Biogen, EMA and FDA

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.
FDA and EMA review Biogen's higher dose SMA drug
CAMBRIDGE, Mass. - Biogen Inc. (NASDAQ:BIIB), a $20.8 billion biotechnology company with a robust 75.6% gross profit margin, has reached a pivotal phase as regulatory agencies in the United States and Europe are now reviewing a higher dose regimen of nusinersen,
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,
Biogen Gets U.S., European Reviews of Higher-Dose Spinraza
Biogen said the U.S. Food and Drug Administration has accepted its supplemental new-drug application, while the European Medicines Agency has validated its application, which confirms that the submission is complete and starts the EMA's centralized review process.
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.
Biogen Says FDA And EMA Accept Applications For Higher Dose Regimen Of Nusinersen In SMA
Biogen Inc. (BIIB) announced Thursday that the U.S. Food and Drug Administration (FDA) has accepted the company's supplemental New
FierceBiotech1d
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 ...
FiercePharma2d
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 ...
BioSpace2d
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 ...
BioPharma Dive10d
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 ...
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, ...
STAT10d
Biogen CEO confirms he’s shopping for biotechs: ‘We will be doing deals’
Biogen is looking to augment growth by hunting for biotechs with drugs in mid- and late-stage clinical development.
BioWorld2d
Sage lawsuit enforces standstill as board evaluates Biogen offer
A series of disappointments that drove Sage Therapeutics Inc.’s stock down by 85% since August of 2023 has evolved into an unsolicited takeout offer by partner Biogen Inc., followed by a lawsuit filed ...
Biogen Inc. stock outperforms competitors on strong trading day
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