Pink Sheet is part of the Informa Intelligence Division 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


Half Of All EU Fast-Track Requests Fail; AZ’s Imfinzi Among Latest

Executive Summary

The European Medicines Agency recently denied AstraZeneca’s pre-filing request for accelerated assessment of Imfinzi in Stage III NSCLC, an indication the company is hoping to make its own. It’ll be no consolation that the EMA this year seems to have rejected as many fast-track requests as it has granted.


Related Content

New EMA Filings: Speedy Review For Lanadelumab But Cemiplimab Gets Standard Treatment
‘Outstanding Issues’ Near For Products Approaching EU Review End – Including Neulasta Biosimilar
Lilly, Novartis, Jazz and Ionis Take New Products To EMA
Ocrevus Tries Again For EU Approval Nod
No EU Fast Track for AZ’s Imfinzi In Stage III Lung Cancer
Sanofi Secures EMA Accelerated Assessment For Sleeping Sickness Drug
Jazz On Track With Q4 EU Filing for Leukemia Treatment Vyxeos
Keeping Track Of Novel Agents: US FDA Approves Nerlynx And Vosevi, Turns Down Evenity; Macrilen Returns
New Anti-CMV Therapies Post-Transplant: Merck & Co Leads The Pack


Related Companies




Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

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