Amgen’s dazodalibep has met the primary endpoint in the Phase 3 OASIZ 301 study, improving systemic Sjögren’s disease activity as early as Week 4 and sustaining the benefit through Week 48. The result is a major step in a disease with no FDA-approved systemic treatment specifically for Sjögren’s, but Amgen has not yet disclosed the
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FDA review is moving closer to real time. Paradigm Health’s pilot with Amgen and AstraZeneca could reset clinical trial infrastructure.