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

Pfizer’s Bosulif Will Face Competitive Market In Second-Line CML

Executive Summary

Approved by FDA Sept. 4, bosutinib will face off against two established tyrosine kinase inhibitors in the post-Gleevec treatment setting: Bristol’s Sprycel and Novartis’ Tasigna. Pfizer is highlighting Bosulif’s “distinct adverse event profile” and single-daily dosing to its advantage.

You may also be interested in...



Pfizer Bases Bosutinib U.S. Filing On One Single-Arm Phase II Trial

Pfizer’s NDA for dual Src and Abl inhibitor bosutinib in previously-treated Philadelphia chromosome-positive CML bypassed the failed first-line Phase III BELA trial. In Europe, BELA is the basis of a pending front-line CML application.

Clinical Trial Diversity Requires Sponsors Work With An Assortment Of Patient Advocates, Community Organizations

US FDA oncology officials are concerned that the entities sponsors are consulting in developing and implementing clinical trial diversity plans are not sufficiently diverse themselves and do not represent patients in underserved communities.

US FDA Drugs Center Launches Clinical Trial Innovation Hub With Demonstration Projects

CDER’s Center for Clinical Trial Innovation (C3TI) will support innovative clinical trial approaches designed to improve the quality and efficiency of drug development and regulatory decision-making. The initiative includes demonstration projects on Bayesian analyses, selective safety data collection and point-of-care trials.

Topics

Related Companies

Latest Headlines
See All
UsernamePublicRestriction

Register

PS054733

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