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 14 days apart can deliver significant clinical benefits in patients with spinal muscular atrophy.
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Biogen’s higher dose Spinraza under review by US and EU regulatorsBiogen’s applications for the higher dose regimen of SMA drug Spinraza are now under review in the US and Europe.
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FDA & EMA Accept Biogen's Filings for Higher Dose SMA DrugBiogen BIIB announced that the FDA and EMA have accepted its regulatory filings seeking label expansion for a higher dose of ...
In a good-news-bad-news week for Biogen, the company will cut an undisclosed number of employees, just as a higher dose of ...
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 ...
Biogen is planning to trial its Spinraza spinal muscular atrophy (SMA) drug in patients who have not responded properly to Novartis' gene therapy Zolgensma, combining the two ultra-expensive ...
Regulators in the U.S. and the European Union agreed to review Biogen’s applications for approval of a higher dose Spinraza ...
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 ...
Spinraza remains a big product for Biogen, but has seen its sales go into reverse as competition in SMA treatment has emerged ...
A woman with SMA type 3 became pregnant while on Spinraza treatment and gave birth to a healthy child, per a case report.
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