Biogen, Eisai and Leqembi

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, 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 patients with Alzheimer’s, could help with Leqembi’s thus far disappointing uptake and sales.
Biogen, Eisai Get FDA Nod for Leqembi IV Maintenance Dosing
Biogen and Eisai have won Food and Drug Administration approval of an intravenous maintenance dosing of their Leqembi drug for early Alzheimer's disease. The companies late Sunday said the FDA approved the maintenance dosing of once every four weeks after 18 months of the initiation phase of once every two weeks.
BIIB Secures FDA Nod for Monthly Maintenance Dosing of Alzheimer's Drug
The FDA's approval is based on simulation data from multiple studies showing that maintenance dosing with Biogen???s Leqembi every four weeks prolongs biomarker benefits.
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 treatmentAlzheimer's disease progression does
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.
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. The drug received standard U.
FDA clears monthly dosing of Alzheimer’s drug Leqembi
The approval is the first to come from the FDA since the Trump administration paused external communication by health agencies last week.
Biogen's SWOT analysis: neurology giant faces pipeline hurdles, stock outlook mixed
Biogen Inc. (NASDAQ:BIIB), a leading biopharmaceutical company specializing in neurology and rare diseases, finds itself at a critical juncture as it navigates a complex landscape of opportunities and ...
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U.S. health agencies see some chaos — but an FDA approval gets through
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Biogen Trims Research Workforce, Higher-Dose SMA Drug Accepted for Regulatory Review
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From Drug Approvals to Global Health Funding: Key Updates in Health Sector
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