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

Dual Approval For Verzenio Under International Review Scheme

Executive Summary

The joint review by Australia and Canada of the metastatic breast cancer drug, Verzenio, helped regulators in both jurisdictions achieve efficiencies.

You may also be interested in...



Hat Trick For Xofluza As Canadian, Swiss & Australian Regulators Join Forces

Xofluza is also the first non-cancer drug to be reviewed under the Australia-Canada-Singapore-Switzerland (ACSS) Consortium’s work-sharing initiative.

Importation, Pricing Policies Raised Concerns For US FDA's Project Orbis

Allowing multi-regulator collaboration on oncology application assessment may run into pricing issues if Canada and Australia gain access to novel drugs before European countries, US FDA's Pazdur says.

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

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.

Related Content

Topics

Related Companies

Latest Headlines
See All
UsernamePublicRestriction

Register

PS125136

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