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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...
TOKYO, May 25, 2023 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, “Astellas”) today announced that Astellas B.V. and Astellas Pharma Europe B.V., Astellas’ subsidiaries in Netherlands, have made an intended decision...
TOKYO, May 25, 2023 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, “Astellas”) today announced that it has committed to supporting the 3rd phase of the Global Health Innovative Technology Fund...
TOKYO, May 25, 2023 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki
Okamura, “Astellas”) will share new research from across its expanding portfolio of approved
and investigational cancer therapies during the 2023 American Society of Clinical Oncology...
TOKYO, May 17, 2023– Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, “the Company”) today announced that at the meeting of the Board of Directors held today...
TOKYO, May 17, 2023 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, “the Company”) announced that at the meeting of the Board of Directors held today, a resolution was passed to continue...
TOKYO, May 16, 2023 – Sony Corporation (President and CEO: Kimio Maki, “Sony”) and Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, “Astellas”) today announced that they have entered into a collaborative research agreement to discover a novel Antibody-Drug Conjugate...
TOKYO, May 13 2023 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, “Astellas”) today announced that the U.S. Food and Drug Administration (FDA) has approved VEOZAHTM (fezolinetant) 45 mg once daily for the treatment...
TOKYO, May 11, 2023 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, “Astellas”) today confirmed that the Court of Appeals for the Federal Circuit (CAFC) issued a Mandate that officially ends the CAFC appeal on patent infringement...
Tokyo and Parsippany, New Jersey, April 30, 2023 - Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, “Astellas”) and Iveric bio, Inc. (NASDAQ: ISEE, CEO: Glenn P. Sblendorio, “Iveric Bio”) today announced that on April 29, 2023...
TOKYO and NEW YORK, April 29, 2023 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, “Astellas”) and Pfizer Inc. (NYSE: PFE) announced today that XTANDI® (enzalutamide) plus leuprolide significantly reduced the risk of metastasis...
TOKYO, April 27, 2023 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, “Astellas”) today announced that at a meeting of its Board of Directors held today, it decided changes of...
TOKYO, April 14, 2023 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, “Astellas”) today announced that The Lancet published detailed data from the Phase 3 SPOTLIGHT trial evaluating first-line treatment with zolbetuximab, an investigational first-in-class Claudin...
Kyoto and Tokyo, April 12, 2023 - The Center for iPS Cell Research and Application, Kyoto University (Director: Dr. Jun Takahashi; “CiRA”) and Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, “Astellas”) entered into the second phase...
TOKYO, April 11, 2023 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, “Astellas”) today announced that it expects to book an impairment loss of approximately ¥58.0 billion as other expenses in the fourth quarter of fiscal year 2022...
TOKYO and BOTHELL, Wash. – April 3, 2023 -- Astellas Pharma Inc. (TSE:4503, President and CEO: Naoki Okamura, “Astellas”) and Seagen Inc. (Nasdaq: SGEN) today announced the U.S. Food and Drug Administration (FDA) has granted PADCEV®...
TOKYO and Columbia, Maryland, March 29, 2023 - Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., “Astellas”) today announced that it has entered into an agreement ("the Agreement") with Roche Diabetes Care Japan Co., Ltd...
TOKYO, March 28, 2023 – Astellas Pharma Inc. (TSE: 4503, President and CEO:
Kenji Yasukawa, Ph.D.) today announced the following personnel change...
TOKYO, March 22, 2023 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., “Astellas”) will present detailed results from the Phase 3 GLOW trial evaluating first-line treatment with zolbetuximab, an investigational first-in-class Claudin...
NEW YORK and TOKYO, March 17, 2023 – Pfizer Inc. (NYSE: PFE) and Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., “Astellas”) today announced positive topline...
TOKYO, March 16, 2023 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., “Astellas”) today announced the status and the completion of acquisition of its own shares based on the resolution of the Board of Directors' meeting held on February...
TOKYO, MARCH 14, 2023 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., “Astellas”) today announced positive topline results from the Phase 3 China ARCHES study of XTANDI® (enzalutamide) plus androgen deprivation therapy...
TOKYO, March 13, 2023 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., “Astellas”) today announced The Lancet published detailed results from the pivotal Phase 3 SKYLIGHT 1™ study of fezolinetant, an investigational oral, nonhormonal...
TOKYO and ROCKVILLE, Md., March 9, 2023 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., “Astellas”) and the Blood and Marrow Transplant Clinical Trials Network (BMT CTN) today announced topline results from the Phase 3 MORPHO clinical...
TOKYO and BOTHELL, Wash.– March 9, 2023 -- Astellas Pharma Inc. (TSE:4503, President and CEO: Kenji Yasukawa, Ph.D., “Astellas”) and Seagen Inc. (Nasdaq: SGEN) today announced that the Center for Drug Evaluation (CDE) of the China National Medical Products...
TOKYO, March 1, 2023 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D. “the Company”) announced the status of acquisition of its own shares as stated below. The acquisition was implemented pursuant to the provision of its Articles of Incorporation...
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