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Keeping Track: Quick Trips From Breakthrough Designation To Market

 
• By Bridget Silverman

Phase III data earns a breakthrough therapy designation for Resverlogix’ apabetalone; previous companies to follow that strategy swiftly advance to NDA submission, as seen with Novartis’ capmatinib and Seattle Genetics’ tucatinib.

Keeping Track Feature image

While breakthrough therapy designations awarded on the basis of pivotal-stage clinical trial data account for a minority of all BTDs from the US Food and Drug Administration, such products stand out from the recent newsflow around the coveted expedited review designation – and showcase the how the late-stage data that earn BTDs doesn’t need to be entirely positive.

Apabetalone became the latest example of a breakthrough designation awarded on the basis of mature Phase III data when Reserverlogix announced a BTD on 3 February 2020 for the selective...

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• By Bridget Silverman

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US FDA’s Review Performance Held Steady Despite Stormy First Quarter

 
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EU CHMP Opinions And MAA Updates

 
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