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Astellas Pharma Inc (4503.T)

4503.T on Tokyo Stock Exchange

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29 Oct 2020
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Latest Key Developments (Source: Significant Developments)

Astellas Pharma Completes Acquisition Of Iota Biosciences
Friday, 30 Oct 2020 

Oct 30 (Reuters) - Astellas Pharma Inc <4503.T>::COMPLETES ACQUISITION OF IOTA BIOSCIENCES.  Full Article

Astellas Receives U.S. FDA Fast Track Designation For ASP5354, An Investigational Near-Infrared Fluorescence Imaging Agent
Wednesday, 28 Oct 2020 

Oct 28 (Reuters) - Astellas Pharma Inc <4503.T>::ASTELLAS RECEIVES U.S. FDA FAST TRACK DESIGNATION FOR ASP5354, AN INVESTIGATIONAL NEAR-INFRARED FLUORESCENCE IMAGING AGENT.ASTELLAS PHARMA - ASP5354 FAST TRACK DESIGNATION EXPECTED TO FACILITATE DEVELOPMENT, POTENTIALLY EARLY CLINICAL AVAILABILITY.  Full Article

Seagen And Astellas Announce Positive Topline Results From Phase 2 Pivotal Trial Of Padcev
Monday, 12 Oct 2020 

Oct 12 (Reuters) - Astellas Pharma Inc <4503.T>::SEAGEN AND ASTELLAS ANNOUNCE POSITIVE TOPLINE RESULTS FROM SECOND COHORT OF PATIENTS IN PHASE 2 PIVOTAL TRIAL OF PADCEV® (ENFORTUMAB VEDOTIN-EJFV) IN ADVANCED UROTHELIAL CANCER.SEAGEN AND ASTELLAS ANNOUNCE POSITIVE TOPLINE RESULTS FROM SECOND COHORT OF PATIENTS IN PHASE 2 PIVOTAL TRIAL OF PADCEV® (ENFORTUMAB VEDOTIN-EJFV) IN ADVANCED UROTHELIAL CANCER.ASTELLAS - DURABLE RESPONSES OBSERVED IN PATIENTS WHO GOT IMMUNOTHERAPY BUT WERE INELIGIBLE FOR CISPLATIN IN LOCALLY ADVANCED/METASTATIC SETTING.ASTELLAS PHARMA - RESULTS SHOWED 52% ORR PER BLINDED INDEPENDENT CENTRAL REVIEW AND MEDIAN DURATION OF RESPONSE OF 10.9 MONTHS.  Full Article

Seattle Genetics And Astellas Announce Padcev Improved Overall Survival In Phase 3 Trial In Previously Treated Locally Advanced Urothelial Cancer
Friday, 18 Sep 2020 

Sept 18 (Reuters) - Seattle Genetics Inc ::SEATTLE GENETICS AND ASTELLAS ANNOUNCE PADCEV® (ENFORTUMAB VEDOTIN-EJFV) SIGNIFICANTLY IMPROVED OVERALL SURVIVAL IN PHASE 3 TRIAL IN PREVIOUSLY TREATED LOCALLY ADVANCED OR METASTATIC UROTHELIAL CANCER.SEATTLE GENETICS INC - TRIAL STOPPED EARLY DUE TO POSITIVE RESULTS AT PLANNED INTERIM ANALYSIS.SEATTLE GENETICS INC - DATA INTENDED TO SUPPORT GLOBAL REGISTRATIONS AND CONVERT ACCELERATED TO REGULAR APPROVAL IN U.S.SEATTLE GENETICS INC - PHASE 3 TRIAL OF PADCEV MET ITS PRIMARY ENDPOINT.SEATTLE GENETICS INC - RESULTS WILL BE SUBMITTED TO U.S. FDA AS CONFIRMATORY TRIAL FOLLOWING DRUG'S ACCELERATED APPROVAL IN 2019.SEATTLE GENETICS INC - FOR PATIENTS IN PADCEV ARM OF TRIAL, ADVERSE EVENTS WERE CONSISTENT WITH THOSE LISTED IN U.S.  Full Article

Health Canada Approves Astellas' drug For Acute Myeloid Leukemia
Tuesday, 14 Jan 2020 

Jan 14 (Reuters) - Astellas Pharma Inc <4503.T>::HEALTH CANADA APPROVES ASTELLAS' XOSPATA® (GILTERITINIB) FOR PATIENTS WITH RELAPSED OR REFRACTORY ACUTE MYELOID LEUKEMIA WITH A FLT3 MUTATION.ASTELLAS PHARMA CANADA, INC - HEALTH CANADA HAS APPROVED ORAL ONCE-DAILY THERAPY XOSPATA.  Full Article

Astellas Strengthens Immuno-Oncology Pipeline With Acquisition Of Xyphos Biosciences
Friday, 27 Dec 2019 

Dec 26 (Reuters) - Astellas Pharma Inc <4503.T>::ASTELLAS STRENGTHENS IMMUNO-ONCOLOGY PIPELINE WITH ACQUISITION OF XYPHOS BIOSCIENCES, INC..XYPHOS SHAREHOLDERS TO RECEIVE UP TO $665 MILLION IN STRUCTURED, MILESTONE-BASED ACQUISITION.ASTELLAS PHARMA - IMPACT OF DEAL ON CO'S FINANCIAL RESULTS IN FY ENDING MARCH 31, 2020 TO BE LIMITED.ASTELLAS PHARMA - CONSIDERING ACQUISITION, $120 MILLION WAS PAID UPON CLOSING OF ACQUISITION, AND XYPHOS BECAME WHOLLY OWNED SUBSIDIARY OF ASTELLAS.  Full Article

