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.
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.
Biogen, Eisai Alzheimer’s drug review delayed in EU
Biogen (BIIB) stock in focus as company and partner Eisai (ESALF) face delay in the EU launch of Alzheimer's drug lecanemab. Read more here.
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.
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
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 ...
pharmaphorum1h
EMA experts will look again at Leqembi's safety data
In the latest development, the European Commission has asked the EMA's human medicines committee, the CHMP, to take a look at ...
Merck and Eisai's cancer drugs fail to improve overall survival in late-stage trial
Merck's blockbuster drug Keytruda and Eisai's cancer drug Lenvima, in combination with chemotherapy, failed to improve ...
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 ...
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 ...
FiercePharma7d
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 ...
GlobalData on MSN6d
MSD and Eisai’s LEAP gastroesophageal cancer trial sees mixed success
MSD and Eisai’s trial saw mixed success with its two primary endpoints, seeing success in progression-free survival, but ...
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Health News Highlights: Breakthroughs, Rejections, and Strategies
In recent health developments, Akero Therapeutics' drug shows promise for liver disease, Eisai/Biogen's Alzheimer's drug ...