Download Alvin's presentation here for more information on:
The Sparsentan Case Study
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Sparsentan for the Treatment of Focal Segmental Glomerulosclerosis (FSGS)
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Sparsentan–Dual Mechanism of Action
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SparsentanPhase 2 Study –DUET
Accelerated Approval
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What is accelerated approval?
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Success stories: Using AA and biomarkers in rare disease drug development
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What makes for a good biomarker?
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Making the case for proteinuria as a surrogate endpoint
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ETA receptor antagonists have shown reduction of proteinuria in various clinical settings
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Recent advancements on the regulatory front
Find out more about the regulatory pathways in Orphan Drug Research by joining us at the
World Orphan Drug Congress USA 2017
. For example, we have a fantastic Keynote Panel on
Prescription Drug User Fee Act (PDUFA VI) and 21ST Century Cures – recent and pending legislative efforts to make drugs better for patients.