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Astellas Pharma Inc (4503.T)

4503.T on Tokyo Stock Exchange

1,662JPY
15 Nov 2018
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Latest Key Developments (Source: Significant Developments)

Astellas Submits New Drug Application In Japan Of Roxadustat For Treatment Of Anemia Associated With Chronic Kidney Disease In Patients On Dialysis
Monday, 1 Oct 2018 08:00am EDT 

Oct 1 (Reuters) - FibroGen Inc ::ASTELLAS SUBMITS NEW DRUG APPLICATION IN JAPAN OF ROXADUSTAT FOR THE TREATMENT OF ANEMIA ASSOCIATED WITH CHRONIC KIDNEY DISEASE IN PATIENTS ON DIALYSIS.FIBROGEN INC - ANNOUNCED ASTELLAS SUBMITTED A NEW DRUG APPLICATION (NDA) FOR MARKETING APPROVAL IN JAPAN OF ROXADUSTAT.  Full Article

Astellas Pharma says blincyto® for drip infusion 35 μg approved in Japan for treatment of relapsed or refractory b-cell acute lymphoblastic leukemia
Monday, 24 Sep 2018 10:40pm EDT 

Sept 25 (Reuters) - Astellas Pharma Inc <4503.T>:Amgen Astellas BioPharma K.K. and Astellas Pharma Inc. today announced that Ministry of Health, Labour and Welfare has granted marketing approval for antineoplastic drug/bispecific antibody product.BLINCYTO® Drip Infusion 35 μg for the treatment of relapsed or refractory B-cell acute lymphoblastic leukemia (ALL).  Full Article

Astellas Pharma announces approval in Japan for XOSPATA® 40 mg Tablets for treatment of FLT3mut+ relapsed or refractory AML
Friday, 21 Sep 2018 02:45am EDT 

Sept 21(Reuters) - Astellas Pharma Inc <4503.T>:Says it announced that XOSPATA® Tablets 40 mg, a FLT3 (FMS-like tyrosine kinase 3) inhibitor received manufacturing and marketing approval for the treatment of FLT3 mutation-positive relapsed or refractory acute myeloid leukemia (AML) in Japan.  Full Article

Aquinox Pharmaceuticals Received Notice Terminating License Agreement That Had Been Entered Between Co's Unit And Astellas US LLC
Friday, 7 Sep 2018 06:05pm EDT 

Sept 7 (Reuters) - Astellas Pharma Inc <4503.T>::AQUINOX PHARMACEUTICALS - ON SEPT 4, RECEIVED NOTICE TERMINATING LICENSE AGREEMENT THAT HAD BEEN ENTERED BETWEEN CO'S UNIT AND ASTELLAS US LLC.AQUINOX PHARMACEUTICALS INC - TERMINATION OF THE ASTELLAS AGREEMENT WILL BE EFFECTIVE MARCH 4, 2019- SEC FILING.  Full Article

Astellas Pharma Considering Sale Of Some Central And Eastern European Assets- Bloomberg
Wednesday, 18 Jul 2018 01:00pm EDT 

July 18 (Reuters) - :ASTELLAS PHARMA IS CONSIDERING A SALE OF SOME CENTRAL AND EASTERN EUROPEAN ASSETS- BLOOMBERG,CITING SOURCES.  Full Article

FDA Approves XTANDI For Treating Men With Non-Metastatic Castration-Resistant Prostate Cancer
Friday, 13 Jul 2018 02:30pm EDT 

July 13 (Reuters) - Astellas Pharma Inc <4503.T>::U.S. FDA APPROVES XTANDI® (ENZALUTAMIDE) FOR THE TREATMENT OF MEN WITH NON-METASTATIC CASTRATION-RESISTANT PROSTATE CANCER (CRPC).U.S. FDA APPROVES XTANDI® (ENZALUTAMIDE) FOR THE TREATMENT OF MEN WITH NON-METASTATIC CASTRATION-RESISTANT PROSTATE CANCER (CRPC).ASTELLAS PHARMA - U.S. FDA APPROVES XTANDI FOR TREATING MEN WITH NON-METASTATIC CASTRATION-RESISTANT PROSTATE CANCER BASED ON RESULTS FROM PHASE 3 PROSPER TRIAL.  Full Article

Seattle Genetics, Astellas Announce Progress In Enfortumab Vedotin Urothelial Cancer Clinical Development Program
Monday, 9 Jul 2018 08:00am EDT 

July 9 (Reuters) - Astellas Pharma Inc <4503.T>::SEATTLE GENETICS AND ASTELLAS ANNOUNCE PROGRESS IN ENFORTUMAB VEDOTIN UROTHELIAL CANCER CLINICAL DEVELOPMENT PROGRAM.SEATTLE GENETICS INC - ENROLLMENT OF EV-201 PIVOTAL TRIAL COHORT DESIGNED TO SUPPORT POTENTIAL EXPEDITED REGISTRATION PATHWAY IN U.S. COMPLETED.  Full Article

Astellas, Fibrogen Announce Topline Results From Japan Phase 3 Study Of Roxadustat
Thursday, 31 May 2018 07:31am EDT 

May 31 (Reuters) - Astellas Pharma Inc <4503.T>::ASTELLAS & FIBROGEN ANNOUNCE TOPLINE RESULTS FROM DOUBLE-BLIND JAPAN PHASE 3 STUDY FOR ROXADUSTAT IN HEMODIALYSIS CHRONIC KIDNEY DISEASE PATIENTS WITH ANEMIA.ASTELLAS PHARMA INC - FOURTH JAPAN PHASE 3 STUDY FOR ROXADUSTAT MET ITS PRIMARY ENDPOINT.ASTELLAS PHARMA INC - ROXADUSTAT WAS WELL TOLERATED IN STUDY.ASTELLAS PHARMA INC - SAFETY PROFILE OF ROXADUSTAT WAS CONSISTENT WITH THAT OBSERVED IN PREVIOUS STUDIES BOTH IN DIALYSIS AND NON-DIALYSIS PATIENTS.  Full Article

Astellas Pharma submits application for marketing approval of peficitinib for rheumatoid arthritis
Thursday, 31 May 2018 02:38am EDT 

May 31 (Reuters) - Astellas Pharma Inc <4503.T>:Says it has submitted an application for marketing approval of peficitinib hydrobromide for the treatment of rheumatoid arthritis (including prevention of structural joint damage) in patients who have an inadequate response to conventional therapy in Japan.  Full Article

Astellas Says To Buy Back Up To 100 Billion Yen Of Stock
Thursday, 31 May 2018 02:00am EDT 

May 31 (Reuters) - Astellas Pharma Inc <4503.T>::ASTELLAS SAYS TO BUY BACK UP TO 100 BILLION YEN OF STOCK.  Full Article

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Pfizer, Astellas revise two cancer drug trial protocols to speed up results

Drugmakers Pfizer Inc and Astellas Pharma Inc said on Wednesday they would change protocols for two late-stage trials testing prostate cancer drug Xtandi to speed up completion.