Pink Sheet is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction
UsernamePublicRestriction

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.

Related Content

Topics

Related Companies

UsernamePublicRestriction

Register

LL1134409

Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel