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

US FDA’s Project Orbis Could Streamline Global Clinical Trials In Cancer

Executive Summary

Richard Pazdur tells the Pink Sheet that program for concurrent submission of oncology applications and collaborative review by global regulators also could speed approval in smaller countries; first applications under Project Orbis were for use of Lenvima/Keytruda combination for endometrial cancer in US, Canada, and Australia.

You may also be interested in...



Keeping Track: Good News For Deciphera, BMS And Clovis; Bad News For bluebird/BMS, Blueprint And Tonix

The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker.

Keeping Track: US FDA Clears Oncologics Tukysa And Jelmyto; Regeneron Anti-Ebola Cocktail Under Review

The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker.

China Unlikely To Be Included In US FDA's Project Orbis In The Near Term

Oncology Center of Excellence Director Pazdur says there must be confidence that confidentiality agreements are universally accepted in response to request that China be included in the multi-regulator application assessment program.

Related Content

Topics

Related Companies

UsernamePublicRestriction

Register

PS140851

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