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TOKYO, March 31, 2021 - Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., “Astellas” ) today announced that it will further integrate its wholly owned subsidiary, Audentes Therapeutics, and establish “Astellas Gene Therapies” within the organization...
TOKYO, March 30, 2021 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., “Astellas”) today announced that a Phase 3 confirmatory trial of XOSPATA® (gilteritinib) in patients with relapsed (disease that has returned) or refractory (resistant to...
TOKYO, March 29, 2021 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., “Astellas”) announced today the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion...
TOKYO, March 26, 2021 - Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., “Astellas” ) has entered into two joint research agreements today to maximize the value of medications using AI and statistical methods. One agreement is with the...
TOKYO, March 26, 2021 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., “Astellas”) announced today that the U.S. Food and Drug Administration (FDA) approved Myrbetriq® (mirabegron extended-release tablets) for the treatment...
TOKYO and BOTHELL, Wash. – March 26, 2021 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., “Astellas”) and Seagen Inc. (Nasdaq:SGEN) today announced that a marketing authorization application (MAA) for enfortumab vedotin was...
TOKYO, March 11, 2021 - Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., "Astellas") today announced the submission of a New Drug Application (NDA) to Japan's Ministry of Health, Labour and Welfare (MHLW) for enfortumab vedotin...
TOKYO, February 26, 2021 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., “the Company”) announced that at the meeting of the Board of Directors held today...
TOKYO, February 19, 2021 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., “Astellas”) today announced positive topline results from the Phase 3 pivotal SKYLIGHT 1™ and SKYLIGHT 2™ clinical trials for fezolinetant, an investigational...
TOKYO and BOTHELL, Wash. – Feb. 18, 2021 -- Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., “Astellas”) and Seagen Inc. (Nasdaq:SGEN) today announced completion of submissions for two supplemental Biologics License Applications...
TOKYO and BOTHELL, Wash. – February 12, 2021 -- Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., “Astellas”) and Seagen Inc. (Nasdaq:SGEN) today announced results from the second cohort (cohort 2) of patients in the pivotal phase 2 single-arm...
TOKYO and BOTHELL, Wash. – February 12, 2021 -- Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., “Astellas”) and Seagen Inc. (Nasdaq:SGEN) today announced primary results from the phase 3 EV-301 trial comparing PADCEV®...
TOKYO, February 4, 2021 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., “Astellas”) today announced that the China National Medical Products Administration (NMPA) has granted conditional approval to XOSPATA® (gilteritinib) for the treatment...
TOKYO, February 4, 2021 - Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., “Astellas” ) today announced the following Executive Comittee Standing Members effective from...
TOKYO, February 1, 2021 - Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., “Astellas”) today announced that its subsidiary, Astellas Pharma Europe Ltd. (“Astellas Europe”), and Tolmar International Limited (“Tolmar”) have entered into an agreement...
TOKYO, January 25, 2021 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., “Astellas”) today announced that construction of new manufacturing lines for aseptic drug products utilizing new modalities and technologies has commenced...
TOKYO, January 13, 2021 - Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., “Astellas” ) has entered into a research collaboration for molecular targeted radiotherapies with Actinium Pharmaceuticals, Inc. (NYSE AMERICAN: ATNM, Chief...
TOKYO, January 6, 2021 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., “Astellas”) announced today that the U.S. Food and Drug Administration (FDA) accepted priority review for its New Drug Application (NDA) for mirabegron for oral...
TOKYO, December 25, 2020 - Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., “Astellas” ) today announced that its wholly owned subsidiary Audentes Therapeutics, Inc. (“Audentes” ) has been notified that the U.S. Food and Drug...
TOKYO, December 21, 2020 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., “Astellas”) today announced that a Phase 3 trial of XOSPATA® (gilteritinib) plus azacitidine versus azacitidine alone in newly diagnosed FLT3 mutation-positive (FLT3mut+)...
TOKYO, December 17, 2020 - Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., “Astellas”) expressed its support for the recommendation of the Task Force on Climate-related Financial Disclosures*1 (TCFD), established by the Financial...
TOKYO, December 16, 2020 - Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., “Astellas” ) today announced that Astellas will open a new logistics center for the Kyushu area in Kitakyushu City, Fukuoka Prefecture...
PITTSBURGH, PA and TOKYO, December 7, 2020 – KaliVir Immunotherapeutics LLC (CEO: Helena Chaye, Ph.D., J.D., “KaliVir”) and Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., “Astellas”) announced today that they entered...
TOKYO, December 7, 2020 - Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., “Astellas” ) and Viatris Pharmaceuticals Japan Inc. (Country Manager: Sun-A Kim, “Viatris”) announced that the two companies have agreed to end the joint...
TOKYO, November 27, 2020 - Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., “Astellas” ) today announced that the subsidiary Astellas Pharma Europe Ltd. (“Astellas Europe”) and Tillotts Pharma AG (“Tillotts”) have entered into an...
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