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

The End of Priority Review Vouchers? Reactions to Novarits' Ilaris Panel and Incentives for Tropical Disease Research

This article was originally published in RPM Report

Executive Summary

A supplemental BLA submitted by Novartis is the first product to use a priority review voucher to support the review. After a rejection by an advisory committee, will it also be the last? Advocates for tropical disease reseach weigh in with perspectives on the vocuher and other incentives.

You may also be interested in...



PCSK9 Meets PRV: Regeneron’s $70 Mil. Bid To Catch Up To Amgen

Regeneron and its partner Sanofi have become the first biopharma companies to buy a Priority Review Voucher. The $67 million price is a nice bonus for the seller, BioMarin, but probably not the start of a big new market for PRVs.

Another Chance to Make Priority Review Vouchers Work

One of the “innovation” pieces of the FDA Safety & Innovation Act is a priority review voucher program for drugs to treat pediatric rare diseases. The new PRV is designed to avoid some of the glitches that have complicated the value of the program in tropical diseases—but it can’t avoid the core problem inherent in trying to capture the value of a priority review by legislative fiat.

Novartis Coartem NDA May Lead to First Priority Review Voucher

Malaria drug receives "priority" status from FDA, which should mean Novartis receives a voucher for priority designation on another product under new incentive program for tropical disease research. December application deadline also sets a deadline for FDA to defi ne key elements of how PRVs will work.

Related Content

Topics

Latest News
See All
UsernamePublicRestriction

Register

PS080872

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