Brilinta's North America Anomaly Stymies AstraZeneca, Worries Analysts
Questions surrounding a subanalysis of PLATO data showing that AstraZeneca's experimental antiplatelet drug Brilinta (ticagrelor) apparently didn't help North American acute coronary syndrome patients center not on whether the observation is valid, but on what FDA's reaction will be
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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.
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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.
