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Astellas Pharma Inc (4503.T)

4503.T on Tokyo Stock Exchange

1,506JPY
17 May 2019
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Latest Key Developments (Source: Significant Developments)

Xencor And Astellas Enter Collaboration For Novel Bispecific Antibody Program
Tuesday, 2 Apr 2019 08:01am EDT 

April 2 (Reuters) - Xencor: :XENCOR AND ASTELLAS ENTER COLLABORATION FOR NOVEL BISPECIFIC ANTIBODY PROGRAM.XENCOR INC - ASTELLAS TO RECEIVE EXCLUSIVE WORLDWIDE LICENSE TO POTENTIAL DRUG CANDIDATES.XENCOR INC - PARTNERS TO GENERATE NOVEL BISPECIFIC ANTIBODIES DIRECTED TOWARD AN ANTI-TUMOR TARGET IDENTIFIED BY ASTELLAS.XENCOR INC - WILL RECEIVE AN UPFRONT PAYMENT.XENCOR - ELIGIBLE TO RECEIVE DEVELOPMENT, REGULATORY, SALES MILESTONE PAYMENTS & HIGH-SINGLE DIGIT TO LOW-DOUBLE DIGIT PERCENT ROYALTIES ON NET SALES.  Full Article

Phase 3 ADMIRAL Trial Data Show XOSPATA Significantly Prolongs Overall Survival in Adult Patients with a form of leukemia
Monday, 1 Apr 2019 08:31am EDT 

April 1 (Reuters) - Astellas Pharma Inc <4503.T>::PHASE 3 ADMIRAL TRIAL DATA SHOW XOSPATA® (GILTERITINIB) SIGNIFICANTLY PROLONGS OVERALL SURVIVAL IN ADULT PATIENTS WITH FLT3 MUTATION-POSITIVE RELAPSED/REFRACTORY ACUTE MYELOID LEUKEMIA COMPARED WITH SALVAGE CHEMOTHERAPY.ASTELLAS PHARMA - RESULTS SHOW PATIENTS TREATED WITH XOSPATA HAD SIGNIFICANTLY LONGER OS THAN THOSE WHO RECEIVED STANDARD SALVAGE CHEMOTHERAPY.  Full Article

Astellas Presents Fezolinetant Phase 2B Clinical Trial Results At Endocrine Society's Annual Meeting (Endo)
Tuesday, 26 Mar 2019 12:00pm EDT 

March 26 (Reuters) - Astellas Pharma Inc <4503.T>::ASTELLAS PRESENTS FEZOLINETANT PHASE 2B CLINICAL TRIAL RESULTS AT ENDOCRINE SOCIETY'S ANNUAL MEETING (ENDO).ASTELLAS PHARMA INC - INVESTIGATIONAL COMPOUND FEZOLINETANT REDUCED FREQUENCY AND SEVERITY OF VASOMOTOR SYMPTOMS IN POSTMENOPAUSAL WOMEN.ASTELLAS PHARMA INC - OVERALL TREATMENT-EMERGENT ADVERSE EVENT RATES WERE SIMILAR ACROSS GROUPS AND MOSTLY MILD OR MODERATE FOR FEZOLINETANT.  Full Article

Astellas Pharma To Buy Back Up To 40 Million Shares Worth 60 Billion Yen Through March 20
Wednesday, 30 Jan 2019 10:01pm EST 

Jan 31 (Reuters) - Astellas Pharma Inc <4503.T>::TO BUY BACK UP TO 40 MILLION SHARES WORTH 60 BILLION YEN THROUGH MARCH 20.  Full Article

Astellas And Pfizer Announce Positive Top-Line Results From Phase 3 Arches Trial Of Xtandi
Thursday, 20 Dec 2018 09:00am EST 

Dec 20 (Reuters) - Pfizer Inc ::ASTELLAS AND PFIZER ANNOUNCE POSITIVE TOP-LINE RESULTS FROM PHASE 3 ARCHES TRIAL OF XTANDI® (ENZALUTAMIDE) IN MEN WITH METASTATIC HORMONE-SENSITIVE PROSTATE CANCER.ASTELLAS AND PFIZER ANNOUNCE POSITIVE TOP-LINE RESULTS FROM PHASE 3 ARCHES TRIAL OF XTANDI® (ENZALUTAMIDE) IN MEN WITH METASTATIC HORMONE-SENSITIVE PROSTATE CANCER.PFIZER INC - PHASE 3 ARCHES TRIAL MET ITS PRIMARY ENDPOINT.PFIZER INC - PRELIMINARY SAFETY ANALYSIS OF ARCHES TRIAL APPEARS CONSISTENT WITH SAFETY PROFILE OF XTANDI IN PREVIOUS CLINICAL TRIALS.PFIZER - RESULTS FROM ARCHES DEMONSTRATE STATISTICALLY SIGNIFICANT IMPROVEMENT IN MARKER OF DISEASE PROGRESSION, RADIOGRAPHIC PROGRESSION-FREE SURVIVAL.  Full Article

Astellas Pharma Inc Says FDA Approves Xospata, Marking U.S. Entry Into Blood Cancer Treatment
Wednesday, 28 Nov 2018 06:55pm EST 

Nov 29 (Reuters) - Astellas Pharma Inc <4503.T>::U.S. FDA APPROVES XOSPATA FOR ADULT PATIENTS WITH RELAPSED/REFRACTORY ACUTE MYELOID LEUKEMIA WITH FLT3 MUTATION.XOSPATA IS ONLY FLT3 INHIBITOR APPROVED BY FDA FOR PATIENTS WITH RELAPSED OR REFRACTORY AML WITH FLT3 MUTATION.XOSPATA APPROVAL MARKS ASTELLAS'S U.S. ENTRY INTO TREATMENT OF BLOOD CANCERS.  Full Article

FDA Approves Astellas Pharma's Xospata Tablets
Wednesday, 28 Nov 2018 02:19pm EST 

Nov 28 (Reuters) - U.S. Food and Drug Administration::FDA APPROVES ASTELLAS PHARMA'S XOSPATA (GILTERITINIB) TABLETS, FOR ORAL USE.FDA - XOSPATA INDICATED FOR TREATING ADULT PATIENTS WITH RELAPSED/REFRACTORY ACUTE MYELOID LEUKEMIA WITH A FLT3 MUTATION AS DETECTED BY FDA-APPROVED TEST.  Full Article

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

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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.