Biogen, Alzheimer's and Eisai

Biogen’s stock rises after E.U. regulator reverses negative view of Alzheimer’s drug
Biogen’s stock rose 1% Thursday, after Europe’s pharmaceutical regulator issued a positive opinion on the Alzheimer’s disease drug that the company developed with Japanese partner Eisai — reversing an earlier decision not to approve the drug.
EU regulator backs Eisai-Biogen Alzheimer's drug after initial rejection
The European Union's drugs regulator on Thursday recommended approval of Eisai and Biogen's Leqembi for some patients with early Alzheimer's disease, reversing its initial decision from four months ago.
EMA changes tune, endorses Eisai and Biogen's Leqembi in restricted Alzheimer's population
Upon reexamination, the European Medicines Agency has made a U-turn on Eisai and Biogen’s Alzheimer’s disease drug Leqembi. | Upon reexamination, the EMA has made a U-turn on Eisai and Biogen’s Alzheimer’s disease drug Leqembi.
EMA's CHMP Now Recommends Approval for Eisai, Biogen's Alzheimer's Drug Leqembi in Europe
The agency had previously recommended against marketing authorization for the Alzheimer's disease but reconsidered after a review.
European Committee Takes a Second Look at Alzheimer's Drug and Now Says It Should Be Approved
A European regulatory committee now recommends approval of the Alzheimer’s treatment lecanemab a few months after rejecting the drug
EU drugs regulator recommends Alzheimer's drug from Eisai-Biogen
The European Union's drugs regulator on Thursday said it recommends approval of Eisai and Biogen's Leqembi in patients with early Alzheimer's disease, months after the agency first rejected the treatment.
EU regulator reverses decision to block Alzheimer's drug lecanemab
The European Union's drugs regulator reversed its decision to block the Alzheimer's drug lecanemab, a treatment aimed at slowing cognitive decline in patients. In July, the Amsterdam-based European Medicines Agency (EMA) denied recommending approval of the drug made by Eisai and Biogen because it considered the risks - especially bleeding and swelling in the brain - to be greater than the potential benefits in a broad population.
European Watchdog Partially Approves New Alzheimer's Drug
Europe's medicines watchdog on Thursday partially approved a marketing request for a long-awaited new treatment for Alzheimer's disease, reversing an earlier decision not to give it the green light.
Changing course, European regulators now say Alzheimer’s treatment Leqembi should be approved
Reversing an earlier decision, European regulators recommended that an Alzheimer’s therapy from Eisai and Biogen should be approved.
Ticker: Biogen Alzheimer’s drug gets second look in EU; Ford takes $165M hit on slow recall
A European regulatory committee now recommends approval of the Alzheimer’s treatment lecanemab a few months after rejecting ...
Biogen up 5% after EMA recommends Leqembi for early Alzheimer’s disease
EST Biogen (BIIB) up 5% after EMA recommends Leqembi for early Alzheimer’s disease Published first on TheFly – the ultimate ...
BioSpace1d
5 Reasons Biogen’s Shares Have Dropped 36% in 2024
A slow launch for Alzheimer's medicine Leqembi, a lackluster pipeline and a challenging drug launch environment are just a ...
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Biogen Inc. stock underperforms Wednesday when compared to competitors
Shares of Biogen Inc. BIIB slid 1.48% to $165.79 Wednesday, on what proved to be an all-around favorable trading session ...
Business Insider13h
Raymond James sees EU Leqembi uptake as more modest for Biogen than in U.S.
With a narrow label, the firm believes uptake in the EU will be “(even) more modest than what we’ve seen in the U.S.,” adds the analyst, who reiterates a Market Perform rating on Biogen (BIIB) ...
Biogen lifts annual profit forecast as new treatments boost earnings
Biogen raised its annual profit forecast on Wednesday, as new treatments and cost-cutting measures offset declining sales of ...
The Pharma Letter2d
UCB and Biogen’s dapirolizumab pegol paves new path for SLE treatment
Belgian drugmaker UCB and US biotech Biogen’s Phase III PHOENYCS GO trial results signal a pivotal development for systemic lupus erythematosus (SLE) treatment, as dapirolizumab pegol met its primary ...
MM&M13d
Rx Rundown: AbbVie, Biogen, GSK and more
GSK acquired an experimental therapy from Chimagen Biosciences, paying $300 million upfront for the “T-cell engager” therapy, ...
Business Insider1d
Biogen initiated with a Neutral at Citi
Citi analyst Geoff Meacham initiated coverage of Biogen (BIIB) with a Neutral rating and $190 price target The company’s strategy to offset core franchise erosion has been to develop assets with ...