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

A Tale Of Two Targeted Therapies

This article was originally published in RPM Report

Executive Summary

FDA’s oncology office director suggests Ariad’s ponatinib and ChemGenex’s Omapro represent the best and worst of times, respectively, in the quality of development programs for personalized medicines.

You may also be interested in...



Complexities of Precision Medicine: Managing Multiple Rx/Dx Combos in the Same Class

What happens when multiple targeted therapies are approved by FDA, each with a unique companion diagnostic for the same biomarker? The health care system is ill-equipped to deal with that scenario, putting patients at risk if the wrong test is used to guide a treatment decision. Industry has one solution: an analytical comparison of various diagnostic assays, starting with the anti-PD-L1 immunotherapy class.

Ariad Prepares For Early Launch Of CML Drug Ponatinib

After filing a rolling submission for accelerated approval for wholly-owned Bcr-Abl inhibitor ponatinib in late July, Ariad plans to build a full commercial operation in the U.S. by the end of October.

No Additional Omapro Trials Needed, FDA Tells ChemGenex In Complete Response Letter

FDA reservations mirror those outlined about need for validated assay test at March 22 ODAC meeting.

Topics

Related Companies

Latest News
UsernamePublicRestriction

Register

PS080932

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