Pink Sheet is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

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

Comparing EU Vs. US Accelerated Pathway Approval Times Makes Senior UK Regulator 'Slightly Defensive'

This article was originally published in The Pink Sheet Daily

Executive Summary

Record-setting US Blincyto approval is case in point for discussion; EMA/MHRA official Robert Hemmings says EU review structure taps into expertise from "the whole of the continent," plus rapporteurs' independent views.

You may also be interested in...



European Notebook: Bayer Bids For Monsanto; Biosimilar Uptake Still Sluggish; EMA Enters Drug Pricing Debate

The restructuring of business portfolios occupies Europe's big pharma companies, while the region's health providers look to improve the uptake of biosimilars, and European regulators suggest ways to use greater market competition to tame high drug prices. Plus Brexit, trade agreements, pharmacovigilance and more in this month's column.

"Lagging Indicators": Is There A "Drug Lag" Between U.S. And Europe?

FDA's John Jenkins discusses concerns about return of the "drug lag" during IoM meeting on drug safety.

EU Accelerated Assessment Tracker

Marinus’s ganaxolone has lost its accelerated assessment status mid-review at the European Medicines Agency while Roche’s glofitamab will be fast-tracked once a filing has been made.

Topics

UsernamePublicRestriction

Register

PS079422

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