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

FDA Conflict Of Interest Waiver On Victoza Is Textbook Example For Supporters, Foes

Executive Summary

Novo Nordisk's Victoza will get US advisory committee review June 20, and Tufts Medical Center's Marvin Konstam will serve on panel even though his institution participates in a trial for Janssen's Invokana.

You may also be interested in...



Victoza’s Non-Cardio Safety May Dominate At FDA Panel Review

US FDA does not raise any major concerns about study’s design or results to support cardiovascular risk reduction claim for Novo Nordisk’s GLP-1 agonist liraglutide ahead of advisory committee, but agency gives close scrutiny to non-CV safety events of interest.

Can A Safety Study Support A Superiority Claim? Barely, FDA Advisors Say

FDA advisory committee narrowly endorses CV mortality benefit claim for Boehringer/Lilly's diabetes drug Jardiance, but some panelists question wisdom of relying on study originally designed for cardiovascular safety to support a post-marketing superiority claim.

The FDA Amendments Act-A Year On

The US Food and Drug Administration Amendments Act of 2007 came into force just over a year ago and contained important ramifications for manufacturers of medical devices and in vitro diagnostics. Neena Brizmohun reports from the annual meeting of the Regulatory Affairs Professionals Society, in Boston, on how the act is faring.

Topics

Related Companies

UsernamePublicRestriction

Register

PS120810

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