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Astellas Pharma Inc (4503.T)

4503.T on Tokyo Stock Exchange

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Latest Key Developments (Source: Significant Developments)

Pfizer Says Xtandi (Enzalutamide) Plus Androgen Deprivation Therapy (Adt) Met Primary Endpoint
Monday, 11 Feb 2019 05:00pm EST 

Feb 11 (Reuters) - Astellas Pharma Inc <4503.T>::PHASE 3 ARCHES TRIAL SHOWS XTANDI® (ENZALUTAMIDE) SIGNIFICANTLY IMPROVED RADIOGRAPHIC PROGRESSION-FREE SURVIVAL IN MEN WITH METASTATIC HORMONE-SENSITIVE PROSTATE CANCER.PFIZER INC - XTANDI (ENZALUTAMIDE) PLUS ANDROGEN DEPRIVATION THERAPY (ADT) MET PRIMARY ENDPOINT.PFIZER INC - SECONDARY ENDPOINTS REPORTED SHOWED THAT XTANDI PLUS ADT REDUCED RISK OF PSA PROGRESSION.PFIZER INC - SECONDARY ENDPOINTS REPORTED SHOWED THAT XTANDI PLUS ADT REDUCED RISK OF STARTING A NEW ANTINEOPLASTIC THERAPY COMPARED TO ADT ALONE.  Full Article

Astellas Pharma Canada Says Health Canada Approved Expanded Indication For Xtandi
Monday, 14 Jan 2019 08:00am EST 

Jan 14 (Reuters) - Astellas Pharma Inc <4503.T>::ASTELLAS PHARMA CANADA - HEALTH CANADA APPROVED EXPANDED INDICATION FOR XTANDI (ENZALUTAMIDE), FOR TREATMENT OF PATIENTS WITH PROSTATE CANCER.ASTELLAS PHARMA CANADA - XTANDI (ENZALUTAMIDE) IS NOW INDICATED TO TREAT MEN WITH NON-METASTATIC CASTRATION-RESISTANT PROSTATE CANCER.  Full Article

Amgen Inc - Evenity Receives Approval In Japan For Treatment Of Osteoporosis
Tuesday, 8 Jan 2019 04:00pm EST 

Jan 8 (Reuters) - Amgen Inc ::EVENITY(ROMOSOZUMAB) RECEIVES APPROVAL IN JAPAN FOR THE TREATMENT OF OSTEOPOROSIS IN PATIENTS AT HIGH RISK OF FRACTURE.AMGEN INC - EVENITY IN JAPAN IS BEING CO-DEVELOPED THROUGH STRATEGIC ALLIANCE WITH AMGEN ASTELLAS BIOPHARMA.AMGEN INC - JAPANESE MINISTRY OF HEALTH, LABOR AND WELFARE HAS GRANTED A MARKETING AUTHORIZATION FOR EVENITY.  Full Article

Fibrogen Inc - Co and Astellas Pharma Inc entered into an amendment to collaboration agreement - SEC Filing
Friday, 7 Dec 2018 05:22pm EST 

Dec 7 (Reuters) - Astellas Pharma Inc <4503.T>::FIBROGEN INC SAYS ON NOV 30, CO AND ASTELLAS PHARMA INC. ENTERED INTO AN AMENDMENT TO COLLABORATION AGREEMENT DATED AS OF JUNE 1, 2005 - SEC FILING.FIBROGEN INC - UNDER THIS AMENDMENT, FIBROGEN WOULD CONTINUE TO MANUFACTURE AND DELIVER TO ASTELLAS ROXADUSTAT ACTIVE PHARMACEUTICAL INGREDIENT.FIBROGEN INC - AMENDMENT OBLIGATES ASTELLAS TO PURCHASE A TOTAL OF NET $62.7 MILLION OF ROXADUSTAT ACTIVE PHARMACEUTICAL INGREDIENT.  Full Article

Merchavia's Portfolio Company 'Juventas' Announces Strategic Commercialization Agreement
Monday, 3 Dec 2018 08:00am EST 

