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

Advanced Magnetics ferumoxytol update

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Advanced Magnetics plans to submit an NDA for its iron replacement therapy ferumoxytol for use in anemic chronic kidney disease patients, regardless of dialysis status, "during the first half of 2006," the firm says Jan. 13. Submission was previously projected by the end of 2005 (1Pharmaceutical Approvals Monthly May 1, 2004, In Brief). The company also announced initiation of a large-scale, multi-center Phase III safety study, which will be the last study in the iron therapy program. Ferumoxytol is also in "exploratory Phase II clinical studies for use as a contrast agent in magnetic resonance angiography"...

You may also be interested in...



Advanced Magnetics ferumoxytol enters Phase III

Advanced Magnetics anticipates submitting an NDA for its iron replacement therapy ferumoxytol for use in anemic chronic kidney disease (CKD), regardless of dialysis status, by the end of 2005. The firm has initiated two identical Phase III trials in anemic CKD patients not yet on dialysis; a Phase III study in anemic CKD patients on dialysis is slated to begin in the second-quarter. Advanced Magnetics anticipates the initiation of Phase III trials for use in magnetic resonance angiography before the end of 2004...

Keeping Track: Quick Trips From Breakthrough Designation To Market

Phase III data earns a breakthrough therapy designation for Resverlogix’ apabetalone; previous companies to follow that strategy swiftly advance to NDA submission, as seen with Novartis’ capmatinib and Seattle Genetics’ tucatinib.

Breakthrough Therapy Designations: Phase II Data Is Sweet Spot For US FDA Award

Pink Sheet analysis finds that evidence from early-stage trials supports most BTD requests, but about three in 10 designations are granted on the basis of pivotal-stage data.

Topics

UsernamePublicRestriction

Register

PS002748

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