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

Reimbursement Challenge: CMS Questions Azedra Endpoint While Still Under FDA Review

Executive Summary

Progenics' radiopharmaceutical using novel surrogate endpoint for US FDA review; CMS seems unimpressed, which doesn't bode well for new technology add-on payment.

You may also be interested in...



Keeping Track: Ilumya, Adcetris Approved; Xtandi Priority Reviewed; Azedra Goal Date Extended

The latest drug development news and highlights from our US FDA Performance Tracker.

US FDA Pushes Back On Proposal For Early Clinical Designations To Support Higher Reimbursement Decisions

Breakthrough, RMAT designations signal clinical potential and are not intended to have reimbursement impact after approval, FDA says. 

Rx Vial Size: FDA Stresses Safety Issues Amid Push To Find Savings For Payors

There may be significant savings from eliminating wasteful packaging for high cost specialty drugs. The US FDA, however, is urging policy makers not to overlook the importance of patient safety in packaging issues.

Topics

Related Companies

UsernamePublicRestriction

Register

MT142539

Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

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