PTC Therapeutics and Novartis are working on their next steps after the European Medicines Agency recommended against approving their requests to expand the indication of their respective products in the EU.
One and possibly both of the companies who last week failed to persuade the European Medicines Agency to recommend EU approval of their respective indication extension requests will fight on and request a re-examination of their applications.
PTC Therapeutics has said it will appeal and Novartis is considering whether to do so.
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It is unclear in a revised staff manual guide whether Commissioner's National Priority Voucher program approval “recommendations” from the drug and biologic center directors will be advisory or decisional, experts told the Pink Sheet.
Revised recommendation is based on most recent data on circulating strains in US, where KP.3 is now dominant. Novavax sticks with plans targeting the JN.1 ‘parent strain.’
Pink Sheet reporter and editors discuss the US FDA’s changes to the COVID-19 vaccine indication and its revocation of the vaccine emergency use authorizations, as well as new vaccine coverage and reimbursement questions.
