Eisai, Biogen and Alzheimer's

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 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
U.S. 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 approved for continuous use for people with early stages of the disease by U.
Biogen Trims Research Workforce, Higher-Dose SMA Drug Accepted for Regulatory Review
In a good-news-bad-news week for Biogen, the company will cut an undisclosed number of employees, just as a higher dose of its Ionis-partnered therapy Spinraza for spinal muscular atrophy will be considered by the FDA and EMA.
Biogen lays out three FDA decisions that could ramp up Alzheimer's drug launch
Since its approval in 2023, the Alzheimer's disease drug made by Biogen Inc. and Eisai has seen a lackluster launch. However, Biogen CEO Chris Viehbacher said on Tuesday that there are a “number of catalysts” that could accelerate Leqembi’s growth in 2025.
USFDA nod to Leqembi IV maintenance dosing for treatment of early Alzheimer's Disease: Eisai, Biogen
Tokyo: Eisai Co., Ltd. and Biogen Inc. have announced that the U.S. Food and Drug Administration (FDA) has approved the Supplemental Biologics License Application (sBLA) for once every four
FDA Approves Once-Every-Four-Weeks Maintenance Dosing Of LEQEMBI For Early Alzheimer's Disease
Eisai Co., Ltd. (ESALF.PK) and Biogen Inc. (BIIB) announced Sunday that the U.S. Food and Drug Administration has approved the
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 ...
FierceBiotech4d
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 ...
BioPharma Dive13d
Biogen’s ‘cold and calculated’ offer to buy Sage receives a mixed reaction on Wall Street
Analysts say the deal, which would give Biogen full control over the drug Zurzuvae, could be a smart financial move. Yet it's ...
BioSpace5d
Sage Sues Partner Biogen After Unsolicited Takeover Offer
Biogen’s effort to buy Sage reveals its “desire to expand its pipeline at a discount,” according to analysts from BMO Capital ...
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 ...
Biogen announces FDA, EMA accepted applications for higher dose of nusinersen
Biogen (BIIB) announced that the U.S. Food and Drug Administration, FDA, has accepted the company’s supplemental New Drug Application, sNDA, ...