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


Gadavist Dosing Complexities To Be Handled With Packaging, Not REMS

This article was originally published in The Pink Sheet Daily

Executive Summary

Bayer's newly approved gadolinium-based contrast agent only needs half the dose of other such products. The label eschews comparative safety claims.

You may also be interested in...

R&D In Brief: Imaging Agent Approvals, EULAR Updates, Post-ASCO Cancer Data

FDA approves new oncology imaging agents and a long-acting hemophilia drug; Sanofi/Regeneron present positive Phase III on RA drug sarilumab; biosimilar infliximab shows no meaningful differences to Remicade; Imbruvica response rates improved with umblituximab; Cyramza fails survival endpoint in liver cancer.

Guerbet Looks To Separate Dotarem In Crowded Contrast Agent Market

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.

FDA Forgoes Sponsor Support In Safety Study Of Contrast Agents To Avoid Potential Bias

Instead of requiring sponsors to conduct a study, the agency is providing grant to the University of Pittsburgh Medical Center to create a prospective registry that will examine the relationship between exposure to gadolinium-based contrast agents and nephrogenic systemic fibrosis.

Related Content





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