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

Guerbet Looks To Separate Dotarem In Crowded Contrast Agent Market

This article was originally published in The Pink Sheet Daily

Executive Summary

FDA advisory committee scheduled for Valentine’s Day is key test for Guerbet’s efforts to get its MRI imaging agent a wider indication than Bayer’s Gadavist.

You may also be interested in...



FDA Panel Rejects Guerbet’s Imaging Drug Dotarem For Young Children

The gadolinium-based contrast agent should be approved for use in adults and older pediatric patients, but more data are needed to support a novel indication for children under two years old, the Medical Imaging Drugs Advisory Committee says.

Pediatric Claim For Guerbet’s Imaging Agent Dotarem Questioned By FDA

In advisory committee briefing documents, agency reviewers cite limitations in gadoterate’s pediatric experience, particularly among patients two years of age and younger. This is the key population that would differentiate Dotarem from other gadolinium-based contrast agents already on the market.

An NME Surge After The Patent Cliff? Reinvention Of R&D Starts Paying Off In 2013 New Product Candidates

With almost 40 novel agents already pending at FDA, 2013 looks like a good bet to repeat the strong NME and novel biologic approval counts of 2012 and 2011. Big pharma and big markets dominate the 2013 slate so far, especially with diabetes, respiratory and central nervous system candidates.

Related Content

Topics

Related Companies

UsernamePublicRestriction

Register

PS074835

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