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


When To End A REMS? Soliris Review Stirs Debate On How To Scale Back

Executive Summary

Risk management program for Alexion’s orphan drug eculizumab appears to be succeeding, but what does FDA need to see to make it less burdensome?

You may also be interested in...

If It Ain’t Broke…: FDA Committee Supports Retaining Soliris REMS

FDA’s annual REMS reviews haven’t been the most dramatic advisory committees in recent years. The latest review is the first to involve a major commercial product – Alexion’s Soliris – but also looked at a program that appears successful and non-controversial.

NICE's Nod To Soliris Tainted By Request For R&D Cost Data

The U.K.s NICE is on the verge of recommending Alexion's Soliris for aHUS despite an astronomic price; but its request for R&D cost data will alarm the drug industry.

FDA Panelist Questions Marketing Benefits From Soliris REMS

Cleveland Clinic hematologist suggests eculizumab risk management plan provides Alexion with an opportunity for direct-to-consumer marketing.

Related Content


Related Companies

Latest Headlines
See All



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