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

Decision Time For MSD/AZ, Lilly, Kite EU Fast-Track Hopes

Executive Summary

Three accelerated assessment requests will either be granted or rejected this week at the European Medicines Agency.

You may also be interested in...



AstraZeneca/MSD’s Koselugo Among 14 New Hopefuls At EMA

New drugs from Eli Lilly, Pfizer, Janssen, GSK, Arvelle, BioCryst, Diurnal and Myovant are also among the latest products the European Medicines Agency is evaluating for potential pan-EU approval.

EU Speedy Review Success For Kite But Not For Lilly

KTE-X19, Kite’s potential new CAR-T therapy, will in the end be fast-tracked at the European Medicines Agency. Lilly failed to secure the speedy review it was seeking for selpercatinib

Fast-Track Fail For Kite’s KTE-X19 EU Review?

Priority review is likely in the US for Kite’s second CAR-T therapy offering but it seems the company will have to make do with standard review in the EU. 

Related Content

Topics

Related Companies

UsernamePublicRestriction

Register

PS141332

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