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

Ariad’s Leukemia Drug Iclusig Sails Through FDA In Less Than 3 Months

Executive Summary

Ponatinib received accelerated approval for use in chronic myeloid leukemia and acute lymphoblastic leukemia patients who are resistant or intolerant to prior therapy with tyrosine kinase inhibitors.

You may also be interested in...



Insider Trading: Ex-Ariad Staffers Charged With Using FDA Info On Iclusig

Former directors of pharmacovigilance and risk management agree to pay disgorgements and civil penalties in SEC complaints charging them with trading in Ariad stock in advance of FDA announcements about the leukemia drug Iclusig.

With Iclusig’s Return, Ariad Gets A Second Chance To Get The Dose Right

In allowing ponatinib back on the market, FDA is requiring the sponsor to address a gap in the original development program – failure to identify the optimal dose. However, Ariad is also looking at the post-marketing requirements as a step in the pathway to use in earlier treatment settings.

Iclusig Returns To Market With Smaller Patient Population, Stronger Warnings

FDA approves new labeling that narrows the indication for Ariad’s leukemia drug to largely the third-line and later setting.

Related Content

Topics

Related Companies

Latest News
See All
UsernamePublicRestriction

Register

PS054968

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