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Biogen update on efficacy of nusinersen

  • 26 February 2017

In infants with spinal muscular atrophy (SMA), treatment with Spinraza (nusinersen), the first FDA-approved drug for SMA, reduces the risk of death or permanent ventilation, according to new results from the Phase 3 ENDEAR study (NCT02193074).

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European procedure for registration of medicines

  • 20 February 2017

The evaluation of medicines in the EU can be through single national submissions (in the first instance then a mutual review lead by the country who made the first assessment) but in the case of medicines of high importance like…

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