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(2) Pratteln, Switzerland, March 3, 2021 - Santhera Pharmaceuticals (SIX: SANN) announces that the last patient has completed the last visit for the first period of the placebo-controlled pivotal VISION-DMD study with vamorolone in patients with Duchenne muscular dystrophy (DMD), conducted by partner ReveraGen Biopharma Inc. Subject to a positive 6-month topline data readout of this first study phase, this could allow for a regulatory submission to the US FDA in Q1-2022 with the potential to offer an alternative to current standard of care in DMD. The 48-week Phase 2b VISION-DMD study is designed as a pivotal trial to demonstrate efficacy and safety of vamorolone administered orally at doses of 2.0 mg/kg/day and 6.0 mg/kg/day versus prednisone 0.75 mg/kg/day and placebo in ambulant boys aged 4 to

Switzerland generalUnited statesUnited kingdomEric hoffmanEva kaliasReveragen biopharmaDario eklundReveragen biopharma incSanthera pharmaceuticalsMuscular dystrophy association united statesNational institutes of healthHead external communicationsEuropean commission horizonDuchenne research fundFoundation to eradicate duchenneSanthera pharmaceuticals holding