Astellas Pharma Says Japan's Ministry Of Health, Labour And Welfare Approved Evrenzo(Roxadustat)
Friday, 20 Sep 2019 

Sept 20 (Reuters) - Astellas Pharma Inc <4503.T>::EVRENZO® (ROXADUSTAT) TABLETS APPROVED IN JAPAN FOR TREATMENT OF ANEMIA ASSOCIATED WITH CHRONIC KIDNEY DISEASE IN DIALYSIS PATIENTS.JAPAN'S MINISTRY OF HEALTH, LABOUR AND WELFARE APPROVED EVRENZO.APPROVAL IS BASED ON FOUR PHASE 3 STUDIES CONDUCTED IN CKD ANEMIA PATIENTS ON DIALYSIS IN JAPAN.PHASE 3 STUDIES DEMONSTRATED THAT ROXADUSTAT WAS EFFECTIVE AT RAISING HEMOGLOBIN AND THAT IT WAS WELL-TOLERATED.  Full Article

Seattle Genetics And Astellas Announce U.S. FDA Grants Priority Review For Enfortumab Vedotin Biologics License Application In Locally Advanced Or Metastatic Urothelial Cancer
Monday, 16 Sep 2019 

Sept 16 (Reuters) - Seattle Genetics Inc ::SEATTLE GENETICS AND ASTELLAS ANNOUNCE U.S. FDA GRANTS PRIORITY REVIEW FOR ENFORTUMAB VEDOTIN BIOLOGICS LICENSE APPLICATION IN LOCALLY ADVANCED OR METASTATIC UROTHELIAL CANCER.SEATTLE GENETICS INC - FOOD & DRUG ADMINISTRATION SETS PRESCRIPTION DRUG USER FEE ACTION DATE FOR MARCH 15, 2020.  Full Article

Ironwood Pharmaceuticals To No Longer Be Responsible For Supply Of Linaclotide API To Astellas
Friday, 2 Aug 2019 

Aug 1 (Reuters) - Astellas Pharma Inc <4503.T>::IRONWOOD PHARMACEUTICALS INC - BEGINNING ON JANUARY 1, 2020, CO WILL NO LONGER BE RESPONSIBLE FOR SUPPLY OF LINACLOTIDE API TO ASTELLAS.IRONWOOD PHARMACEUTICALS INC - BEGINNING JAN 1, 2020 ASTELLAS WILL BE RESPONSIBLE FOR ITS OWN SUPPLY OF LINACLOTIDE API FOR SALE IN JAPAN.IRONWOOD PHARMACEUTICALS INC - ASTELLAS HAS COMMITTED TO PURCHASE CERTAIN QUANTITIES OF LINACLOTIDE API FROM CO IN CALENDAR YEAR 2019.IRONWOOD PHARMACEUTICALS INC - IN CONSIDERATION FOR FOREGOING RIGHTS, ASTELLAS WILL PAY IRONWOOD A NON-REFUNDABLE UPFRONT PAYMENT OF $10 MILLION.IRONWOOD - BEGINNING JAN 1, 2020, ASTELLAS TO PAY ROYALTIES TO CO AT RATES BEGINNING IN MID-SINGLE DIGIT PERCENT IN LIEU OF ROYALTY PAYMENT TERMS.IRONWOOD PHARMACEUTICALS INC - ROYALTY PAYMENTS WILL NOT BE DUE ON NET SALES OF PRODUCTS IN CALENDAR YEAR 2019.IRONWOOD - AS RESULT OF EXECUTION OF AMENDED AND RESTATED AGREEMENT, CO NOW EXPECTS TOTAL 2019 REVENUE FROM ASTELLAS TO BE APPROXIMATELY $55 MILLION.  Full Article

Astellas And Frequency Therapeutics Enter Into License Agreement For FX-322
Wednesday, 17 Jul 2019 

July 17 (Reuters) - Astellas Pharma Inc <4503.T>::ASTELLAS AND FREQUENCY THERAPEUTICS ENTER INTO LICENSE AGREEMENT FOR FX-322, A REGENERATIVE TREATMENT CANDIDATE FOR HEARING LOSS.ASTELLAS PHARMA - ASTELLAS WILL BE RESPONSIBLE FOR DEVELOPMENT AND COMMERCIALIZATION OF FX-322 OUTSIDE OF THE U.S..ASTELLAS PHARMA - AS PER LICENSE AGREEMENT, FREQUENCY WILL RECEIVE AN UPFRONT PAYMENT OF $80 MILLION.ASTELLAS PHARMA - AS PER LICENSE AGREEMENT, FREQUENCY MAY ALSO GET UP TO ADDITIONAL $545 MILLION BASED ON DEVELOPMENT & COMMERCIAL MILESTONES, ROYALTIES.ASTELLAS PHARMA - FREQUENCY WILL BE RESPONSIBLE FOR U.S. DEVELOPMENT AND COMMERCIALIZATION FOR FX-322.ASTELLAS PHARMA - FREQUENCY PLANS TO INITIATE PHASE 2A STUDY IN Q4 2019 FOR FX-322.ASTELLAS PHARMA - REFLECTED IMPACT FROM LICENSE AGREEMENT FOR FX-322 IN ITS FINANCIAL FORECASTS OF CURRENT FISCAL YEAR ENDING MARCH 31, 2020.  Full Article

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Bayer takes on Astellas in purchase of experimental menopause relief

FRANKFURT Bayer moved to acquire a prospective non-hormonal menopause relief for an initial $425 million to strengthen its women's healthcare business, in a challenge to a similar development venture at Astellas .