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Press Releases |
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Monday, June 12, 2023 |
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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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エーザイ、抗アミロイドβプロトフィブリル抗体「レカネマブ」について、韓国において早期アルツハイマー病に係る適応で新薬承認を申請 |
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、エーザイが抗アミロイドβ(Aβ)プロト フィブリル*抗体レカネマブ(一般名、米国ブランド名:「LEQEMBI(R)」)について、脳内アミロイド病理が確認された早期アルツハイマー病(アルツハイマー病(AD)による軽度認知障害および軽度認知症)に係る適応で、韓国食品医薬品安全処(MFDS)に新薬承認申請を行いましたのでお知らせします。 more info >> |
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Friday, June 2, 2023 |
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Eisai to Present Latest Data on Lemborexant at the 37th Annual Sleep 2023 Meeting |
Eisai Co., Ltd. announced a total of eight poster presentations, including the latest data on its in-house discovered orexin receptor antagonist lemborexant (product name: DAYVIGO), will be given at the 37th annual meeting of the Associated Professional Sleep Societies (SLEEP 2023), to be held from June 3 to 7, 2023 in Indianapolis, IN, the United States. more info >> |
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Friday, May 26, 2023 |
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LENVIMA (lenvatinib) Plus KEYTRUDA (pembrolizumab) Demonstrates Long-Term, Durable Survival Benefit Versus Sunitinib as First-Line Treatment for Patients With Advanced Renal Cell Carcinoma |
These data will be presented on Monday, June 5 at 11:54 a.m. Central Daylight Time during an oral abstract session at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting (Abstract #4502). more info >> |
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Wednesday, November 2, 2022 |
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Eisai Announces Plans to Submit Application for Partial Change to Label for Dosage and Administration of Aricept for Treatment of Dementia with Lewy Bodies Based on Results of Drug Reexamination |
Eisai Co., Ltd. announced today that it has received notification that Aricept (donepezil hydrochloride), a treatment for Alzheimer's disease and dementia with Lewy bodies that was discovered and developed in-house, has been granted Category 2* status based on the results of a reexamination of its efficacy, dosage and administration for the treatment of dementia with Lewy bodies (DLB) in Japan. more info >> |
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Monday, October 31, 2022 |
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エーザイ、「アリセプト(R)」について日本のレビー小体型認知症に係る適応に関する再審査結果に伴う用法・用量の一部変更申請の予定について発表 |
エーザイ株式会社(本社:東京都、代表執行役 CEO:内藤晴夫)は、本日、自社創製のアルツハイマー型認知症・レビー小体型認知症治療剤「アリセプト(R)」(一般名:ドネペジル塩酸塩)について、日本におけるレビー小体型認知症(DLB)に係る効能・効果および用法・用量に関する再審査の結果、カテゴリー2*となった旨の通知を受領しました。 more info >> |
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Tuesday, October 4, 2022 |
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Eisai Completes Construction of Its New Injection/Research Building at Kawashima Industrial Park in Japan |
Eisai Co., Ltd. announced that, as part of the strategic investment towards the realization of its medium-term business plan "EWAY Future & Beyond", it has completed construction of the new injection/research building "Eisai Medicine Innovation Technology Solutions" ("EMITS") at the Kawashima Industrial Park located in Gifu Prefecture, Japan. more info >> |
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エーザイ、川島工園において新注射剤棟/研究棟が竣工 |
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、当社の中期経営計画 EWAY Future & Beyond における戦略投資の一環として、川島工園(岐阜県)において建設中であった新注射剤棟/研究棟(名称:Eisai Medicine Innovation Technology Solutions、以下 EMITS)が竣工したことをお知らせします。 more info >> |
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Wednesday, September 28, 2022 |
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Eisai's Lecanemab Confirmatory Phase 3 Clarity AD Study Met Primary Endpoint |
Eisai Co., Ltd. and Biogen Inc. announced positive topline results from Eisai's large global Phase 3 confirmatory Clarity AD clinical trial of lecanemab. more info >> |
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Latest Press Releases |
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Funimation Founder, Gen Fukunaga, Joins as Investor and Advisor to Toonsutra, India's #1 Webtoon App
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Domino's Pizza Inc. Is Being Investigated by Kaplan Fox & Kilsheimer LLP for Potential Securities Law Violations
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CORRECTION FROM SOURCE: Doubleview Reports Maiden Mineral Resource Estimate
Jul 26, 2024 21:00 HKT/SGT
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CITIC Resources Announces its 2024 Interim Results
Jul 26, 2024 20:43 HKT/SGT
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中信資源公布2024年度中期業績 收入大幅增長93.1%至約39.4億港元
Jul 26, 2024 20:29 HKT/SGT
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OmniGuide Holdings Announces Successful Completion of Patient Study for Revolutionary iSTONE(TM) Laser-Guided Lithotripsy Technology
Jul 26, 2024 20:05 HKT/SGT
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VCI Global Enters into AI Computing Alliance (AICA) Led by Enlight Corporation and Supermicro
Jul 26, 2024 20:00 HKT/SGT
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中信资源公布2024年度中期业绩 收入大幅增长93.1%至约39.4亿港元
Jul 26, 2024 19:57 HKT/SGT
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華邦科技集團成員及策略夥伴攬獲「專業金融機構服務大獎2024」兩項殊榮 [更新版]
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华邦科技集团成员及策略伙伴揽获“专业金融机构服务大奖2024”两项殊荣[更新版]
Jul 26, 2024 17:18 HKT/SGT
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DOCOMO and NTT Com Jointly Demonstrate Practicality of DOCOMO's New Multi-platform Cloud-rendering Technology
Jul 26, 2024 17:05 JST
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Kucingko Berhad Debuts on ACE Market with Clawsome Opening Price of RM0.805
Jul 26, 2024 15:00 HKT/SGT
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More News >> |
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