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

Lupus Clinical Trials Can Use Organ-Specific Endpoint For Broad Claim – FDA

Executive Summary

FDA's draft guidance on lupus drug development allows for the use of clinical trials on specific organs to support a broader lupus claim

You may also be interested in...



Siren Song Of Lupus Has Left A Legacy Of Failed Trials

The five-decade drought in FDA approvals of lupus therapies – broken by Human Genome Sciences Inc.'s recent launch of Benlysta – featured a steady stream of drug developers that were not dissuaded by the legacy of trial failures and shifting regulatory standards that marked the field, only to join the ranks of clinical failures in lupus.

Siren Song Of Lupus Has Left A Legacy Of Failed Trials

The five-decade drought in FDA approvals of lupus therapies – broken by Human Genome Sciences Inc.'s recent launch of Benlysta – featured a steady stream of drug developers that were not dissuaded by the legacy of trial failures and shifting regulatory standards that marked the field, only to join the ranks of clinical failures in lupus.

Emerging Phase III Data Validate Clinical Trial Design In Lupus

Over a span of little more than a month this summer, the face of clinical trials for lupus drugs changed considerably for the better.

Related Content

Topics

Latest Headlines
See All
UsernamePublicRestriction

Register

PS045605

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