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

EPO Market Stabilizes, But For How Long?

This article was originally published in RPM Report

Executive Summary

Amgen hoped it would be turning the page on the regulatory and reimbursement problems that dogged Aranesp and made 2007 a year to forget. But more negative data means another trip to an FDA advisory committee, and this time Wall Street is bracing for the worst.

You may also be interested in...



The ESA Disconnect Between FDA and CMS

Another major decision is looming at CMS on whether to open up a national coverage analysis for ESAs in the renal disease area-a MEDCAC meeting appears to be the first step. The Medicare agency previously jumped out in front of FDA on a coverage decision in the oncology setting. This time, it appears that CMS will wait to hear what FDA has to say. But FDA isn't paying much attention to CMS.

The Slow Death of a Blockbuster

Bad news continues to mount for erythropoiesis-stimulating agents (ESAs), the flagship products of the biotechnology industry. Far from developing new markets, postmarket clinical trials by Amgen and J&J continue to point towards a much smaller appropriate patient population for Aranesp and Procrit.

Aranesp Declines Put More Pressure On Amgen For Denosumab Success

With sales of Amgen's blockbuster anemia franchise in a freefall and competitive threats to its tumor necrosis factor inhibitor Enbrel looming, the big biotech is banking on the osteoporosis treatment denosumab to drive growth in the years ahead

Related Content

Topics

Related Companies

UsernamePublicRestriction

Register

PS080392

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