Medicines for Europe, the association that represents companies marketing generics, biosimilars and 'value-added' medicines, has called on its members to press the European Commission to introduce a manufacturing waiver for drugs still protected by a supplementary protection certificate (SPC) 'as soon as possible.'
Medicines for Europe, the association that represents companies marketing generics, biosimilars and 'value-added' medicines, has called on its members to press the European Commission to introduce a manufacturing waiver for drugs still protected by a supplementary protection certificate (SPC) 'as soon as possible.'
The waiver, which would allow generics and biosimilars companies to produce versions of products still under SPC protection for export...
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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.
