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

FDA's Withdrawn Reg On Data Fraud Hangs Over Zolgensma Incident

Executive Summary

Democratic senators push data-challenged gene therapy into maw of drug pricing debate as they press acting commissioner Sharpless to bring the hammer down on Novartis, but also question US FDA's decision to withdraw the proposed rule last year.

You may also be interested in...



Data Manipulation Not Common, But Happens "More Than I Would Have Expected," US FDA's Sharpless Says

As fallout from the Novartis Zolgensma data manipulation incident continues, US FDA acting commissioner Norman Sharpless notes that "at some level we have to trust the sponsors."

Zolgensma Fall-Out: Is Threat To Novartis – Or US FDA Climate Overall?

FDA’s disclosure of data “manipulation” in the application for the SMA gene therapy Zolgensma prompted two immediate inquiries from the US Senate – with very different focuses and potential outcomes.

Novartis' Zolgensma Had Manipulated Data In Application, US FDA Says

Gene therapy should remain on the market, FDA says, but Novartis could face civil or criminal penalties. Firm knew of problems before approval.

Related Content

Topics

Related Companies

Latest Headlines
See All
UsernamePublicRestriction

Register

PS140656

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