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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 Announces Top-Line Results From Phase 3 Study Of Abp 710, Biosimilar Candidate To Infliximab
Wednesday, 27 Jun 2018 09:00am EDT 

June 27 (Reuters) - Amgen Inc ::AMGEN ANNOUNCES TOP-LINE RESULTS FROM PHASE 3 STUDY OF ABP 710, BIOSIMILAR CANDIDATE TO INFLIXIMAB.AMGEN INC - RESULTS CONFIRM NON-INFERIORITY COMPARED TO INFLIXIMAB BUT COULD NOT RULE OUT SUPERIORITY BASED ON ITS PRIMARY EFFICACY ENDPOINT.AMGEN - RESULTS FROM STUDY CONFIRM NON-INFERIORITY COMPARED TO INFLIXIMAB BUT COULD NOT RULE OUT SUPERIORITY BASED ON ITS PRIMARY EFFICACY ENDPOINT.AMGEN - PRIMARY ENDPOINT OF ACR20 HAD PRESPECIFIED EQUIVALENCE MARGIN OF +/- 15 PERCENT , AND OBSERVED UPPER END OF CONFIDENCE INTERVAL WAS 15.96 PERCENT.AMGEN INC - ACR50 AND ACR70 TRENDED IN SAME DIRECTION AS ACR20.AMGEN INC - OVERALL, SAFETY PROFILE AND IMMUNOGENICITY WERE COMPARABLE BETWEEN ABP 710 AND INFLIXIMAB.  Full Article

Health Canada Approves Amgen's Repatha To Reduce Risk Of Cardiovascular Events
Tuesday, 19 Jun 2018 08:00am EDT 

June 19 (Reuters) - Amgen Inc ::HEALTH CANADA APPROVES AMGEN'S REPATHA® (EVOLOCUMAB) TO REDUCE RISK OF CARDIOVASCULAR EVENTS IN ADULTS WITH ATHEROSCLEROTIC CARDIOVASCULAR DISEASE.  Full Article

FDA Approves Addition Of Survival Data From Phase 3 Aspire Trial To Kyprolis Label
Monday, 11 Jun 2018 09:00am EDT 

June 11 (Reuters) - Amgen Inc ::FDA APPROVES ADDITION OF POSITIVE OVERALL SURVIVAL DATA FROM PHASE 3 ASPIRE TRIAL TO KYPROLIS® (CARFILZOMIB) LABEL.AMGEN INC - SAFETY DATA WERE CONSISTENT WITH KNOWN SAFETY PROFILE OF KYPROLIS.AMGEN INC - KYPROLIS, LENALIDOMIDE AND DEXAMETHASONE EXTENDED MEDIAN OVERALL SURVIVAL IN RELAPSED OR REFRACTORY MULTIPLE MYELOMA PATIENTS TO 48 MONTHS.  Full Article

FDA Approves Prolia For Glucocorticoid-Induced Osteoporosis
Monday, 21 May 2018 04:00pm EDT 

May 21 (Reuters) - Amgen Inc ::FDA APPROVES PROLIA® (DENOSUMAB) FOR GLUCOCORTICOID-INDUCED OSTEOPOROSIS.FDA APPROVES PROLIA® (DENOSUMAB) FOR GLUCOCORTICOID-INDUCED OSTEOPOROSIS.AMGEN INC - SAFETY RESULTS WERE CONSISTENT WITH KNOWN SAFETY PROFILE OF PROLIA.AMGEN INC - APPROVAL OF PROLIA FOR GLUCOCORTICOID-INDUCED OSTEOPOROSIS IS BASED ON DATA FROM A PHASE 3 STUDY.  Full Article

Novartis, Amgen Announce FDA Approval Of Aimovig Treatment For Migraine Prevention
Thursday, 17 May 2018 07:11pm EDT 

May 17 (Reuters) - Novartis Ag ::NOVARTIS AND AMGEN ANNOUNCE FDA APPROVAL OF AIMOVIG™ (ERENUMAB-AOOE), A NOVEL TREATMENT DEVELOPED SPECIFICALLY FOR MIGRAINE PREVENTION.EMA MARKETING AUTHORIZATION APPLICATION FOR AIMOVIG IS UNDER REVIEW. NOVARTIS EXPECTS APPROVAL IN EU IN COMING MONTHS.  Full Article

Amgen Says FDA Approves Aimovig, A Treatment For Migraine Prevention
Thursday, 17 May 2018 07:04pm EDT 

May 17 (Reuters) - Amgen Inc ::FDA APPROVES AIMOVIG™ (ERENUMAB-AOOE), A NOVEL TREATMENT DEVELOPED SPECIFICALLY FOR MIGRAINE PREVENTION.AIMOVIG IS EXPECTED TO BE AVAILABLE TO PATIENTS WITHIN ONE WEEK.  Full Article

Amgen Plans To Build A New Biomanufacturing Plant in Rhode Island
Tuesday, 10 Apr 2018 12:07pm EDT 

April 10 (Reuters) - Amgen Inc ::AMGEN ANNOUNCES RHODE ISLAND WILL BE LOCATION OF FIRST US NEXT-GENERATION BIOMANUFACTURING PLANT.FOLLOWING RECENT U.S. FEDERAL TAX REFORM, CO MADE DECISION TO LOCATE NEW PLANT IN U.S. RHODE ISLAND.  Full Article

EU Medicines Agency Recommends Approval Of Amgen Europe, Sandoz Biosimilar Drugs
Friday, 23 Mar 2018 08:57am EDT 

March 23 (Reuters) - EU Medicines Agency: :EU MEDICINES AGENCY RECOMMENDS APPROVAL OF AMGEN EUROPE'S BIOSIMILAR DRUG FOR TREATMENT OF BREAST AND GASTRIC CANCER.EU MEDICINES AGENCY RECOMMENDS APPROVAL OF SANDOZ'S BIOSIMILAR DRUG FOR TREATMENT OF RHEUMATOID ARTHRITIS, CROHN'S DISEASE, ULCERATIVE COLITIS, ETC. .  Full Article

CHMP Recognizes That Amgen's Repatha Prevents Heart Attacks And Strokes
Friday, 23 Mar 2018 08:44am EDT 

March 23 (Reuters) - Amgen Inc ::AMGEN RECEIVES POSITIVE CHMP OPINION RECOGNIZING THAT REPATHA (EVOLOCUMAB) PREVENTS HEART ATTACKS AND STROKES.AMGEN INC - RECOMMENDED LABEL INCLUDES NEW INDICATION BASED ON REPATHA CARDIOVASCULAR OUTCOMES STUDY.  Full Article

Amgen And Allergan Receive Positive CHMP Opinion For Abp 980
Friday, 23 Mar 2018 08:41am EDT 

March 23 (Reuters) - Allergan Plc ::AMGEN AND ALLERGAN RECEIVE POSITIVE CHMP OPINION FOR ABP 980 (BIOSIMILAR HERCEPTIN®) FOR THE TREATMENT OF THREE TYPES OF CANCER.AMGEN ‍RECOMMENDED FOR APPROVAL FOR SAME INDICATIONS AS HERCEPTIN​.AMGEN CHMP POSITIVE OPINION FOR ABP 980 WILL NOW BE REVIEWED BY EUROPEAN COMMISSION.  Full Article

UPDATE 1-AstraZeneca gets FDA breakthrough therapy label for asthma treatment

Sept 7 AstraZeneca Plc and Amgen Inc said on Friday the U.S. Food and Drug Administration had granted a breakthrough therapy label for their drug to treat a type of severe asthma, potentially speeding up its development and regulatory review.