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Exondys

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

CHMP backs Spark’s Luxturna, but rejects Sarepta again

CHMP backs Spark’s Luxturna, but rejects Sarepta again

therapies. The CHMP turned down Sarepta’s application for Exondys in May, but was asked to re-examine the evidence by the company. ... which there was no meaningful difference between Exondys and placebo in the 6-minute walking distance.”.

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  • Europe vs the US: New drug product approvals Europe vs the US: New drug product approvals

    Among the noteworthy orphan approvals are Exondys 51 (for the treatment of Duchenne muscular dystrophy, only approved in the US), Darzalex (for the treatment of multiple myeloma, approved in the US

  • 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.

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