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
UsernamePublicRestriction

New Therapeutic Targets & A Rich Year For Approvals: EMA’s PRIME In 2020

Executive Summary

Last year saw the number of applications accepted onto the European Medicines Agency’s priority medicines scheme inch up and the notoriously high rejection rate for applications drop.

You may also be interested in...



Product Accepted Twice On PRIME Marks A First For EMA

Vertex and CRISPR can now get access to the advantages afforded by the European Medicines Agency’s priority medicines scheme for both of the indications they are targeting with their investigational gene therapy, CTX001.

Pre-Launch Demand Outstrips Supply For Zydus COVID-19 Vaccine

Zydus Cadila expects to launch its DNA COVID-19 vaccine in the first quarter of fiscal 2022 but it already has more advance purchase orders than it can produce. Meanwhile, the Indian firm is confident of saroglitazar being approved for primary biliary cholangitis in the US, with the NCE also poised to become the largest contributor to India sales in three to five years.

EMA Tells Companies How To Boost Their Approval Chances Under PRIME

Companies find it challenging when it comes to preparing robust quality data packages for their marketing applications for investigational products that have made it onto the European Medicines Agency’s popular priority medicines scheme.

Related Content

Topics

Related Companies

UsernamePublicRestriction

Register

PS143684

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