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Home » Backstory of the FDA lifting its clinical hold and eventual approval of Inrebic
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Sometimes it takes an advocate (or four)

Backstory of the FDA lifting its clinical hold and eventual approval of Inrebic

Feb. 28, 2020
By Brian Orelli
SAN DIEGO – At Biocom's 10th Annual Global Life Sciences Partnering Conference, a panel of players intimately familiar with last year's approval of myelofibrosis treatment Inrebic (fedratinib) explained the backstory of how they got the JAK2 kinase inhibitor off an FDA clinical hold, wrangled the rights to the drug back from the big pharma owner that had acquired the drug from Targegen Inc. and eventually helped the drug gain FDA approval after selling the rights to another large company.
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