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

Europe’s Two-headed Monster: Divergent Demands For Comparators Squeeze Rx Trials

This article was originally published in The Pink Sheet Daily

Executive Summary

Medicines agencies and HTA bodies often ask for different clinical trials, and industry has become concerned that additional studies will cost too much and delay market access.

You may also be interested in...



Rasi At The EMA: Redefining Benefit/Risk As Staggered Approvals Rise

The Executive Director of the European Medicines Agency Guido Rasi’s dual goals of increasing safety and overall accountability undoubtedly will benefit patients and industry alike, but a grueling task lies ahead.

Benlysta And Fampyra Fail to Make Headway As IQWiG Tightens Comparator Screw

Germany’s health technology evaluator’s rejection of GSK’s Benlysta and Biogen Idec’s Fampyra could force companies to design separate trials for authorization and HTA assessment.

Germany’s IQWiG Downs Two Drugs In One Day

IQWiG turned down both GSK/Valeant’s Trobalt and Novartis’ Rasilamlo for lack of evidence of added benefit, after manufacturers’ choice of comparator deviated from those selected by the G-BA.

Related Content

Topics

Related Companies

Latest Headlines
See All
UsernamePublicRestriction

Register

PS073966

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