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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 & EMA Accept Biogen's Filings for Higher Dose SMA Drug
Biogen BIIB announced that the FDA and EMA have accepted its regulatory filings seeking label expansion for a higher dose of its blockbuster spinal muscular atrophy (SMA) drug Spinraza. This new proposed dosing regimen simplifies administration by offering two initial 50 mg doses spaced 14 days apart,
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,
1d
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 ...
FierceBiotech
3d
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 ...
FiercePharma
4d
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 Dive
12d
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 ...
BioSpace
4d
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 ...
11d
on MSN
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 ...
1d
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 ...
10d
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, ...
FiercePharma
13d
Biogen, already a Sage partner and equity owner, offers to buy the rest of the neuro biotech
A yearslong partner of neuroscience player Sage, Biogen already owns 10.2% of the Cambridge, Massachusetts-based biotech, ...
Pharm Exec
1d
Biogen Seeks FDA Approval for a Higher Dosing Regimen of Spinraza for Spinal Muscular Atrophy
Application is supported by results from the DEVOTE study, which suggested that two doses of Spinraza (nusinerse) 50 mg taken ...
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Related topics
United States
Spinraza
Sage
European Medicines Agency
Food and Drug Administration
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