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 Accelerated Assessment – Hard To Get, Hard To Keep

Executive Summary

It’s hard enough in the first place for companies to persuade the European Medicines Agency that their planned marketing authorization application should be fast-tracked. Many are also finding that after accelerated assessment is granted, it is taken away during the actual review.

You may also be interested in...



Accelerated Assessment Dry Spell Over As EMA Says Yes To Pharming’s Leniolisib

Leniolisib has become the first product to be granted accelerated assessment status by the European Medicines Agency this year.

Critical Juncture In Zolgensma EU Market Quest

If Zolgensma gets the thumbs up from the EMA this week, it will likely get formal EU approval within a couple of months. 

EMA Crunch Time For Shionogi’s Novel Antibiotic Cefiderocol

The EU marketing application for cefiderocol that lost fast track status last July is now up for an opinion by the European Medicines Agency.

Related Content

Topics

Related Companies

Latest News
See All
UsernamePublicRestriction

Register

PS140535

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