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...
Despite following the path of the popular Project Orbis, the cell and gene therapy international collaborative review pilot is being reconsidered by the FDA's new management.
It appears that the European Medicines Agency is making progress on its re-examination of Eli Lilly’s Alzheimer’s disease drug Kisunla, following an initial rejection in March based on safety concerns.
Key expert panel go-ahead with a trial waiver put’s Eisai's Alzheimer's therapy on track for a debut in India where tailored pricing will be pivotal. Lilly’s Kisunla is also under regulatory review.
