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Biogen, EMA and FDA
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 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 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,
Ionis stock rises on FDA, EMA nod for SMA drug dose increase
Shares of Ionis Pharmaceuticals (NASDAQ:IONS) climbed 7% today after the company announced that regulatory agencies in the United States and Europe have accepted applications for a higher dose regimen of its spinal muscular atrophy (SMA) drug,
3h
Biogen CEO tells Governor Healey he’s concerned about ‘a lot more policy risk’ in D.C.
However, the sector faces another kind of risk, with a new administration in charge in Washington.
FierceBiotech
1d
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
3d
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 ...
BioSpace
3d
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 ...
6d
on 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 ...
BioPharma Dive
10d
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 ...
STAT
11d
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.
FiercePharma
11d
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
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 ...
2d
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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Related topics
United States
Nusinersen
Sage Therapeutics
dose regimen
Spinraza
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