Sarepta: FDA finds ‘no significant safety issues of concern’ with DMD gene therapy 06-Mar-2023 By Jane Byrne Sarepta Therapeutics would seem to be edging closer to accelerated FDA approval of its gene therapy for Duchenne muscular dystrophy (DMD).
Catalent made primary commercial manufacturing partner for Sarepta’s DMD gene therapy candidate 10-Jan-2023 By Jane Byrne Catalent is to support the manufacture of Sarepta Therapeutics' gene therapy candidate for the treatment of Duchenne muscular dystrophy (DMD).
Sarepta licenses therapy to boost gene therapies 06-Jul-2020 By Ben Hargreaves Sarepta signs agreement with Hansa to use its treatment as part of a gene therapy treatment schedule.
Dyno launches with gene therapy partnership alongside Novartis 11-May-2020 By Ben Hargreaves The biotech emerges from stealth mode with two partnerships potentially worth in excess of $2bn.
Further safety issues lead to clinical hold for DMD gene therapy 13-Nov-2019 By Ben Hargreaves Solid Biosciences announces that its gene therapy for DMD has been placed under clinical hold again, after a patient experienced a serious adverse event.
US FDA puts gene-therapy on hold after DNA fragment found in plasmids 27-Jul-2018 By Maggie Lynch Sarepta’s gene therapy clinical trial is put on hold by the US FDA after DNA fragment was found in plasmids during quality assurance testing.
