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Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, ¡°Eisai¡±) and Biogen Inc. (Nasdaq: BIIB, Corporate headquarters: Cambridge, Massachusetts, CEO: Christopher A. Viehbacher, ¡°Biogen¡±) announced today that the humanized amyloid-beta (A¦Â) monoclonal antibody ¡°Leqembi?¡± (brand name, generic name: lecanemab) has been granted a Marketing Authorization by the Medicines and Healthcare products Regulatory Agency (MHRA) in Great […]

Eisai and Biogen announced today that the Ministry of Health and Prevention in the United Arab Emirates (UAE) has approved humanized anti-soluble aggregated amyloid-beta (A¦Â) monoclonal antibody ¡°LEQEMBI?¡± (lecanemab) for the treatment of Alzheimer¡¯s disease (AD).

Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, ¡°Eisai¡±) reconfirmed today that the regulatory
status for anti-amyloid beta (A¦Â) protofibril antibody LEQEMBI? (generic name: lecanemab) subcutaneous
(SC) autoinjector, explained at the Financial Disclosure Meeting on August 2, 2024, is as follows.

Eisai Co., Ltd. announced today that the company has entered into a license agreement regarding the development and commercialization rights for the antifungal agent fosravuconazole in the Asia/Oceania region with Sato Pharmaceutical Co., Ltd.

Eisai and Biogen announced today that the Ministry of Food and Drug Safety
(MFDS) in South Korea has approved humanized anti-soluble aggregated amyloid-beta (A¦Â)
monoclonal antibody ¡°LEQEMBI?¡± (lecanemab) for treatment in adult patients with mild cognitive
impairment due to Alzheimer¡¯s disease (AD) or mild AD (early AD).

Eisai and Biogen announced today that Eisai has initiated the rolling submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for lecanemab-irmb (U.S. brand name: LEQEMBI?) subcutaneous autoinjector for weekly maintenance dosing after it was granted Fast Track designation by the FDA.

Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, ¡°Eisai¡±) announced today that the injection formulation of its in-house discovered antiepileptic drug (AED) Fycompa? (perampanel hydrate) for intravenous (IV) infusion has been launched in Japan.

Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, ¡°Eisai¡±) announced today that drug discovery research conducted on lemborexant (brand name: Dayvigo?), the dual orexin receptor antagonist discovered by Eisai, has been honored with The Pharmaceutical Society of Japan (PSJ) Award for Drug Research and Development 2024 by the PSJ.

Eisai Co., Ltd. announced on Jan 26 that it has submitted a New Drug Applicationfor ultrahigh-dose mecobalamin (development code: E0302) for the indication of amyotrophic lateral sclerosis (ALS) to the Pharmaceuticals and Medical Devices Agency in Japan.

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