Biogen has exercised its option to develop and commercialize nusinersen following positive interim Phase III results, agreeing to advance the spinal muscular atrophy (SMA) candidate in a deal that ...

A trial of Biogen’s spinal muscular atrophy (SMA) therapy Spinraza (nusinersen) suggests that a higher dose provides benefits to a broad range of patients—including those who have and have not ...

Biogen Inc. announced that the FDA has accepted and the EMA has validated its supplemental New Drug Application for a higher dose regimen of nusinersen, intended for treating spinal muscular ...

Biogen intends to market nusinersen under the brand name SPINRAZA TM. This name has been conditionally accepted by the FDA and the CHMP and will be confirmed upon approval. ...

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 Inc. (Nasdaq: BIIB) today announced that The National Institute for Health and Care Excellence (NICE) in the United Kingdom has recommended funding for SPINRAZA (nusinersen) on the National ...

As a result, Biogen will exercise its option to develop and commercialize the treatment, known as nusinersen, and paid Ionis a $75 million licensing fee. Biogen also plans to submit regulatory ...

Cost-effectiveness body NICE has rejected Biogen’s Spinraza (nusinersen) therapy for the rare genetic muscle wasting disease spinal muscular atrophy (SMA) because of its high cost – but is in ...

FY24 EPS is projected at $16.34. The FDA approved maintenance dosing regimen for Leqembi in Alzheimer's, while Biogen's nusinersen higher-dose regimen is under review. Unlock your all-in-one ...

Treatment with nusinersen was linked to increased motor ... Proud reports serving on advisory boards and as a consultant for AveXis, Biogen, and Sarepta; serving as a speaker for AveXis and ...