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Latest From Review Pathway
US FDA Pushes Back On Proposal For Early Clinical Designations To Support Higher Reimbursement Decisions
US FDA allowing Sarepta to seek accelerated approval for follow-on DMD agent – following 'precedent' set by eteplirsen. Now the new challenge is to define exactly what that precedent is.
Refining A Controversial Endpoint: Sarepta Banking On Dystrophin Levels For Golodirsen Approval In DMD
Claims such as induction of clinical remission will now be placed in the clinical studies section for new IBD approvals.
Taking on critics who say it is too quick to award accelerated approval based on surrogate endpoints and limited safety data, agency's 25-year review shows cancer drugs receiving accelerated approval generally have twice the amount of safety data as efficacy, and more than half have confirmed clinical benefit after approval.
The first designation of 2018 under the European Medicines Agency’s PRIME scheme has gone to an advanced therapy for patients with the severe eye disorder, achromatopsia. In the meantime, most PRIME applications are still getting rejected.
An unusually large number of companies are due to appear this week before the European Medicines Agency’s key advisory panel, the CHMP, to answer questions about initial marketing authorization applications or indication extension requests. The CHMP has questions regarding nine different products.
Regeneron and Shire should find out this week whether the European Medicines Agency will agree to fast-track its review of their products.
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