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Biogen, EU and Eisai
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.
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.
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.
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.
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
1d
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 ...
8d
on MSN
Merck, Eisai's combination drug fails in late-stage trial for esophageal cancer
Merck and Japan-based Eisai said on Friday a combination of their therapies failed to extend the lives of patients with a ...
Hosted on MSN
5d
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 ...
BioSpace
5d
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 ...
FiercePharma
8d
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 MSN
8d
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 ...
devdiscourse
5d
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 ...
FiercePharma
1d
Merck vaccine, Daiichi ADC win approval recommendations in busy week at EU's drug regulator
Several medicines are poised to reach new heights after winning key endorsements from European drug regulators. | Among those ...
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Related topics
Biogen
Leqembi
Alzheimer's disease
Food and Drug Administration
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