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

New EU Speedy Review Hopefuls: Novimmune, AveXis, bluebird bio, and Loxo Oncology

Executive Summary

It is not easy for companies to convince the European Medicines Agency that their marketing applications merit accelerated assessment. Four new hopefuls are about to find out whether they have been successful.

You may also be interested in...



EU Accelerated Assessment Tracker: EMA To Fast Track Thalassemia Gene Therapy, New HIV Drug

Bluebird Bio’s LentiGlobin and Theratechnologies’ Trogarzo are both first of their kind treatments for transfusion-dependent β-thalassemia and HIV respectively.

Finance Watch: Summer Heat Extends To Biopharma IPOs With Nine In July, 45 This Year

Public Company Edition: Nine more biopharma companies launched IPOs in the US in July, bringing the 2018 total to 45 first-time offerings – three more than in all of 2017. Bluebird's $632.5m offering leads recent follow-on public offerings.

EU Accelerated Assessment Tracker: Rejection Is Standard Outcome For Fast-Track Requests This Year

Attempts by companies to have their investigational products fast-tracked through the EU approval system this year so far have largely failed. Often the same products have or had priority review in the US. With the European Medicines Agency deciding on four new accelerated assessment requests this week, will the tide start to turn?

Related Content

Topics

Related Companies

Latest Headlines
See All
UsernamePublicRestriction

Register

PS123552

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