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

 
• By Kate Rawson

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?

The relationship between the Food & Drug Administration and its regulatory counterpart in Europe, the European Medicines Agency, could be characterized as a friendly competition between two peers.

FDA considers it a point of pride when new therapies are available to U.S. patients before other countries, and agency officials often highlight the number of drugs that are approved...

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