgen Enter Collaboration In Inflammatory Disease, Other Illnesses
Tuesday, 11 Dec 2018 

Dec 11 (Reuters) - Entera Bio Ltd ::ENTERA BIO AND AMGEN ENTER STRATEGIC RESEARCH COLLABORATION IN INFLAMMATORY DISEASE AND OTHER SERIOUS ILLNESSES.ENTERA BIO - UNDER DEAL, CO TO BE ELIGIBLE TO RECEIVE UP TO $270 MILLION IN CLINICAL & COMMERCIAL MILESTONE PAYMENTS.ENTERA BIO - AMGEN WILL HAVE OPTION TO ADVANCE UP TO 3 LARGE MOLECULE PROGRAMS USING ENTERA’S ORAL DELIVERY TECHNOLOGY.ENTERA BIO - UNDER DEAL, CO TO RECEIVE INITIAL TECHNOLOGY ACCESS FEE FROM AMGEN & WILL BE RESPONSIBLE FOR PRECLINICAL DEVELOPMENT AT AMGEN’S EXPENSE.ENTERA BIO - UNDER DEAL, AMGEN IS RESPONSIBLE FOR CLINICAL DEVELOPMENT, MANUFACTURING & COMMERCIALIZATION OF ANY OF RESULTING PROGRAMS.ENTERA BIO - UNDER DEAL, CO WILL RETAIN ALL INTELLECTUAL PROPERTY RIGHTS TO ITS DRUG DELIVERY TECHNOLOGY.ENTERA BIO - AMGEN WILL RETAIN ALL RIGHTS TO ITS LARGE MOLECULES AND ANY SUBSEQUENT IMPROVEMENTS.  Full Article

Amgen Sets Quarterly Dividend Of $1.32/Share
Tuesday, 23 Oct 2018 

Oct 23 (Reuters) - Amgen Inc ::SETS QUARTERLY DIVIDEND OF $1.32PER SHARE.  Full Article

FDA Approves KYPROLIS Once-Weekly 70 mg/m2 In Combination With Dexamethasone
Monday, 1 Oct 2018 

Oct 1 (Reuters) - Amgen Inc ::FDA APPROVES KYPROLIS® (CARFILZOMIB) ONCE-WEEKLY 70 MG/M2 IN COMBINATION WITH DEXAMETHASONE (KD70) FOR PATIENTS WITH RELAPSED OR REFRACTORY MULTIPLE MYELOMA.AMGEN INC - APPLICATION REVIEWED AND APPROVED UNDER FDA'S REAL-TIME ONCOLOGY REVIEW AND ASSESSMENT AID PILOT PROGRAMS.AMGEN INC - APPROVAL OF A MORE CONVENIENT ONCE-WEEKLY KD70 REGIMEN BASED ON DATA FROM PHASE 3 HEAD-TO-HEAD A.R.R.O.W. STUDY.AMGEN INC - OVERALL SAFETY PROFILES OF TWO ARMS IN A.R.R.O.W. WERE COMPARABLE, WITH NO NEW SAFETY RISKS IDENTIFIED IN ONCE-WEEKLY ARM.AMGEN INC - KYPROLIS IS NOT APPROVED FOR TWICE-WEEKLY 27 MG/M(2) ADMINISTRATION IN COMBINATION WITH DEXAMETHASONE ALONE..AMGEN INC - FDA APPROVED SNDA TO EXPAND PRESCRIBING INFORMATION FOR KYPROLIS TO INCLUDE A ONCE-WEEKLY DOSING OPTION IN COMBINATION WITH DEXAMETHASONE.  Full Article

Astrazeneca Says Tezepelumab Gets FDA Breakthrough Therapy Status
Friday, 7 Sep 2018 

Sept 7 (Reuters) - AstraZeneca Plc ::TEZEPELUMAB FDA BREAKTHROUGH THERAPY DESIGNATION.TEZEPELUMAB GRANTED BREAKTHROUGH THERAPY DESIGNATION BY US FDA.ASTRAZENECA'S FIRST BREAKTHROUGH THERAPY DESIGNATION FOR A RESPIRATORY MEDICINE.  Full Article

UPDATE 2-Amgen's postmenopausal osteoporosis drug wins FDA panel backing

Jan 16 An advisory panel to the U.S. Food and Drug Administration said on Wednesday that benefits of Amgen Inc's osteoporosis treatment for postmenopausal women at high risk for fracture outweighed its risks and overwhelmingly voted for the drug's approval.