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

Priority Review Voucher Eligibility List Gains Three Tropical Diseases

Executive Summary

US FDA adds brucellosis, opisthorchiasis and paragonimiasis to the list of qualifying diseases but declines to include clonorchiasis and coccidioidomycosis, finding a significant market in developed nations for treatments or vaccines addressing the two conditions.

You may also be interested in...



Coccidioidomycosis Outlook Highlights The Limits Of Regulatory Incentives

The US FDA heard a lot about the structural, medical and especially financial barriers facing coccidioidomycosis, or Valley fever, drug development soon after the agency refused to qualify the rare fungal infection for priority review voucher incentives.

Sickle Cell Disease Should Qualify For Tropical Disease Priority Review Voucher, Group Says

In citizen petition to US FDA, rare diseases nonprofit group asks agency to add sickle cell disease to its tropical disease PRV list since the disease predominantly impacts those who live in Africa and the African American population in the US.

Neglected Tropical Disease Designation Rejected For First Time By US FDA

Pneumocystis pneumonia was determined to not meet criteria for a neglected tropical disease that could win sponsors of a new treatment a priority review voucher; FDA made four other diseases eligible. 

Topics

Latest News
See All
UsernamePublicRestriction

Register

PS142556

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