In any other circumstance, the US FDA's Peripheral & CNS Drugs Advisory Committee’s Sept. 28 meeting on PTC Therapeutics Inc.’s ataluren would have been one that most sponsors could afford to skip since the briefing documents made clear the agency didn't believe ataluren’s efficacy had been demonstrated in the two trials completed by PTC to date.
FDA’s DMD Decisions: Glass Two-Thirds Full?
The outcome of an US advisory committee review of PTC’s ataluren was not surprising. That is bad news for PTC’s prospects of launching the drug in the near term – but given the recent history of the DMD class, it is probably good news for biopharma companies overall as a sign that FDA's neurology group is moving forward effectively.
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Stay up to date on regulatory guidelines from around the world with the Pink Sheet's Guidance Tracker. The complete Global Pharma Guidance Tracker, with sortable and searchable listings going back to 2014, is available online.
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This is an update of recommendations from the European Medicines Agency's Committee for Medicinal Products for Human Use on the authorization of new medicines in the EU, and updates on EU marketing authorization changes recommended by the CHMP.
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