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

LIGHT Data Release Raises Heavy Issues for Small Sponsors

This article was originally published in RPM Report

Executive Summary

It was supposed to be good news: Orexigen announced a new patent for its weight loss drug Contrave, supported by strong CV safety data from the interim analysis of LIGHT. The controversy that followed underscores how hard it will be for small sponsors to satisfy FDA in the future when it comes to protecting interim data from long term outcomes trials.

Topics

Related Companies

Latest Headlines
See All
UsernamePublicRestriction

Register

PS079830

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