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

AMAG’s Turnaround Plans Hit A Snag With Feraheme CRL

This article was originally published in The Pink Sheet Daily

Executive Summary

FDA declined to approve the I.V. iron in a broad patient population and requested another clinical trial to further evaluate safety. The decision gives rival Daiichi more time to penetrate the market with its I.V. iron Injectafer.

You may also be interested in...



FDA Trial Design Challenge: Does Same Indication Demand Same Kind Of Study?

Luitpold citizen petition seeking to block AMAG’s expanded indication for injectable iron offers FDA an opportunity to weigh in on how similar trial designs must be for drugs with the same indication.

A New Course For AMAG: Expanding Feraheme And Moving Beyond Iron

AMAG is looking to build out its portfolio by in-licensing or acquiring new commercial products that complement its I.V. iron product Feraheme. The company is in negotiations for multiple assets, while at the same time preparing to launch Feraheme into a broader patient population.

IPO Update: Patheon Public Once Again, Audentes To Move Into The Clinic

Two companies in the biopharma space began trading publicly this week, one to pay off debt, the other to fund an early-stage pipeline.

Topics

Related Companies

Related Deals

Latest News
UsernamePublicRestriction

Register

PS076410

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