The progression-free survival metric has helped shepherd many products across the regulatory finish line. Experts say the FDA’s new emphasis on overall survival will be felt especially by small biotechs.
Also called an umbrella or basket trial, the master trial allows for a more targeted approach to cancer treatment, faster patient enrollment and the flexibility to pivot.
With recent high-profile failures, experts say safety concerns and a lack of diversification are hindering the field—but still hold out hope for an approval.
After a groundbreaking year in the Alzheimer’s space, Parkinson’s disease researchers express renewed hope based on a greater biological understanding of neurodegeneration.
