Pink Sheet Podcast: Insys Divests Opioids, Pretomanid's Advisory Committee Meeting, And Biosimilar User Fee Collections

Our discussion of the Insys corporate integrity agreement and bankruptcy filling, US FDA's advisory committee meeting on the TB treatment pretomanid, and new data showing lower US biosimilar user fee collections than expected.

Topics include preomanid for TB, biosimilar user fees and the Insys corporate integrity agreement.

Senior Writers Derrick Gingery and Michael Cipriano discuss the US federal government's corporate integrity agreement with Insys Therapeutics Inc., which includes a novel provision forcing it out of the opioids business, along with the Antimicrobial Drugs Advisory Committee endorsement of the Global Alliance for TB Drug Development's pretomanid as part of a treatment-resistant tuberculosis regimen. They also cover new financial data indicating the biosimilar user fee program's resources will continue to be volatile.

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More On These Topics From The Pink Sheet

Insys Must Divest Subsys, Buprenorphine Candidate Products As Part Of Corporate Integrity Agreement

Pretomanid Gets Panel Endorsement As Part Of Regimen, Not Individual Molecule, For Treatment-Resistant Tuberculosis

A Tale Of Two Advisory Panels: The Divergent Fates of Pretomanid And Plazomicin

Biosimilar User Fee Collections Drop Well Below Estimates, But US FDA Not Worried