The World Health Organization's "unprecedented" decision not to put Novartis's Lucentis on its essential medicines list (EML) for wet AMD, while retaining an unlicensed drug (Roche's Avastin) on the list, sends out a "very unfortunate signal" to industry and regulators, says Richard Bergström, director general of the European industry federation EFPIA.
The World Health Organization's "unprecedented" decision not to put Novartis's Lucentis on its essential medicines list (EML) for wet AMD, while retaining an unlicensed drug (Roche's Avastin) on the list, sends out a "very unfortunate signal" to industry and regulators, says Richard Bergström, director general of the European industry federation EFPIA.
The EML helps countries – especially developing ones – to decide which products they should purchase to address their priority...
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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.
