The European Commission has mounted a robust defence of its decision not to approve an orphan drug from a French company against the advice of the European Medicines Agency's scientific committee, the CHMP, and the standing committee of member state representatives1.
The European Commission has mounted a robust defence of its decision not to approve an orphan drug from a French company against the advice of the European Medicines Agency's scientific committee, the CHMP, and the standing committee of member state representatives1.
Addressing members of a European Parliament committee on 21 June, Patricia Brunko, head of the commission's pharmaceuticals unit, said that...
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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.
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