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

BIO Priorities: Negotiating Medicare Reimbursement, Reducing Drug Development Times

This article was originally published in The Pink Sheet Daily

Executive Summary

"Eternal vigilance" is necessary to ensure reimbursement is not adversely affected by implementation of Medicare drug benefit law, BIO Chairman Pops says. Group will work to ensure that FDA initiatives reducing drug development times continue after McClellan departs.

You may also be interested in...



McClellan To Head Medicare Rx Law Implementation: Will Greater FDA/CMS Cooperation Ensue?

President Bush nominates FDA Commissioner McClellan to head Centers for Medicare & Medicaid Services Feb. 20. McClellan's closest advisors will remain at FDA, suggesting era of greater cooperation between the two agencies could result.

Able Unable To Reform On Its Own? Firm Seeks Consent Decree To Address Manufacturing Issues

“We are prepared to enter discussions toward a decree at FDA’s earliest convenience,” Able says in letter to FDA. Company is pursuing consent decree instead of responding to FDA Form 483 report citing manufacturing deficiencies. The letter follows CEO Maury’s resignation the previous day.

Astellas Ends Aczone Acne Treatment Collaboration Agreement With QLT

QLT now has worldwide marketing rights to the topical acne treatment. Astellas believes labeling proposed by FDA will limit the market profile for Aczone, the company said. Aczone’s user fee deadline is July 7.

Topics

Latest Headlines
See All
UsernamePublicRestriction

Register

PS058706

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