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Amgen Inc (AMGN.OQ)

AMGN.OQ on NASDAQ Stock Exchange Global Select Market

202.34USD
18 Sep 2018
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Latest Key Developments (Source: Significant Developments)

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

Tezepelumab Granted Breakthrough Therapy Designation By US FDA
Friday, 7 Sep 2018 

Sept 7 (Reuters) - Amgen Inc ::TEZEPELUMAB GRANTED BREAKTHROUGH THERAPY DESIGNATION BY US FDA FOR THE TREATMENT OF PATIENTS WITH SEVERE ASTHMA WITHOUT AN EOSINOPHILIC PHENOTYPE.TEZEPELUMAB IS CURRENTLY IN DEVELOPMENT IN PHASE 3 PATHFINDER CLINICAL TRIAL PROGRAM.  Full Article

Amegen - European Commission Approves Blincyto
Wednesday, 29 Aug 2018 

Aug 29 (Reuters) - Amgen Inc ::EUROPEAN COMMISSION APPROVES BLINCYTO® (BLINATUMOMAB) FOR USE IN PEDIATRIC PATIENTS WITH PHILADELPHIA CHROMOSOME-NEGATIVE RELAPSED OR REFRACTORY B-CELL PRECURSOR ACUTE LYMPHOBLASTIC LEUKEMIA.AMGEN - APPROVAL IS BASED ON RESULTS FROM PHASE 1/2 '205 STUDY,OPEN-LABEL, MULTICENTER, SINGLE-ARM TRIAL WHICH EVALUATED EFFICACY & SAFETY OF BLINCYTO.  Full Article

Amgen Submits Supplemental New Drug Application For Kyprolis
Monday, 27 Aug 2018 

Aug 27 (Reuters) - Amgen Inc ::AMGEN SUBMITS SUPPLEMENTAL NEW DRUG APPLICATION FOR KYPROLIS® (CARFILZOMIB) ONCE-WEEKLY 70 MG/M2 IN COMBINATION WITH DEXAMETHASONE.AMGEN INC - FDA REVIEWING APPLICATION UNDER ONCOLOGY CENTER OF EXCELLENCE REAL-TIME ONCOLOGY REVIEW AND ASSESSMENT AID PILOT PROGRAMS.  Full Article

Arrowhead Pharmaceuticals Earns $10 Mln Milestone Payment From Amgen
Wednesday, 1 Aug 2018 

Aug 1 (Reuters) - Arrowhead Pharmaceuticals Inc ::ARROWHEAD PHARMACEUTICALS SAYS EARNED $10 MILLION MILESTONE PAYMENT FROM AMGEN FOLLOWING ADMINISTRATION OF FIRST DOSE OF AMG 890.  Full Article

Amgen Sets Quarterly Dividend Of $1.32/Share
Tuesday, 31 Jul 2018 

July 31 (Reuters) - Amgen Inc ::AMGEN ANNOUNCES 2018 THIRD QUARTER DIVIDEND.SETS QUARTERLY DIVIDEND OF $1.32PER SHARE.  Full Article

Amgen Reports Qtrly Adjusted Earnings Per Share $3.83
Thursday, 26 Jul 2018 

July 26 (Reuters) - Amgen Inc ::AMGEN QTRLY EARNINGS PER SHARE $3.48; QTRLY ADJUSTED EARNINGS PER SHARE $3.83; QTRLY REVENUE $6.06 BILLION, UP 4 PERCENT.AMGEN SEES 2018 EARNINGS PER SHARE $11.83 - $12.62; SEES 2018 ADJUSTED EARNINGS PER SHARE $13.30 - $14.00; SEES 2018 REVENUE $22.5 BILLION - $23.2 BILLION.AMGEN SEES 2018 CAPEX TO BE ABOUT $750 MILLION.Q2 EARNINGS PER SHARE VIEW $3.54, REVENUE VIEW $5.73 BILLION -- THOMSON REUTERS I/B/E/S.FY2018 EARNINGS PER SHARE VIEW $13.75, REVENUE VIEW $22.59 BILLION -- THOMSON REUTERS I/B/E/S.  Full Article

Amgen, UCB Resubmit Biologics License Application For Evenity To U.S. FDA
Friday, 13 Jul 2018 

July 13 (Reuters) - AMGEN INC ::AMGEN AND UCB RESUBMIT BIOLOGICS LICENSE APPLICATION (BLA) FOR EVENITY™ (ROMOSOZUMAB) TO THE US FDA.  Full Article

Novartis Presents New Data Demonstrating Long-Term Efficacy Of Aimovig
Thursday, 28 Jun 2018 

June 28 (Reuters) - Novartis AG ::NOVARTIS PRESENTS NEW DATA DEMONSTRATING LONG-TERM EFFICACY, SAFETY AND TOLERABILITY OF AIMOVIG® (ERENUMAB) IN PATIENTS WITH CHRONIC AND EPISODIC MIGRAINE.NOVARTIS AG -SAFETY RESULTS AFTER ONE YEAR WERE CONSISTENT WITH ESTABLISHED SAFETY PROFILE OF AIMOVIG IN PREVIOUS STUDIES..NOVARTIS - AIMOVIG SHOWED ROBUST EFFICACY IN PATIENTS WITH CHRONIC MIGRAINE, WITH SUBSTANTIAL REDUCTIONS IN MONTHLY MIGRAINE DAYS SUSTAINED THROUGHOUT.  Full Article

Amgen And Novartis Present New Data Demonstrating Long-Term Efficacy, Safety And Tolerability Of Aimovig™
Thursday, 28 Jun 2018 

June 28 (Reuters) - Amgen Inc ::AMGEN AND NOVARTIS PRESENT NEW DATA DEMONSTRATING LONG-TERM EFFICACY, SAFETY AND TOLERABILITY OF AIMOVIG™ (ERENUMAB-AOOE) IN PATIENTS WITH CHRONIC AND EPISODIC MIGRAINE.AMGEN - RESULTS FROM A ONE-YEAR STUDY IN CHRONIC MIGRAINE PATIENTS "REINFORCED" ESTABLISHED SAFETY AND EFFICACY PROFILE OF AIMOVIG IN LONG-TERM USE.AMGEN INC - SAFETY RESULTS OF STUDY AFTER ONE YEAR WERE CONSISTENT WITH ESTABLISHED SAFETY PROFILE OF AIMOVIG IN PREVIOUS STUDIES.AMGEN INC - EFFICACY DATA OF STUDY SHOWED SUSTAINED BENEFITS UP TO ONE YEAR.AMGEN INC - AIMOVIG STUDY IS CONTINUING FOR UP TO FIVE YEARS OF TREATMENT.  Full Article

UPDATE 2-U.S. regulator approves Teva migraine drug, shares rise

Sept 14 Shares of Israeli drugmaker Teva Pharmaceutical Industries rose over 5 percent in after-hours trading on Friday after the U.S. Food and Drug Administration (FDA) approved the company's new migraine treatment, a drug Teva has been banking on to help revive its fortunes.