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

FDA On Personalized Medicine: Don’t Skimp On Diagnostic Quality Development

Executive Summary

A Center for Devices and Radiological Health representative tells a conference on drug/diagnostic co-development that it doesn’t matter how well designed a study for a therapeutic agent is if the accompanying biomarker-targeted test is not reliable and uniformly implemented.

You may also be interested in...



Teva’s Synribo: Salvage Therapy, But Not Personalized Medicine

Omacetaxine finds new life as a salvage treatment in chronic myeloid leukemia after failing to pass FDA muster for targeted therapy in patients with a particular genetic mutation. FDA allowed Teva to pool data from two open-label studies to secure approval in a third-line setting.

Enrichment Guidance To Prod Sponsors Toward Prospective Patient Stratification

The sensitivity and specificity of the target identification could determine size of the off-target population, CDER senior statistical advisor Robert O’Neill says at DIA/FDA meeting on revitalizing R&D.

Can Erbitux Make Inroads In First-line Colon Cancer With Approved Companion Dx In Tow?

Erbitux wins FDA approval for first-line metastatic colorectal cancer negative for KRAS mutations detected with a companion diagnostic specifically approved for the drug. In theory, earlier use could help shore up sales. But the drug faces a tough competitor in the dominant Avastin and new products are on the near horizon.

Related Content

Topics

Related Companies

Latest News
See All
UsernamePublicRestriction

Register

PS054757

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