PTC To Appeal Translarna's Complete Response Letter From US FDA
Executive Summary
PTC Therapeutics appears to be hoping that CDER Director Woodcock will do for ataluren what she did for Sarepta's exon-skipping Duchenne muscular dystrophy treatment Exondys 51 since dispute resolution request would first go to Office of New Drugs, where Woodcock is acting director.
You may also be interested in...
Keeping Track: US FDA Greenlights Two More Novel Drugs, But Smacks Down Golodirsen
The latest drug development news and highlights from our US FDA Performance Tracker.
Orphan Drug Makers Would Escape Price Reporting Requirements Under House Bill
Legislation pending in US House Energy and Commerce Committee would exempt drugs treating diseases with less than 200,000 patients from needing to justify price increases.
PTC To Fight EMA Translarna No, Novartis Considers Revolade Next Steps
PTC Therapeutics and Novartis are working on their next steps after the European Medicines Agency recommended against approving their requests to expand the indication of their respective products in the EU.