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A Breakthrough Therapies Pathway In Europe? Not Likely, Regulators Say

This article was originally published in RPM Report

Executive Summary

Drug companies looking for a FDA-style Breakthrough Therapies pathway in Europe shouldn’t hold their breath: The current European health care reimbursement landscape, regulators say, cannot support a Breakthrough pathway. Europe is looking for other ways to shorten drug development times until the bigger-picture reimbursement question can be addressed. Is adaptive licensing the answer?


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