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


Farydak Confirmatory Trial To Come Years After Accelerated Approval

Executive Summary

Despite the agency’s preference that confirmatory trials generally be under way at the time of accelerated approval, Novartis’ panobinostat Phase III trial isn’t expected to begin for approximately three years.

You may also be interested in...

FDA Used Regulatory Loophole To Save Novartis' Farydak

FDA shoehorned third-line multiple myeloma therapy into accelerated approval program using loophole in concept of unmet medical need; maneuver also gave agency ability to define a do-over of development plan.

Cost-Benefit Of Early Access To NSCLC Drugs Evaluated In JAMA Study

Researchers from University of California and Novartis present a framework for evaluating the social benefits of early access to new treatments on the basis of progression-free survival.

Accelerated And Accompanied: Oncology Drugs Should Use Randomized Trials, FDA Panel Says

Single-arm studies for accelerated approval should be used only when the patient population is small or drug activity is high, the Oncology Drugs Advisory Committee says.

Related Content


Related Companies

Latest Headlines
See All



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