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Press Releases |
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Saturday, May 20, 2023 |
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Eisai Submits Marketing Authorization Application for Lecanemab as Treatment for Early Alzheimer's Disease in Great Britain |
Eisai Co., Ltd. and Biogen Inc. announced today that Eisai has submitted a Marketing Authorization Application (MAA) for lecanemab, an investigational anti-amyloid beta (Aβ) protofibril antibody, for the treatment of early Alzheimer's disease (mild cognitive impairment due to Alzheimer's disease (AD) and mild AD dementia) with confirmed amyloid pathology in the brain, to the UK Medicines and Healthcare products Regulatory Agency (MHRA) in Great Britain. more info >> |
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Monday, May 22, 2023 |
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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、英国(北アイルランドを除く)において早期アルツハイマー病に係る販売承認申請を提出 |
エーザイ株式会社とバイオジェン・インクは、このたび、英国(北アイルランドを除く)において、 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)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)に係る販売承認申請(MAA)を、英国医薬品医療製品規制庁(MHRA)に提出したことをお知らせします。 more info >> |
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Wednesday, May 17, 2023 |
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エーザイ、臨床第III相Clarity AD試験データを用いた、日本における「レカネマブ」の社会的価値について、査読学術専門誌Neurology and Therapy誌に掲載 |
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、アルツハイマー病(AD)による軽度認知障害(MCI)および軽度AD(総称して早期ADと定義)当事者様に対する抗アミロイド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「LEQEMBITM」)の日本の医療システム下における社会的価値をシミュレーションした結果が査読学術専門誌Neurology and Therapy誌に掲載されたことをお知らせします。 more info >> |
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Tuesday, May 16, 2023 |
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Health Canada Accepts New Drug Submission for Lecanemab as Treatment for Early Alzheimer's Disease |
Eisai Co., Ltd. and Biogen Inc. announced today that Health Canada has accepted a New Drug Submission (NDS) for lecanemab (brand name in the U.S.: LEQEMBI), an investigational anti-amyloid beta (Abeta) protofibril* antibody, for the treatment of early Alzheimer's disease (mild cognitive impairment due to Alzheimer's disease (AD) and mild AD dementia) with confirmed amyloid pathology in the brain. more info >> |
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Monday, May 8, 2023 |
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Eisai Enters Into Joint Development Agreement with Blissbio for Antibody Drug Conjugate BB-1701 with Option Rights for Strategic Collaboration |
Eisai Co., Ltd. announced today that it has entered into a joint development agreement with Bliss Biopharmaceutical (Hangzhou) Co., Ltd., for BB-1701, an antibody-drug conjugate (ADC) with option rights for a strategic collaboration. more info >> |
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エーザイ、抗体薬物複合体BB-1701について、BlissBioと戦略的提携に向けたオプション権を有する共同開発契約を締結 |
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、抗体薬物複合体(Antibody-Drug Conjugate:ADC)である BB-1701 について、Bliss Biopharmaceutical(Hangzhou) Co., Ltd.(本社:中国浙江省、以下 BlissBio)と戦略的提携に向けたオプション権を有する共同開発契約を締結したことをお知らせします。 more info >> |
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Thursday, April 6, 2023 |
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Eisai Completes a Major Renovation of Tsukuba Research Laboratories |
Eisai Co., Ltd. today announced the completion of a major renovation of its Tsukuba Research Laboratories (Ibaraki, Japan), which is a part of strategic investment to execute Eisai's medium-term business plan "EWAY Future & Beyond". more info >> |
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エーザイ、筑波研究所の大規模改修工事が竣工 |
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実施した筑波研究所(茨城県)の大規模改修工事が竣工したことをお知らせします。 more info >> |
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Friday, April 23, 2021 |
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Eisai: Gilead Sciences Submits New Drug Application in Japan for Filgotinib for the Treatment of Ulcerative Colitis with an Inadequate Response to Conventional Therapies |
Gilead Sciences K.K. and Eisai Co., Ltd. today announced that Gilead submitted an application to Japan's Pharmaceuticals and Medical Devices Agency (PMDA) for approval of filgotinib for an additional indication to treat patients with moderately to severely active ulcerative colitis. more info >> |
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エーザイ、アデュカヌマブのブラジル・カナダ・オーストラリア・スイスにおける販売承認申請の提出について |
エーザイ株式会社(本社:東京都、代表執行役CEO:内藤晴夫)は、アルツハイマー病治療薬候補であるアデュカヌマブについて、バイオジェン(Nasdaq: BIIB)が4月22日(米国東部時間)に発出した2021年第1四半期決算プレスリリースにおいて、既に発表している米国、欧州、日本以外の国々における販売承認申請の状況を公表しましたのでお知らせします。 more info >> |
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