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

Type 2 Diabetes Developers Take Heart: New Safety Hurdle Is Surmountable

Executive Summary

The April 1-2 meeting of the Endocrinologic & Metabolic Drugs Advisory Committee ended in equivocal results for the sponsors involved, but sends an unequivocal message of hope to diabetes drug development companies: the new cardiovascular safety bar adopted by FDA in December is surmountable

You may also be interested in...



FDA Will Soon Finalize Obesity Guidance, May Tackle CV Safety Separately

The fuzzy regulatory picture for the challenging obesity space is about to come into focus with two actions from FDA: the agency is expected to issue final guidance on weight management drug development soon and, later, may consider requirements for proof of cardiovascular safety, in the vein of the recent guidance on diabetes drugs

FDA Will Soon Finalize Obesity Guidance, May Tackle CV Safety Separately

The fuzzy regulatory picture for the challenging obesity space is about to come into focus with two actions from FDA: the agency is expected to issue final guidance on weight management drug development soon and, later, may consider requirements for proof of cardiovascular safety, in the vein of the recent guidance on diabetes drugs

FDA Will Soon Finalize Obesity Guidance, May Tackle CV Safety Separately

In wake of rimonabant, formal evaluation of depression will probably be needed for centrally acting drugs.

Related Content

Topics

UsernamePublicRestriction

Register

PS050925

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