Aug, 2023

Global
News / Press Releases
Notice Regarding Issuance of Unsecured Bonds
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Global
News / Press Releases
FDA Grants Priority Review for XTANDI® in Non-Metastatic Castration-Sensitive Prostate Cancer with High-Risk Biochemical Recurrence
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 New Drug Application (sNDA) for XTANDI® (enzalutamide) for the treatment of patients with non-metastatic castration...
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Global
News / Stories
Can Sustainability Be Globally Driven and Locally Accomplished? Astellas believes it can.
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Global
News / Press Releases
European Medicines Agency Accepts Iveric Bio’s Marketing Authorization Application for Avacincaptad Pegol for Geographic Atrophy
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 (ACP), an investigational complement C5 inhibitor for the treatment of geographic atrophy (GA) secondary to age-related macular...
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Global
News / Press Releases
Astellas to Open New Life Sciences Facility in DivcoWest’s Cambridge Crossing Neighborhood
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 (CX) neighborhood in Cambridge, Mass. This investment establishes a significant presence for...
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Sep, 2023

Global
News / Press Releases
Astellas Announces Personnel Change
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Global
News / Press Releases
PADCEV® (enfortumab vedotin-ejfv) and KEYTRUDA® (pembrolizumab) Significantly Improve Overall Survival and Progression-Free Survival in Patients With Previously Untreated Advanced Bladder Cancer in Pivotal Phase 3 EV-302 Trial
TOKYO and BOTHELL, Wash. – September 22, 2023 -- Astellas Pharma Inc. (TSE:4503, President and CEO: Naoki Okamura, “Astellas”) and Seagen Inc. (Nasdaq: SGEN) today announced positive topline results from the Phase 3 EV-302 clinical trial (also known as KEYNOTE-A39) for PADCEV® (enfortumab vedotin-ejfv) in combination with KEYTRUDA® (pembrolizumab) versus chemotherapy in patients with previously...
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Global
News / Press Releases
China’s National Medical Products Administration Accepts New Drug Application for XTANDI® (enzalutamide) in Metastatic Hormone-Sensitive Prostate Cancer
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 Application (NDA) for XTANDI® (enzalutamide) for the treatment of patients with metastatic hormone-sensitive prostate cancer (mHSPC). Ahsan...
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Global
News / Press Releases
Astellas Highlights VEOZAH™ (fezolinetant) Data at the 2023 Annual Meeting of The Menopause Society
Pooled analyses from pivotal Phase 3 SKYLIGHT™ studies provide new insights into fezolinetant for the treatment of moderate to severe VMS due to menopause Additional presentations highlight real-world data on the prevalence and impact of VMS TOKYO, September 19, 2023 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, “Astellas”) will share new pooled efficacy and safety analyses...
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Global
News / Press Releases
Iveric Bio Announces Positive 24-Month Topline Results from Phase 3 Study of IZERVAY™ (avacincaptad pegol intravitreal solution) for Geographic Atrophy
GATHER2 24-month results met the primary objective of reducing the rate of GA growth in patients treated with IZERVAY compared to sham IZERVAY 24-month safety data were consistent with 12-month results, with no new safety signals identified TOKYO, September 18, 2023 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, “Astellas”) today announced positive 24-month topline results...
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