Taking The Temperature Of Accelerated Approval: An Interview With Ariad's President Of R&D Tim Clackson (Part 1 Of 2)
This article was originally published in The Pink Sheet Daily
R&D head talks about the company's lead candidate ponatinib's developmental plan under accelerated approval.
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After filing a rolling submission for accelerated approval for wholly-owned Bcr-Abl inhibitor ponatinib in late July, Ariad plans to build a full commercial operation in the U.S. by the end of October.
With positive signs for its stable of cancer drugs, including an imminent filing for the sarcoma candidate ridaforolimus, Ariad Pharmaceuticals Inc. is nearing the turning point from a development to a commercial company.
FDA plans to hold a yearly session with its Oncology Drugs Advisory Committee on cancer drugs granted accelerated approval as a means of holding sponsors' feet to the fire with regard to conducting confirmatory trials.