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...

Legal Notebook: Catalyst’s Suit vs. FDA Is Tossed, Avonex Patent Invalidity Verdict Is Reinstated

Court finds US FDA did not impede Catalyst orphan exclusivity for Firdapse as it approved different indication for competing product. Biogen loses 10-year patent battle against competing multiple sclerosis drug makers.

Naturopath Marketing Brain Defense Supplement Anticipates Support For Making TBI Claims

Cover Three Nutritional Brain Defense marketer agrees to pull claims suggesting the supplement beverage can protect against traumatic brain injury after a test the firm on DHA submitted as support contained considerably higher levels of the ingredient than included in the product.

Topics

UsernamePublicRestriction

Register

ID1132090

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