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Sarepta

This page shows the latest Sarepta news and features for those working in and with pharma, biotech and healthcare.

Duchenne UK and pharma partner pilot data-sharing HTA approach

Duchenne UK and pharma partner pilot data-sharing HTA approach

The pharma partners - Roche, Sarepta Therapeutics, Solid Biosciences, Summit and Wave Life Sciences - all have an interest in DMD as well as other rare and orphan diseases that can have difficulties

Latest news

  • FDA reviewer unimpressed with PTC’s Translarna FDA reviewer unimpressed with PTC’s Translarna

    that the firm was emboldened by the FDA’s approval last year of another DMD therapy from Sarepta - Exondys 51 (eteplirsen) - after Janet Woodcock, head of the agency’s Center for

  • Sarepta eyes FDA filing for DMD drug golodirsen after positive trial Sarepta eyes FDA filing for DMD drug golodirsen after positive trial

    The exon-skipping drug raised functional dystrophin levels. Sarepta is preparing to file a follow-up to its Duchenne muscular dystrophy (DMD) treatment Exondys 51 that seems to have greater efficacy. ... Sarepta says its goal is to be able to prove a

  • FDA approves first steroid for Duchenne muscular dystrophy FDA approves first steroid for Duchenne muscular dystrophy

    The agency granted orphan and priority review status for the drug, which is the second DMD treatment to be approved in the US after Sarepta Therapeutics' exon-skipping therapy Exondys 51

  • A rock and a hard place A rock and a hard place

    Last month the FDA approved Sarepta's Duchenne muscular dystrophy (DMD) drug known as Exondys 51. ... The noteworthy aspect of this approval was that the FDA committee was decidedly split on whether the data presented as part of Sarepta's submission

  • Sarepta soars as FDA clears its muscular dystrophy drug Sarepta soars as FDA clears its muscular dystrophy drug

    Sarepta soars as FDA clears its muscular dystrophy drug. Analysts anticipate blockbuster status for DMD therapy despite efficacy concerns. ... Sarepta shares closed up 74% yesterday after news of the conditional approval for Exondys 51 (eteplirsen) broke

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Latest Intelligence

  • Deal Watch February 2017 Deal Watch February 2017

    Licence. 145. Sarepta Therapeutics/ Gilead Sciences. PRV received when EXONDYS 51 was FDA approved for Duchenne muscular dystrophy.

  • Deal Watch October 2016 Deal Watch October 2016

    The licence deal obtained by Summit from Sarepta for a phase II product had an even lower upfront, 7% of the total consideration. ... 767. Sarepta (US). Summit (UK). Licence collaboration. Europe Utrophin modulator pipeline, lead molecule phase II for

  • Pharma deals during November 2014 Pharma deals during November 2014

    BioMarin clearly feels that there is still a real opportunity and is prepared to take on Sarepta and PTC Therapeutics in the competition to hustle ahead new DMD drugs to regulators.

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