FDA Panel Finds Animal Models Predict Human Response To HGS Anthrax Drug
Animal model results for Human Genome Sciences' raxibacumab are predictive of the biologics' ability to treat inhalation anthrax in humans, FDA's Anti-Infective Drugs Advisory Committee concluded Oct. 27, but FDA should request more evidence on whether the monoclonal antibody adds benefit to treatment with antibiotics alone
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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.
