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Keeping Track: Year-End Submissions Rush Brings Seven Novel Agents To US FDA

Executive Summary

Highlights of year-end application submissions including candidates from AstraZeneca, BioMarin, Lilly, MorphoSys, and Seattle Genetics.

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Keeping Track: Quick Trips From Breakthrough Designation To Market

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.

Fast-Track Fail For Kite’s KTE-X19 EU Review?

Priority review is likely in the US for Kite’s second CAR-T therapy offering but it seems the company will have to make do with standard review in the EU. 

US FDA’s 2020 Approvals: A Deep Pipeline, And More Of The Expected

Almost 50 novel agents are already under review at FDA for potential 2020 approval. Candidates are notably diverse, with concentrations in established strongholds (oncology, neuroscience), popular programs (breakthrough), and powerhouse sponsors (keep an eye on Bristol-Myers Squibb right out of the gate).

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