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

Esbriet, Ofev Reviews Convinced FDA Of Acceptable IPF Endpoint

Executive Summary

FDA leaders explain in NEJM how they came to accept a measure of lung function as a surrogate for mortality in trials of idiopathic pulmonary fibrosis therapies. See how agency reviewers handled this in a preview of our upcoming Drug Review Profile series.

You may also be interested in...



Pliant Sees Treating Fibrosis As Primary Goal, Not Add-On

The start-up will advance UCSF research on fibrosis to improve upon current treatments for idiopathic pulmonary fibrosis, and possibly create therapeutics for fibrosis of the liver, kidneys and GI tract as well.

Pliant Sees Treating Fibrosis As Primary Goal, Not Add-On

Start-up will advance UCSF research on fibrosis to improve upon current treatments for idiopathic pulmonary fibrosis, and possibly create therapeutics for fibrosis of the liver, kidneys and GI tract as well.

When Should Unmet Need Trump Inadequate Data?

The Esbriet review exemplifies FDA’s eternal struggle between requiring adequate evidence of efficacy and giving patients with deadly diseases a chance at treatment.

Related Content

Topics

Related Companies

Latest News
See All
UsernamePublicRestriction

Register

PS056748

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