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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.

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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.

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