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

The Next Phase In Oncology: FDA’s Pazdur Has New Vision For Drug Development

Executive Summary

FDA’s top cancer drug reviewer has taken to the podium to paint a picture of the next phase in cancer drug development, which includes new business models, a return to single-arm trials and a new emphasis on safety.

You may also be interested in...



Tissue-Agnostic Approach To Cancer Drug Development Takes A Hit

Roche's VE-BASKET trial based treatment on biomarkers instead of the tissue of origin, but it ended up reinforcing the importance of conventional tumor histology in drug development as a complement to new molecularly targeted approaches. Now, eyes are on Novartis' ambitious SIGNATURE program to confirm the signal-finding potential of the basket trial approach.

In Brief: Bristol’s Nivolumab Shows Survival, Boehringer Gains A Breakthrough & Sentinel Takes On Flu Vaccines, Plus CHMP Opinions

Bristol’s early stop of a nivolumab trial in melanoma offers the first late-stage, randomized survival data for the PD-1 class; Boehringer’s Pradaxa antidote is on the breakthrough track; CHMP clears Bristol’s daclatasvir ahead of FDA; and FDA concludes flu vaccines aren’t linked to seizures.

FDA Often Looks Outside The Application, Review Documents Show

A look back at drug reviews in the past year illustrates the many ways FDA takes external factors into consideration when reviewing an application – from guiding trials to look for certain class safety signals to finding support for a particular endpoint.

Related Content

Topics

Related Companies

Latest News
See All
UsernamePublicRestriction

Register

PS055742

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