Spinraza remains a big product for Biogen, but has seen its sales go into reverse as competition in SMA treatment has emerged ...

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 ...

Biogen said U.S. and European regulators will review its applications seeking approval of a higher-dose regimen of its Spinraza drug for the neuromuscular disease 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 ...

Biogen’s applications for the higher dose regimen of SMA drug Spinraza are now under review in the US and Europe.

Notably, the incidence of serious adverse events was lower in the higher dose group at 60%, compared to the 72% incidence seen in the 12mg group. Spinraza – approved in the US in 2016 and Europe ...