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.
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 Leqembi (lecanemab-irmb) for maintenance dosing once every four weeks for the early stages of Alzheimer's disease.
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 ...
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 ...
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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 ...
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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 ...
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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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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.
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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 ...
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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 ...