eisai - Search News

Biogen, EU and Eisai

EU to Weigh New Safety Data on Biogen, Eisai Alzheimer’s Drug

European Union regulators will review new information relating to the safety of Eisai Co.’s and Biogen Inc.’s medicine for Alzheimer’s disease, providing a response after a meeting next month.

Reuters · 2h

Europe to review safety data for Eisai-Biogen Alzheimer's drug

The European Commission has requested its medicines regulator to consider safety information on Eisai and Biogen's Alzheimer's drug Leqembi, the agency said on Friday.

Seeking Alpha on MSN · 1h

Biogen, Eisai Alzheimer’s drug review delayed in EU

Biogen (NASDAQ:BIIB) and Eisai (OTCPK:ESALF) are expected to face another delay in launching their new Alzheimer's drug, lecanemab, in the EU after the European Commission on Friday asked the region's drug regulator to reconsider a prior decision that endorsed the anti-amyloid therapy.

YAHOO!Finance · 2h

Update on Regulatory Review of Lecanemab for Early Alzheimer’s Disease in the European Union

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 an update on the ongoing regulatory review of the Marketing Authorization Application for lecanemab as treatment for early AD (mild cognitive impairment due to Alzheimer’s disease (AD) and mild AD) in the European Union.

Reuters · 3d

US FDA OKs monthly maintenance dosing for Eisai/Biogen's Alzheimer's drug

The U.S. Food and Drug Administration has approved monthly maintenance dosing for Japan's Eisai and partner Biogen's Alzheimer's drug Leqembi, the companies said on Monday.

Business Insider · 1h

Biogen provides update on EU regulatory review of lecanemab in Alzheimer’s

Biogen (BIIB) and Eisai announced an update on the ongoing regulatory review of the Marketing Authorization Application for lecanemab as

YAHOO!Finance · 1h

Update on regulatory review of lecanemab for treatment of early Alzheimer's disease in the European Union

BioArctic AB's (publ) (Nasdaq Stockholm: BIOA B) partner Eisai today announced that the European Commission has asked the Committee for Medicinal Products for Human Use (CHMP) to consider two additional questions.

Biogen, Eisai: EC Asks CHMP to Take Another Look at Leqembi

Biogen and Eisai said they believe that EC's requests can be addressed with existing information, and that no new safety signals have been identified for Leqembi. The U.S. Food and Drug Administration ...

Hosted on MSN3d

Eisai and Biogen’s Leqembi sBLA set for Alzheimer’s maintenance dosing

The US Food and Drug Administration has approved the supplemental biologics licence application (sBLA) of Eisai and Biogen's ...

FiercePharma6d

Merck, Eisai's star-crossed Keytruda-Lenvima combo misses survival goal in GI cancer trial

Merck & Co. and Eisai have to deal with the reality that yet another phase 3 trial of their combination of Keytruda and ...

BioSpace4d

Biogen, Eisai Win Nod for Monthly Leqembi Maintenance Amid Stagnant Sales

The monthly maintenance regimen, which offers a more convenient frequency than the initially approved treatment schedule for ...

MM&M3d

Biogen, Eisai receive FDA nod for monthly Leqembi IV maintenance dosing

The Japanese and American based pharma companies announced a win for their Alzheimer’s treatment, which has faced some negative backlash over the last year.