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


A Peak Year For Drug Approvals, But Can R&D Keep Up With FDA?

This article was originally published in RPM Report

Executive Summary

FDA topped 40 new molecular entity approvals in 2014, leaving no doubt that the agency’s drug review group is operating at peak efficiency. But it is still far from clear that drug development is out of the doldrums.

You may also be interested in...

Two Steps Forward, One Step Back: FDA, Actavis Antibiotic Plan Goes A Bit Too Far For Committee

FDA continues to reshape the antibiotic regulatory pathway, both in word and in deed. The latest example of a collaborative, push-the-envelope review included a novel Actavis antibiotic formulation where FDA seemed ready to approve the drug without any human data. That was one step too far for the agency’s advisors.

What Makes A “Breakthrough”?

FDA is still not ready to draw any clear line defining what qualifies for the new “Breakthrough” therapy designation, but most successful applicants have presented data showing more than a 50% improvement versus standard therapy on some important endpoint.

Gilead Puts High Premium On Priority Review Voucher; Deal May Help Protect Lead In HCV

Gilead pays $125 million for the right to a faster review of a future product, doubling the price paid in the first priority review voucher sale just months before. The value of the voucher may go up if pending legislation is signed into law – but the high price tag speaks volumes about the importance of maintaining the lead in Hep C formulation development.

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