In Vivo 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

Problems With Biomarkers: A Tale of Three Drugs

Executive Summary

Enthusiasm for biomarkers to guide drug development and clinical decision making is high, but given how little we know about them, biomarkers are a risky investment, as shown by experiences with EGFR inhibitors.

You may also be interested in...



AstraZeneca’s Soriot Outlines Epanova Approach, Reviews Tough First Year As CEO

AstraZeneca’s two-pronged approach to get its experimental fish oil-based heart drug Epanova approved by U.S. regulators is on track according to CEO Pascal Soriot. But an FDA Advisory Committee’s negative recommendation for Amarin’s similar drug, Vascepa, likely means the second step, seeking a label expansion for Epanova in a broader, less seriously ill population, will have to await full outcomes data.

Companion Diagnostics Move Toward Mainstream Drug Development

With FDA planning to release guidelines on companion diagnostics by year's end, private sector activity around biomarkers appears ready to accelerate. Pharma companies are taking different strategies to incorporate companion diagnostics into their drug development programs, and experimenting with different applications for co-developed products. The relationship between Pharma and diagnostics companies is evolving, with Pharma leading the way. The pace of dealmaking is picking up, but in negotiating partnerships, both sides are still struggling with how to reconcile their different business models, cost structures, and appetites for risk.

Companion Diagnostics Move Toward Mainstream Drug Development

With FDA planning to release guidelines on companion diagnostics by year's end, private sector activity around biomarkers appears ready to accelerate. Pharma companies are taking different strategies to incorporate companion diagnostics into their drug development programs, and experimenting with different applications for co-developed products. The relationship between Pharma and diagnostics companies is evolving, with Pharma leading the way. The pace of dealmaking is picking up, but in negotiating partnerships, both sides are still struggling with how to reconcile their different business models, cost structures, and appetites for risk.

Related Content

Topics

Related Companies

Related Deals

Latest News
See All
UsernamePublicRestriction

Register

IV002553

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