Biogen, Spinraza and European Medicines Agency

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 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 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.
FDA and EMA Accept Applications for Higher Dose Regimen of Nusinersen in SMA
We are pleased to announce that our applications for the higher dose regimen of nusinersen are now under review in the US and Europe,” said Stephanie Fradette, Pharm.D., Head of the Neuromuscular Development Unit at Biogen.
US, EU regulators to review higher-dose Spinraza for use in SMA
Regulators in the U.S. and the European Union agreed to review Biogen’s applications for approval of a higher dose Spinraza regimen for SMA.
US/EU regulators start review of Biogen's high-dose Spinraza
Spinraza remains a big product for Biogen, but has seen its sales go into reverse as competition in SMA treatment has emerged from Evrysdi (risdiplam), which was approved by the FDA in 2020 and can be delivered orally, as well as Novartis' blockbuster gene therapy Zolgensma, which got a green light in 2019.
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
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,
Pharm Exec2d
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 ...
Hosted on MSN3d
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 ...
FiercePharma4d
Regulatory tracker: Biogen's high-dose Spinraza under review at FDA, EMA
The high-dose Spinraza is Biogen's answer to competitors such as Novartis' gene therapy Zolgensma. Xifaxan is one of 15 drugs up for the second cycle of Medicare price negotiations under the ...
pharmaphorum3d
Biogen looks beyond Spinraza in SMA with Ionis deal
Spinal muscular atrophy (SMA) therapy Spinraza has been a key earner for Biogen in recent years, but with sales now heading into reverse, the company is looking to extend its franchise.
Nasdaq1mon
Biogen Stock Declines 21.4% in 3 Months: How to Play the Stock
Sales of Biogen’s key multiple sclerosis (“MS”) drugs like Tecfidera and Tysabri and spinal muscular atrophy (SMA) treatment, Spinraza are declining due to competitive pressure. Biogen has ...
SMA5d
Woman gives birth to healthy child while on Spinraza treatment
A woman with SMA type 3 became pregnant while on Spinraza treatment and gave birth to a healthy child, per a case report.