EU regulators to review Evrysdi for SMA
The decision triggers a £15m milestone payment from Roche to PTC Therapeutics
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Tag: PTC
PTC submits MAA for new gene therapy
The company expects a CHMP decision in the second half of 2020.
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FDA rejects PTC’s DMD drug Translarna
PTC Therapeutics will need to carry out at least one further trial to demonstrate the effectiveness of its Duchenne Muscular Dystrophy therapy Translarna if it is to have a chance of bagging its approval in the US.
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FDA rejects PTC’s appeal over failed Translarna filing
PTC Therapeutics has been denied its first appeal contesting US regulators’ refusal to accept its marketing application for Translarna as a treatment of nonsense mutation Duchenne muscular dystrophy (nmDMD).
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Duchenne patients get NHS access to PTC’s Translarna
Cost regulators for the NHS in England and Wales have now issued final guidance recommending the use of PTC Therapeutics’ Translarna for patients with Duchenne muscular dystrophy.
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NHS England, PTC reach agreement on Duchenne drug
Children in England suffering from a rare form of muscular dystrophy will soon be able to access the only drug licensed for their condition after a ground-breaking agreement was reached between NHS England and PTC Therapeutics.
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