Biogen, Eisai and Alzheimer's

Biogen/Eisai’s Alzheimer’s drug approved by FDA for monthly maintenance dosing
Biogen and Eisai’s Alzheimer’s disease (AD) drug Leqembi (lecanemab-irmb) has been approved by the US Food and Drug Administration (FDA) for monthly maintenance dosing. The anti-amyloid drug was granted traditional approval in the US in July 2023 for use as an intravenous (IV) infusion in patients with mild cognitive impairment or early-stage AD.
Eisai and Biogen’s LEQEMBI sBLA set for Alzheimer’s maintenance dosing
The FDA has approved the sBLA of Eisai and Biogen's LEQEMBI for maintenance dosing indicated for the early stages of Alzheimer's.
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.
US regulator OKs Eisai-Biogen Alzheimer's drug's continuous dosing
Japanese pharmaceutical company Eisai Co. and U.S. firm Biogen Inc. said Monday that a jointly developed Alzheimer's drug has been ap
FDA approves Eisai, Biogen’s sBLA for lecanemab-irmb IV dosing
Eisai (ESAIY) and Biogen (BIIB) announced that the U.S. Food and Drug Administration, FDA, has approved the Supplemental Biologics License
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.
This Week in Chancery Court: Biogen, T-Mobile, Repsol SA
Biogen Inc. is fending off a lawsuit in the Delaware Chancery Court over its recent offer to buy out Sage Therapeutics, its ...
Wedbush Forecasts Biogen’s FY2024 Earnings (NASDAQ:BIIB)
Equities research analysts at Wedbush dropped their FY2024 EPS estimates for Biogen in a research report issued on Thursday, ...
Biogen CEO tells Governor Healey he’s concerned about ‘a lot more policy risk’ in D.C.
Chris Viehbacher spoke out about the uncertain policy environment for life sciences companies, though he didn't single ...
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Biogen research team hit by layoffs as company shifts resources to external opportunities
Biogen has been in the news recently after longtime partner Sage Therapeutics filed a lawsuit against the company after ...
FiercePharma5d
Sage sues Biogen as analyst detects little interest in buyout at original offer price
Sage Therapeutics has brought a lawsuit against Biogen shortly after receiving an “unsolicited” offer from its neuroscience ...
Biogen CEO sees no burning need for more acquisitions
Biogen expects revenue from new launches to exceed its current sales by 2028 and does not feel the need to chase additional ...
Biogen Inc. stock outperforms competitors on strong trading day
Supported by world-class markets data from Dow Jones and FactSet, and partnering with Automated Insights, MarketWatch ...
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Biogen’s higher dose Spinraza under review by US and EU regulators
Biogen’s applications for the higher dose regimen of SMA drug Spinraza are now under review in the US and Europe.