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

Takeda Heartburn Drug Encounters Delay At U.S. FDA

This article was originally published in PharmAsia News

Executive Summary

A heartburn drug of Takeda's U.S. arm has encountered a snag in its effort to gain approval by the U.S. FDA. The agency notified Takeda Pharmaceuticals of North America it would not be able to complete a review as expected by the end of October. At issue is the TAK-390MR proton pump inhibitor intended for treating gastroesophageal reflux disease and other serious acid-related problems. The agency told Takeda it would need another three months to review all the data supplied by Takeda. A spokesman said Takeda's drug has elements that differ from existing proton pump inhibitors. (Click here for more

You may also be interested in...



Genmab Accelerates Priority Candidates, Ends Enapotamab Vedotin Development

Denmark’s biotech Genmab has dropped the AXL targeted antibody-drug conjugate, enapotamab vedotin from early clinical development, and is focusing its resources on other therapeutic programs.

Novartis CEO Touts R&D 'Wild Cards' As Proof Of Deep Pipeline

Potentially transformative treatments for severe asthma, COPD and osteoarthritis are among some of the below-the-radar projects the Swiss major is advancing, according to Vas Narasimhan. 

Deal Watch: Lilly Finds New Partners For Genetic Disorders, Protein Degradation

Pharma’s latest partnerships focus on Duchenne muscular dystrophy with Precision Biosciences, protein degradation with Seed. Bristol and Schrodinger team in computational drug discovery.

UsernamePublicRestriction

Register

LL1134531

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