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

Orphan Drugs Should Be Rarer, Insurers Urge, Citing Price Increases

Executive Summary

FDA can improve drug pricing by limiting the number of orphan designations, AHIP argues; worryingly for industry, the agency appears to be already thinking along similar lines.

You may also be interested in...



Keytruda's New Tissue-Agnostic Indication Could Prompt Orphan Policy Changes

US FDA contemplating how to match orphan designation process with drug development moving to molecularly-targeted therapies.

Disease 'Subsetting' Not Driving Jump In Orphan Designations, US FDA Says

Preliminary study results suggest policy tweaks may not be necessary, even as an oncology orphan product rush appears to be coming.

Targeted Therapies On FDA’s Orphan Designation Radar

As personalized medicine continues to grow, FDA is watching to see if there is a rise in orphan designations for products targeting a “smaller slice” of a common disease.

Topics

Related Companies

Latest Headlines
See All
UsernamePublicRestriction

Register

PS118978

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