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

How To Save A Drug After A Negative Panel Review? Narrow The Indication

Executive Summary

Novartis’ multiple myeloma drug Farydak and AstraZeneca’s ovarian cancer treatment Lynparza both fared poorly in their visits to the Oncologic Drugs Advisory Committee, yet they gained accelerated approval after the sponsors – at FDA’s urging – revised the indications to make the benefit/risk profile more attractive.

Topics

Related Companies

Latest Headlines
See All
UsernamePublicRestriction

Register

PS056686

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