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Press Releases |
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Wednesday, July 12, 2023 |
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Eisai to Present the Latest Alzheimer's Disease Pipeline and Research |
Eisai Co. Ltd announced today that the company will present the latest findings on its Alzheimer's disease (AD) pipeline and research, including Eisai's anti-amyloid beta (Abeta) protofibril* antibody for the treatment of Alzheimer's disease (AD). more info >> |
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Friday, July 7, 2023 |
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Eisai: FDA Grants Traditional Approval for LEQEMBI (lecanemab-irmb) for the Treatment of Alzheimer's Disease |
Eisai Co., Ltd. and Biogen Inc. announced today that the U.S. Food and Drug Administration (FDA) has approved the supplemental Biologics License Application (sBLA) supporting the traditional approval of LEQEMBI more info >> |
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エーザイとバイオジェン・インク、「LEQEMBI(R)」(レカネマブ)がアルツハイマー病治療薬として米国FDAよりフル承認を取得 |
エーザイ株式会社(本社:東京都、代表執行役CEO:内藤晴夫、以下 エーザイ)とバイオジェン・インク(Nasdaq:BIIB、本社:米国マサチューセッツ州ケンブリッジ、CEO:Christopher A. Viehbacher、以下 バイオジェン)は、このたび、米国食品医薬品局(FDA)が「LEQEMBI(R)」注射100 mg/mL溶液(一般名:レカネマブ)について、フル承認に向けた生物製剤承認一部変更申請(supplemental Biologics License Application:sBLA)を承認したことをお知らせします。 more info >> |
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Friday, June 30, 2023 |
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New NEURii Research Collaboration Between Eisai, Gates Ventures, Health Data Research UK, Lifearc and The University of Edinburgh to Develop Digital Solutions for Dementia is Announced |
Eisai, Gates Ventures, Health Data Research UK (HDR UK), LifeArc and The University of Edinburgh announced today a new two-year collaborative research agreement. more info >> |
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Thursday, June 29, 2023 |
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エーザイ、Gates Ventures、Health Data Research UK、LifeArc、およびエジンバラ大学は認知症の課題解決に寄与するデジタル・ソリューション開発をめざす共同研究「NEURii」を開始 |
エーザイ株式会社(本社:東京都)、Gates Ventures(米国、シアトル)、Health Data Research UK(英国、ロンドン、以下、HDR UK)、LifeArc(英国、ロンドン)、およびエジンバラ大学(英国、エジンバラ)は、このたび、2年間の新規共同研究契約を締結したことをお知らせします。 more info >> |
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Thursday, June 22, 2023 |
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Eisai's "Nouknow" Will Continue to be Utilized for Brain Health Assessment as Part of The FY2023 Dementia Examination Project by Tokyo Bunkyo City |
Eisai Co., Ltd. announced today that brain health checks utilizing "NouKNOW" (pronounced "NOH-NOH"), Eisai's digital tool for self-assessment of cognitive function, will continue to be promoted as part of the FY2023 dementia examination project, conducted by Bunkyo City, Tokyo. more info >> |
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エーザイ、東京都文京区の2023年度認知症検診事業において「のうKNOW(R)」による脳の健康度測定を継続実施 |
エーザイ株式会社(本社:東京都、代表執行役CEO:内藤晴夫)は、このたび、東京都文京区(以下、文京区)が実施する2023年度認知症検診事業(以下、本事業)において、当社の認知機能のデジタルチェックツール「のうKNOW(R)」による脳の健康度測定が継続実施されることをお知らせします。 more info >> |
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Monday, June 12, 2023 |
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FDA Advisory Committee Votes Unanimously to Confirm the Clinical Benefit of LEQEMBI (lecanemab-irmb) for the Treatment of Alzheimer's Disease |
Eisai Co., Ltd. and Biogen Inc. announced today that the U.S. Food and Drug Administration's (FDA) Peripheral and Central Nervous System Drugs Advisory Committee (PCNS) voted unanimously that the data from Eisai's Phase 3 Clarity AD clinical trial confirms the clinical benefit of LEQEMBI (lecanemab-irmb) 100 mg/mL injection for intravenous use for the treatment of Alzheimer's disease (AD). more info >> |
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エーザイ、米国FDA諮問委員会は全会一致でアルツハイマー病治療薬「LEQEMBI(R)」(レカネマブ)の臨床上のベネフィットを支持 |
エーザイ株式会社(本社:東京都、代表執行役CEO:内藤晴夫、以下 エーザイ)とバイオジェン・インク(Nasdaq:BIIB、本社:米国マサチューセッツ州ケンブリッジ、CEO:Christopher A. Viehbacher、以下 バイオジェン)は、このたび、米国食品医薬品局(FDA)の末梢・中枢神経系薬物諮問委員会(Peripheral and Central Nervous System Drugs Advisory Committee、以下 本諮問委員会)が開催され、「LEQEMBI(R)」注射100 mg/mL溶液(一般名:レカネマブ)の臨床第III相Clarity AD検証試験の結果が、本剤の臨床上のベネフィットを示すエビデンスであることが、全会一致で支持されましたのでお知らせします。 more info >> |
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Thursday, June 8, 2023 |
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Eisai Files Marketing Authorization Application for Lecanemab as Treatment For Early Alzheimer's Disease in South Korea |
This application is the first application for lecanemab in Asia outside of Japan and China. Eisai plans to submit additional applications in other Asian countries. more info >> |
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