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

FDA Advisory Committee Will Review ESAs In The Renal Setting Oct. 18

This article was originally published in The Pink Sheet Daily

Executive Summary

Meeting also could be next step in the process of determining whether safety issues are enough to drive changes to erythropoiesis-stimulating agent reimbursement at CMS.

You may also be interested in...



Can Amgen Stop The Bleeding As FDA Presses For A Low-Dose Aranesp Trial?

CardioRenal Advisory Committee will discuss whether there should be a trial testing lower dosing limits in CKD patients. With sales declines a forgone conclusion regardless, Amgen hopes to avoid the expense of a complex study.

Can Amgen Stop The Bleeding As FDA Presses For A Low-Dose Aranesp Trial?

CardioRenal Advisory Committee will discuss whether there should be a trial testing lower dosing limits in CKD patients. With sales declines a forgone conclusion regardless, Amgen hopes to avoid the expense of a complex study.

San Francisco-based FibroGen Gets SFDA Nod Through Green Channel Procedure

HONG KONG - San Francisco-based FibroGen announced that Chinese regulators approved the start of clinical trials of novel therapy FG-4592 for anemia associated with chronic kidney disease. The approval was expedited through China's two-year-old special approval procedure, or "green channel.

Related Content

Topics

Latest Headlines
See All
UsernamePublicRestriction

Register

PS071200

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