Sep, 2023

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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Global
News / Press Releases
Astellas to Invest more than €330 Million in a New State-of-the-Art Facility in Tralee, Co. Kerry. Ireland
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. This investment by Astellas in Ireland will expand our capacity and capabilities for aseptic drug products, reinforce stable...
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Global
News / Press Releases
European Medicines Agency Validates Type II Variation for Astellas' XTANDI® (enzalutamide) for Treatment of Non-Metastatic Hormone-Sensitive Prostate Cancer with High-Risk Biochemical Recurrence
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 hormone-sensitive prostate cancer (nmHSPC; also known as non-metastatic castration-sensitive prostate cancer or nmCSPC)...
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Global
News / Stories
World Patient Safety Day: Elevate the voice of patients!
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Global
News / General News
Legal Action on the Inflation Reduction Act (IRA) by Astellas Pharma US（update）
Astellas Pharma US announced a Statement Regarding the Inflation Reduction Act (IRA). For more information, please visit the Astellas Pharma US website
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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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