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The development of oncology drugs traditionally begins by studying them in heavily pretreated patients, and then working ‘upstream’ to populations with earlier-stage disease. The recent FDA approval of an androgen receptor antagonist first in prostate cancer patients without demonstrable metastatic disease but at high-risk for metastasis, based on a novel metastasis-free survival end point developed by the FDA, could provide a template for a paradigm shift.
A specialized platform for innovative research exploration — ASPIRE — in preclinical drug discovery could help study unexplored biologically active chemical space through integrating automated synthetic chemistry, high-throughput biology and artificial intelligence technologies.
A panel of independent experts voted narrowly in favour of continuing to require cardiovascular outcomes data for new diabetes drugs, but urged relaxation and simplification of the safety assessment.