News - Biogen
Biogen News Releases and Company Statements. Eisai Completes Rolling Submission to US FDA for LEQEMBI® (lecanemab-irmb) Biologics License Application for Subcutaneous Maintenance Dosing for the Treatment of Early Alzheimer’s Disease Under the Fast Track Status.
Biogen Announces Positive Topline Results from Study of Higher …
Sep 4, 2024 · Positive study demonstrates the potential for investigational higher dose nusinersen regimen to advance the treatment of SMA; Biogen plans to submit for regulatory approval of this investigational dose regimen; Higher dose nusinersen regimen showed statistically significant improvement compared to a prespecified matched sham control group
Biogen to Realign Resources for Alzheimer's Disease Franchise
CAMBRIDGE, Mass., Jan. 31, 2024 (GLOBE NEWSWIRE) -- Biogen Inc. (Nasdaq: BIIB) today announced plans to reprioritize its resources in Alzheimer’s disease (AD), a strategic therapeutic area expected to drive near and long-term growth.
Biogen Raises Forecast as Alzheimer’s Drug Leqembi Shows Signs …
Oct 30, 2024 · (Bloomberg) -- Biogen Inc. raised its annual earnings guidance after reporting better-than-expected third-quarter sales and profit, driven by ongoing cost-cutting measures and the strong performance of its new Alzheimer’s treatment.
FDA Approves Biogen’s Drug for Rare Form of ALS - The New York Times
Apr 25, 2023 · The Food and Drug Administration on Tuesday authorized the first drug for a rare genetic form of the neurological disorder A.L.S., despite uncertainty about the treatment’s effectiveness.
Biogen discontinues Alzheimer’s medication Aduhelm - CNN
Jan 31, 2024 · CNN — The Alzheimer’s medication Aduhelm is being discontinued by drugmaker Biogen as it shifts resources to its other Alzheimer’s medication, Leqembi, and developing other treatments, the...
Biogen Gains Momentum With Positive Lupus Drug Results, …
3 days ago · BIIB. UCBJY. Biogen Gains Momentum With Positive Lupus Drug Results, Analyst Sees Modest Valuation Upside. On Tuesday, UCB SA (OTC: UCBJY) (OTC: UCBJF) and Biogen Inc. (NASDAQ: BIIB) presented ...
Samsung Bioepis, Biogen Get European Commission ... - Markets …
5 days ago · (RTTNews) - Samsung Bioepis Co., Ltd. and Biogen Inc. (BIIB) Monday announced that the European Commission (EC) has approved Opuviz, a biosimilar to Regeneron Pharmaceuticals' Aflibercept. Opuviz ...
Biogen in up to $1.8 bln deal as rare diseases take center stage
May 22 (Reuters) - Biogen (BIIB.O) said on Wednesday it had agreed to buy privately held Human Immunology Biosciences for up to $1.8 billion, bulking up on rare disease medicines as its...
US FDA grants standard approval of Eisai/Biogen Alzheimer's drug
LOS ANGELES, July 6 (Reuters) - Eisai (4523.T) and Biogen's (BIIB.O) Leqembi won a coveted standard approval nod from the U.S. Food and Drug Administration on Thursday, the first...