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.
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.
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
Update on Regulatory Review of Lecanemab for Early Alzheimer's Disease in the European Union
Lecanemab is the result of a strategic research alliance between Eisai and BioArctic. It is a humanized immunoglobulin gamma 1 (IgG1) monoclonal antibody directed against aggregated soluble (protofibril) and insoluble forms of amyloid-beta (Aβ).
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
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 ...
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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 ...
BioArctic stock sinks on EU regulatory concerns
Shares of BioArctic AB tumbled by 7% on Friday following news that the European Commission (EC) has requested further review of the company's Alzheimer's drug, lecanemab, by the Committee for ...
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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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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 ...
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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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MRK Reports Mixed Keytruda Combo Study Data in Gastroesophageal Cancer
Merck MRK along with partner Eisai announced data from the phase III LEAP-015 study, which evaluated blockbuster PD-1 ...
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FDA Approves LEQEMBI® (lecanemab-irmb) IV Maintenance Dosing for the Treatment of Early Alzheimer's Disease
Once every four weeks maintenance dosing may be easier for patients and care partners to continue treatment   TOKYO and CAMBRIDGE, Mass., Jan. 26, 2025 /PRNewswire/ -- Eisai Co., Ltd. (Headquarters: ...