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...
MoCRA’s Adulteration Ambiguity And FDA’s New Cosmetic Recall Authority: Attorney Weighs In
The US FDA should use guidance or rulemaking to clarify MoCRA provisions related to adulteration, Amin Wasserman Gurnani attorney Angela Diesch suggested at the Independent Beauty Association’s Cosmetics Convergence Spring Symposium. Attendees also sought her take on whether the agency’s new recall authority is likely to spell an increase in cosmetic product recalls.
Medtronic Launches Remote Live-Stream Surgery, New AI Capabilities
Medtronic will launch a new feature that allows for live streaming of surgical procedures in more than 20 countries and the addition of 14 AI-driven algorithms to enhance surgical workflow.