|
| Wednesday, January 15, 2025 |
|
|
FDA Accepts LEQEMBI (lecanemab-irmb) Biologics License Application for Subcutaneous Maintenance Dosing for the Treatment of Early Alzheimer's Disease |
| Eisai Co., Ltd. and Biogen Inc. announced today that the U.S. Food and Drug Administration (FDA) has accepted Eisai's Biologics License Application (BLA) for lecanemab-irmb (U.S. brand name: LEQEMBI) subcutaneous autoinjector (SC-AI) for weekly maintenance dosing. more info >> |
|
| Tuesday, January 14, 2025 |
|
|
エーザイとバイオジェン・インク、早期アルツハイマー病治療剤「レケンビ(R)」の皮下注射製剤維持投与に関する 生物製剤承認申請を米国FDAが受理 |
| 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、ヒト化抗ヒト可溶性アミロイド β（Aβ）凝集体モノクローナル抗体「レケンビ(R)」（一般名：レカネマブ）について、皮下注射オートインジェクター（SC-AI）による維持投与（週一回投与）に関する生物製剤承認申請（BLA）が、米国食品医薬品局（FDA）に受理されたことをお知らせします。 more info >> |
|
| Tuesday, January 7, 2025 |
|
|
Elucidation of part of the Mechanism by which Lecanemab Slows the Progression of Alzheimer's Disease |
| A collaborative research group led by Professor Kenjiro Ono of the Institute of Medical, Pharmaceutical and Health Sciences, Kanazawa University, and Eisai Co., Ltd. more info >> |
|
|
金沢大とエーザイ、レカネマブがアルツハイマー病の病態進行を抑制するメカニズムの一端を解明 |
| more info >> |
|
| Monday, December 23, 2024 |
|
|
Fujirebio and Eisai Enter into Memorandum of Understanding for Joint Research and Social Implementation of Blood-based Biomarkers in the Field of Neurodegenerative Diseases |
| Fujirebio Holdings, Inc., a wholly-owned subsidiary of H.U. Group Holdings, Inc., and Eisai Co., Ltd. announced today that they have entered into a memorandum of understanding for the joint research and social implementation of novel blood-based biomarkers in the field of neurodegenerative diseases. more info >> |
|
| Wednesday, December 11, 2024 |
|
|
Eisai's "URECE(R)" (Dotinurad) Approved in China for Gout Patients with Hyperuricemia |
| Eisai Co., Ltd. announced today that it has received approval for "URECE(R)" (generic name: dotinurad) from the National Medical Products Administration in China as a treatment for gout patients with hyperuricemia. more info >> |
|
| Thursday, December 5, 2024 |
|
|
"LEQEMBI" (Lecanemab) Approved for the Treatment of Early Alzheimer's Disease in Mexico |
| Eisai Co., Ltd. and Biogen Inc. announced today that the Federal Commission forthe Protection Against Sanitary Risk (COFEPRIS) in Mexico has approved humanized anti-soluble aggregated amyloid-beta (Abeta) monoclonal antibody "LEQEMBI" (lecanemab) for the treatment of early Alzheimer's disease (AD). more info >> |
|
| Thursday, November 28, 2024 |
|
|
LEQEMBI (Lecanemab) for the Treatment of Alzheimer's Disease Launched in South Korea |
| Eisai Co., Ltd. and Biogen Inc. announced today that the humanized anti- soluble aggregated amyloid-beta (Abeta) monoclonal antibody "LEQEMBI" has been launched in South Korea. LEQEMBI received the Ministry of Food and Drug Safety (MFDS) approval in May 2024 for treatment in adult patients with mild cognitive impairment due to Alzheimer's disease (AD) or mild AD dementia (early AD). more info >> |
|
| Tuesday, November 26, 2024 |
|
|
Eisai Signs Research Collaboration Agreement with The National Center of Neurology and Psychiatry to Initiate Apolipoprotein E Genetic Testing in the "AD-DMT Registry" in Japan |
| The research will be implemented by the Japan Agency forMedical Research and Development (AMED), with NCNP as the lead research institution. more info >> |
|
| Wednesday, November 20, 2024 |
|
|
Rozebalamin for Injection 25mg (Mecobalamin) for Amyotrophic Lateral Sclerosis Launched in Japan |
| Eisai Co., Ltd. announced today that the amyotrophic lateral sclerosis (ALS) treatment "Rozebalamin for Injection25 mg" (mecobalamin) has been launched in Japan as a treatment for slowing progression of functionalimpairment in amyotrophic lateral sclerosis. more info >> |
|
|
|
|
