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TOKYO, September 19, 2023 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, “Astellas”) today announced that the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) has accepted its New Drug...
TOKYO, September 18, 2023 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, “Astellas”) today announced positive 24-month topline results from the Phase 3 GATHER2 clinical trial evaluating the efficacy and safety of IZERVAY™...
TOKYO, September 14, 2023 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, “Astellas”) today announced its intention to submit a planning application to build a new state-of-the-art facility, at an approximate cost of €330 million in Tralee, Co. Kerry...
TOKYO, September 12, 2023 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, “Astellas”) today announced that the European Medicines Agency (EMA) has validated its Type II variation for XTANDI® (enzalutamide) for the treatment of patients with non-metastatic...
TOKYO, August 25, 2023 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, “Astellas”) successfully priced a dual-tranche of series 3rd and 4th JPY denominated unsecured bonds...
NEW YORK and TOKYO, August 23, 2023 – Pfizer Inc. (NYSE: PFE) and Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, “Astellas”) today announced that the U.S. Food and Drug Administration (FDA) has accepted and granted Priority Review for the companies’ supplemental...
TOKYO, August 18, 2023 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, “Astellas”), today announced the European Medicines Agency (EMA) has accepted for regulatory review the marketing authorization application (MAA) for avacincaptad pegol...
TOKYO and SAN FRANCISCO, August 9, 2023 - Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, “Astellas”) and DivcoWest, a DivCore Capital Company, announced today plans for Astellas to open a new state-of-the-art life sciences facility at 441 Morgan Avenue, in the Cambridge Crossing...
TOKYO and SAN DIEGO, August, 7, 2023 -- Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, "Astellas") and Poseida Therapeutics, Inc. (NASDAQ: PSTX, CEO: Mark Gergen, "Poseida") today announced a strategic investment to support the advancement of Poseida's commitment to redefining cancer cell therapy...
TOKYO, August 5, 2023 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, “Astellas”), today announced the U.S. Food and Drug Administration (FDA) approved IZERVAY™ (avacincaptad pegol intravitreal solution) for the treatment of geographic atrophy (GA) secondary...
TOKYO, August 1, 2023 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, “Astellas”) constantly reviews its allocation of managerial resources, in order to adapt flexibly to the rapidly changing business environment and to reinforce its medium...
TOKYO, July 31, 2023 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, “Astellas”) today announced that the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) has accepted the Biologics License...
TOKYO and KANAGAWA, July 25, 2023 - Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, “Astellas”) and PeptiDream Inc. (TSE: 4587, President and CEO: Patrick C. Reid, “PeptiDream”) today announced a research collaboration and license agreement...
TOKYO, Emeryville, California and Columbia, Maryland, July 18, 2023 - Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, “Astellas”) and Eko Health Inc. (Co-Founder and CEO: Connor Landgraf, “Eko”) announced today that they have entered into a License & Supply Agreement...
TOKYO, July 13, 2023 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, “Astellas”) today announced the European Medicines Agency (EMA) has accepted for regulatory review the company’s marketing authorization application (MAA) for...
Tokyo and Parsippany, New Jersey, July 11, 2023 - Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, “Astellas”) today announced that it has successfully completed the acquisition of IVERIC bio, Inc. (NASDAQ: ISEE, CEO: Glenn P. Sblendorio, “Iveric...
TOKYO and EMERYVILLE, Calif., July 10, 2023 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, “Astellas”) and 4D Molecular Therapeutics, Inc. (NASDAQ: FDMT, CEO: David Kirn, MD, “4DMT”) today announced a license agreement under which...
TOKYO, July 6, 2023 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, “Astellas”) today announced that the U.S. Food and Drug Administration (FDA) has accepted and granted Priority Review for the company’s Biologics License Application (BLA) for zolbetuximab, a first-in-class...
TOKYO, June 29, 2023 - Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, “Astellas”) and Mitsui Fudosan Co., Ltd. (TSE: 8801, President and CEO: Takashi Ueda, “Mitsui Fudosan”) announced today that Astellas will establish...
TOKYO, June 27, 2023 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, “Astellas”) today announced positive topline results from the Phase 3b DAYLIGHT clinical trial for fezolinetant, an investigational oral, nonhormonal...
TOKYO and SAN DIEGO, June 14, 2023 - Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, “Astellas”) and Cullgen Inc. (President and CEO: Ying Luo, Ph.D., “Cullgen”) today announced a research collaboration and exclusive option agreement to discover multiple innovative protein degraders...
TOKYO, June 12, 2023 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, “Astellas”) confirmed the U.S. District Court for the District of Delaware issued a decision on June 9 finding U.S. Patent No. 10,842,780...
TOKYO, June 9, 2023 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, “Astellas”) today announced the submission of a New Drug Application (NDA) on June 9, 2023 to Japan's Ministry of Health, Labour and Welfare (MHLW) for zolbetuximab...
TOKYO and ROCKVILLE, Md., June 9, 2023 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, “Astellas”) and the Blood and Marrow Transplant Clinical Trials Network (BMT CTN) today presented data from the Phase 3 MORPHO clinical trial which demonstrated favorable results in subgroups...
TOKYO and SAN DIEGO, June 8, 2023 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, “Astellas”), and Kate Therapeutics (“KateTx”) today announced an exclusive license agreement to develop and commercialize KT430. KT430 is a preclinical next-generation...
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