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

EU Industry Wants ‘More Fluid’ Accelerated Assessment Procedure At EMA

Executive Summary

EFPIA says that the European Medicines Agency’s fast-track regulatory review mechanism can be perceived by sponsors as being “hard to get and easy to lose.”

You may also be interested in...



FDA’s Califf Speaks Of Tailoring Trials For CMS Evidence Amid Spotlight On Alzheimer’s Drugs

FDA Commissioner Robert Califf spoke of the need for a better hand-off to CMS, including tailoring trials to generate evidence relevant for Medicare coverage. He also weighed in on the possibility of accelerated approval for chronic disease drugs, among other topics.

EMA Bolsters PRIME Scheme With Improvements

The European Medicines Agency will hold submission readiness meetings with the sponsors of products in the priority medicines scheme around a year ahead of them submitting their marketing authorization applications for regulatory review.

New EU Filings

Acoramidis, AstraZeneca/BridgeBio Pharma's investigational treatment for patients with transthyretin amyloid cardiomyopathy, is among the latest products that have been filed for review by the European Medicines Agency for potential EU marketing approval.

Topics

Latest Headlines
See All
UsernamePublicRestriction

Register

PS148232

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