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.
Need a specific report? 1000+ reports available
Buy Reports
Register for our free email digests: