Scrip 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

Novartis yanks imatinib PAH NDA; FDA wants more data, cancels AdCom

This article was originally published in Scrip

Executive Summary

The first sign there may be trouble with Novartis' new drug application (NDA) for imatinib as a pulmonary arterial hypertension (PAH) treatment came on 15 August when the US FDA called off the 14 September meeting of its Cardiovascular and Renal Drugs Advisory Committee, although regulators declined to disclose the trigger for the cancellation.

You may also be interested in...



Finance Watch: 2020 Cell And Gene Therapy Funding Already Bests 2019

Private Company Edition: The Alliance for Regenerative Medicine’s half-year report shows the sector raised $10.7bn in the first half of 2020 versus $9.8bn raised in all of 2019. Also, DCVC Bio closed a $350m fund, new incubator opportunities and VC mega-deals for Dyne and Atomwise.

Moderna's Valera Takes mRNA Approach To Combat Zika

With new funding in hand, Moderna and its infectious disease venture Valera are going full-speed ahead with a Zika vaccine, taking an mRNA approach, which they said could be a more rapid strategy to try to stop the disease.

Allergan's Price Reform Pledge: Will Others Follow?

Allergan CEO Brent Saunders vows not to engage in price gouging and says his firm will limit cost increases to single-digit percentages, occurring only once per year. But it's unclear whether Saunders will stand as a lone wolf in the industry or if others will make similar pledges.

Topics

Related Companies

UsernamePublicRestriction

Register

ID1132327

Ask The Analyst

Please Note: Click here for more information on the Ask the Analyst service.

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