Dec 3 (Reuters) - Merchavia Holdings and Investments Ltd ::MERCHAVIA'S PORTFOLIO COMPANY 'JUVENTAS' ANNOUNCES STRATEGIC COMMERCIALIZATION AGREEMENT.MERCHAVIA HOLDINGS AND INVESTMENTS - AGREEMENT GRANTS ASTELLAS AN RESEARCH AND DEVELOPMENT LICENSE TO CONDUCT ON JVS-100 CANDIDATE, THROUGH PHASE IIA CLINICAL TRIALS.MERCHAVIA HOLDINGS AND INVESTMENTS - AGREEMENT ALSO GRANTS ASTELLAS OPTION TO ACQUIRE JVS-100 FROM JUVENTAS, FOR DEVELOPMENT & COMMERCIALIZATION.MERCHAVIA - UNDER TERMS, ASTELLAS WILL RECEIVE LICENSE FOR RESEARCH AND DEVELOPMENT STAGES OF FUTURE CLINICAL TRIALS, FROM IIA STAGE, INCLUDING FULL FINANCING.  Full Article

Astellas Pharma completes share repurchase
Friday, 21 Sep 2018 02:39am EDT 

Sept 21(Reuters) - Astellas Pharma Inc <4503.T>:Says it completes repurchase of 55.5 million shares of its common stock.Shares repurchased at the price of 100 billion yen in total, during period from June 1 to Sept. 20 .  Full Article

Pfizer And Astellas Amend Clinical Research Protocols For Two Phase 3 Trials Of Enzalutamide
Wednesday, 22 Aug 2018 05:00pm EDT 

Aug 22 (Reuters) - Astellas Pharma Inc <4503.T>::PFIZER AND ASTELLAS AMEND CLINICAL RESEARCH PROTOCOLS FOR TWO PHASE 3 TRIALS OF ENZALUTAMIDE IN PATIENTS WITH HORMONE-SENSITIVE PROSTATE CANCER.PFIZER INC - AMENDMENTS ACCELERATE ANTICIPATED PRIMARY COMPLETION DATES FOR BOTH ARCHES AND EMBARK TRIALS.PFIZER INC - AMENDMENTS TO PROTOCOLS FOR TWO REGISTRATIONAL PHASE 3 TRIALS, ARCHES AND EMBARK.PFIZER INC - CHANGES TO PROTOCOL FOR PHASE 3 ARCHES STUDY INCLUDE REVISION OF PLANNED ANALYSES OF PRIMARY AND SECONDARY ENDPOINTS.PFIZER INC - COS ANTICIPATE PRIMARY COMPLETION DATE FOR ARCHES CLINICAL TRIAL TO BE IN LATE 2018.PFIZER INC - ESTIMATED PRIMARY COMPLETION DATE FOR EMBARK CLINICAL TRIAL IS MID-2020.PFIZER INC - REVISIONS WERE ALSO MADE TO PROTOCOL FOR PHASE 3 EMBARK STUDY.PFIZER - MAIN PURPOSE OF AMENDMENT TO PROTOCOL FOR PHASE 3 EMBARK STUDY IS TO REVISE THE PLANNED ANALYSES OF THE PRIMARY & SEVERAL SECONDARY ENDPOINTS.  Full Article

Astellas Says To Cut 600 Jobs Via Early Retirement Programme As Part Of Japan Operations Restructuring
Monday, 21 May 2018 11:09pm EDT 

May 22 (Reuters) - Astellas Pharma Inc <4503.T>::ASTELLAS SAYS TO CUT 600 JOBS VIA EARLY RETIREMENT PROGRAMME AS PART OF JAPAN OPERATIONS RESTRUCTURING.  Full Article

Astellas Pharma to retire treasury shares
Wednesday, 25 Apr 2018 11:06pm EDT 

April 26 (Reuters) - Astellas Pharma Inc <4503.T>:Says it will retire 89 million shares(4.3 percent stake) of its common stock on May 31 .Says the total shares outstanding is 1.98 billion shares after the retirement .  Full Article

U.S. FDA Grants Priority Review For Supplemental New Drug Application For Xtandi
Monday, 19 Mar 2018 04:15pm EDT 

March 19 (Reuters) - Astellas Pharma Inc <4503.T>::U.S. FDA GRANTS PRIORITY REVIEW FOR A SUPPLEMENTAL NEW DRUG APPLICATION (SNDA) FOR XTANDI® (ENZALUTAMIDE) IN NON-METASTATIC CASTRATION-RESISTANT PROSTATE CANCER (CRPC).ASTELLAS PHARMA INC - ‍PRESCRIPTION DRUG USER FEE ACT (PDUFA) GOAL DATE ASSIGNED BY FDA IS JULY 2018​.  Full Article

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Drugmakers Astellas, Amgen to pay $125 million in U.S. charity kickback probe

BOSTON Two drugmakers will pay nearly $125 million to resolve claims they used charities that help cover Medicare patients' out-of-pocket drug costs as a way to pay kickbacks aimed at encouraging the use of their high-priced medications, the U.S. Justice Department said on Thursday.