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 regulator backs Eisai-Biogen Alzheimer's drug after initial rejection
The European Union's drugs regulator on Thursday recommended approval for Eisai and Biogen's Leqembi in some patients with early Alzheimer's disease, nearly four months after it 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.
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.
European regulators green light new Alzheimer's drug after first rejecting it
European regulators initially said in July that the drug's benefits did not outweigh its risks. View on euronews
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.
Biogen raises 2024 outlook on strong Alzheimer's drug sales
Biogen Inc. is now projecting a better-than-expected 2024 as the company continues to see an uptick in sales from Leqembi, ...
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 ...
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Biogen Inc.
Biogen, Inc. is a biopharmaceutical company, which engages in discovering, developing, and delivering therapies for neurological and neurodegenerative diseases. Its products include TECFIDERA ...
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Biogen Enters Oversold Territory (BIIB)
A stock is considered to be oversold if the RSI reading falls below 30. In trading on Monday, shares of Biogen Inc (Symbol: BIIB) entered into oversold territory, hitting an RSI reading of 29.8 ...
Biogen Raises Forecast as Alzheimer’s Drug Leqembi Shows Signs of Growth
Biogen Inc. raised its annual earnings guidance after reporting better-than-expected third-quarter sales and profit, driven ...
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Biogen Plunges as Alzheimer Drug’s Slow Uptake Signals Reset
(Bloomberg) -- Biogen Inc. fell the most in two years as its latest foray into Alzheimer’s disease got off to a slow start, suggesting a long road to growth for the biotechnology giant.
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Biogen's Q3 2024 Earnings: What to Expect
Biogen experienced challenges in its stock ... of the author and do not necessarily reflect those of Nasdaq, Inc. With headquarters in the heart of Chicago's financial district, Barchart has ...
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Lawsuit Alleging $23 Million Contract Breach Against Biogen Moves Forward
Acting Manhattan Supreme Court Justice Anar Rathod Patel last week denied a motion to dismiss from defendants Reata and Biogen, finding that fact questions remained. A New York judge has cleared ...
Eisai Receives Positive Opinion from the CHMP in the European Union for Lecanemab in Early Alzheimer’s Disease
1. About lecanemab (generic name, brand name: Leqembi®) Lecanemab is the result of a strategic research alliance between Eisai and BioArctic. It is a humanized immunoglobulin gamma 1 (IgG1) monoclonal ...