Pink Sheet is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

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

Sarepta's Eteplirsen Is Centerpiece Of Senate Hearing On Expanded Access

This article was originally published in The Pink Sheet Daily

Executive Summary

Witnesses call for political pressure on FDA to approve the Duchenne drug; patients and advocates also urge general approval reciprocity with Europe and incentives for pediatric trials; agency was not invited to testify.

You may also be interested in...



Political Appointees Shouldn't Influence Approval Decisions, Califf Says

FDA commissioner offers new details about why he left final decision on Sarepta's controversial Duchenne muscular dystrophy drug to FDA's expert bureaucrats.

FDA Can't Win On Guidances: Expanded Access Policy, Duchenne Worries Collide

Keeping guidances in draft form makes Congress angry, but finalizing them gives Wall Street the vapors.

Sarepta's Eteplirsen Review Delay Emboldens Duchenne Community

Is the lack of rejection cause for optimism, or will eteplirsen end up like BioMarin's drisapersen?

Related Content

Topics

Related Companies

Latest Headlines
See All
UsernamePublicRestriction

Register

PS079150

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

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