Arcapta Quality-Of-Life Benefit For Higher Dose Isn't Enough Given Efficacy Data
Novartis’ experience with its chronic obstructive pulmonary disease drug Arcapta Neohaler is a reminder that while quality-of-life data is nice to have, particularly from a competitive standpoint, it often plays merely a supporting role to clinical efficacy when it comes to product approval.
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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.
