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

Sarepta's Eteplirsen Approved After Contentious Internal FDA Debate

Executive Summary

CDER Director Woodcock grants accelerated approval after FDA Commissioner Califf refuses to overturn her finding that the drug's effect on dystrophin is reasonably likely to predict clinical benefit in Duchenne muscular dystrophy.

You may also be interested in...



Stockwatch: Lax Approval Requirements Yield Blockbusters That Don’t Work

With the backdrop of Biogen’s BLA filing, and the FDA’s expected response for aducanumab in Alzheimer’s disease in 2020, the link between efficacy and approval seems to have broken. Conditional FDA approvals can’t help when the conditions are ignored.

Court Rules More Trial Data Must Be Posted On ClinicalTrials.gov

Plaintiff Peter Lurie, former US FDA associate commissioner, expects results of hundreds of clinical trials of approved medical products will become available under ruling against HHS.

Court Rules More Trial Data Must Be Posted On ClinicalTrials.gov

Plaintiff Peter Lurie, former US FDA associate commissioner, expects results of hundreds of clinical trials of approved drugs will become available under ruling against HHS; co-plaintiff sought eteplirsen study data.

Related Content

Topics

Related Companies

UsernamePublicRestriction

Register

PS119160

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