Thursday, 26 April 2018 - 4:59
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Spinraza

NEJM publishes Phase III results for Biogen/Ionis’ Spinraza

Biogen and Ionis Pharmaceuticals have announced that final results from the Phase III clinical trial ENDEAR, aimed at assessing Spinraza (nusinersen) for the treatment of spinal muscular atrophy (SMA) have been published in the New England Journal of Medicine (NEJM)….

CHMP: OK to Biogen’s Spinraza for SMA

Biogen has announced that EMA CHMP has adopted a positive opinion on Spinraza (nusinersen) for the treatment of SMA (spinal muscular atrophy). The Agency has reviewed the product under its accelerated assessment program, designed to facilitate access to medicines likely…

UnitedHealthcare to cover Biogen/Ionis’ Spinraza

According to an update by UnitedHealthcare, the company will cover Spinraza (nusinersen) for patients with SMA (spinal muscular atrophy) types 1-3, Bloomberg reported. The drug is produced by Biogen and Ionis Pharmaceuticals. The policy specifies that Spinraza should be prescribed…

Biogen’s Spinraza, positive data in SMA

Biogen presented new data from the Phase III ENDEAR study of Spinraza (nusinersen), which demonstrated a significant reduction in the risk of death or permanent ventilation in infants with SMA (spinal muscular atrophy) treated with Spinraza vs the untreated group….

SMA, FDA and EMA accept applications for Biogen’ s nusinersen

Biogen today announced that its https://www.goinpharma.com/nusinersen-biogen-completa-la-domanda-autorizzazione-ad-fda/ (New Drug Application) for nusinersen, an investigational treatment for SMA (spinal muscular atrophy) has been accepted by FDA for Priority Review. At the same time, the MAA (Marketing Authorization Application) for the same product…