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.

A trial studying a higher dose of Biogen’s spinal muscular atrophy (SMA) drug Spinraza (nusinersen) has met the primary endpoint in a cohort of infants with SMA. Data from the Phase II/III ...

Biogen (NASDAQ:BIIB) on Wednesday announced that its Phase 2/3 DEVOTE study reached the primary endpoint for a higher dose of its flagship product, Spinraza, which is approved in the U.S. for the ...

The firm expanded its neurology portfolio beyond MS, including the blockbuster rare neuromuscular disease drug Spinraza. We see Biogen as a firm in transition, as MS revenue fades and launches of ...

Biogen, in a press release. “Prior to receiving Spinraza at the start of RESPOND, we saw that participants had elevated neurofilament levels, as compared to healthy children suggesting ongoing ...

When it comes to spinal muscular atrophy, Biogen and Ionis Pharmaceuticals are two peas in a pod. After the success of Spinraza, the companies have picked another candidate to advance as a ...

Besides Spinraza, Biogen also won coverage for multiple sclerosis ... The complex T-cell one-time therapy reportedly carries a sticker price of 1.2 million yuan ($188,000). During a press ...

Biogen Inc beat first-quarter profit estimates on Thursday as higher-than-expected sales for spinal muscular atrophy treatment Spinraza cushioned the blow from eroding sales of its multiple sclerosis ...

Jan. 08, 2021 (GLOBE NEWSWIRE) — Biogen Inc. (Nasdaq: BIIB) today announced that the first patient has been treated in the global clinical study, RESPOND. The Phase 4 study will examine the clinical ...

Spinraza, a newly approved drug for spinal ... there was finally a treatment for SMA was quickly subsumed by sticker shock. Biogen said it would charge $750,000 per patient for the first year ...

Biogen Inc. BIIB announced that it plans to initiate a global phase IV study on its spinal muscular atrophy (SMA) drug Spinraza (nusinersen). Named RESPOND, the study will evaluate the clinical ...

Biogen's Spinraza, the list price of which drops to $375,000 a year after the first year, was the first approved treatment for spinal muscular atrophy (SMA), a leading genetic cause of infant ...