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Biogen, SMA

BioSpace · 19h

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.

Hosted on MSN · 20h

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,

GlobalData on MSN · 17h

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.

Business Insider · 21h

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,

MarketWatch · 21h

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.

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 ...

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 ...

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 ...

6don MSN

Sage sues Biogen in wake of $469M buyout offer: report

Sage Therapeutics (NASDAQ:SAGE) is reportedly suing Biogen (NASDAQ:BIIB) over enforcement of a standstill agreement in the ...

20h

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 ...

FiercePharma11d

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, ...

1d

Sage Therapeutics: Looks Like A 'Strong Buy' With Zurzuvae's Potential And Biogen's Bid

Sage Therapeutics has a unique approach to targeting GABA, which allows it to target CNS disorders. Read why I think SAGE ...

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