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

Genzyme’s Lemtrada Experience Offers Lessons for “Breakthrough” Sponsors

This article was originally published in RPM Report

Executive Summary

When it comes to asking for special attention for priority drug development project, sponsors should remember the old adage, “be careful what you ask for, you just might get it.” Inviting FDA review teams to offer more explicit advice on clinical trial designs can be very helpful, but it also carries the implicit obligation to hew more closely to the advice that FDA gives—or face major complications later on.

You may also be interested in...



Genzyme Will Appeal Lemtrada “Complete Response” After FDA Seeks More Trials

Rater-blinded design for multiple sclerosis claim netted an approval in Europe but a rejection by FDA, which was concerned about bias related to open label studies.

Genzyme Will Appeal Lemtrada “Complete Response” After FDA Seeks More Trials

Rater-blinded design for multiple sclerosis claim netted an approval in Europe but a rejection by FDA, which was concerned about bias related to open label studies.

FDA’s “Breakthrough” Exceeds Expectations; Will It Break The Bank?

Drug sponsors are eager to use FDA’s new “breakthrough” therapy development pathway, and the agency is granting designations at a much faster rate than originally expected. But the “all hands on deck” approach required by FDA officials for breakthrough is resource-intensive at a time when the budget sequestration is preventing the agency from accessing all its available user fee funding. Is the popular program at risk?

Related Content

Topics

Related Companies

Latest Headlines
See All
UsernamePublicRestriction

Register

PS081073

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