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

FDA Cuts Priority Review Voucher Fee By 32%; J&J In Line For Next Voucher?

This article was originally published in RPM Report

Executive Summary

By taking into account the incremental costs of priority review and eliminating the IND aspect of the calculation, the agency reduces the fee to redeem a tropical disease priority review voucher to $3.6 million in fiscal year 2013. That may benefit J&J, assuming a pending tuberculosis agent is approved by FDA.

You may also be interested in...



J&J’s Bedaquiline: 10 Days Early For GAIN Incentive

Janssen Pharmaceuticals’ MDR-TB compound bedaquiline has the right indication to get an extra five years of exclusivity through the Generating Antibiotic Incentives Now Act – but the NDA was submitted too early to qualify.

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.

R&D For Diseases Of Developing Countries Could Be Driven By Pooled Funds

WHO committee backs use of pooled funds to finance R&D, nixes priority review vouchers and finds no need for data exclusivity. Novartis’ Paul Herrling, a committee member, notes that governments would be responsible for R&D costs.

Related Content

Topics

Related Companies

Latest Headlines
See All
UsernamePublicRestriction

Register

PS081037

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