“Orange Book” Listings Are Not Immune From Antitrust Scrutiny, FTC Says
"Orange Book" patent listings should not be afforded the same antitrust exemption given to "petitioning," the Federal Trade Commission maintains in an amicus curiae brief filed as part of a state attorneys general action against Bristol-Myers Squibb
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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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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.’
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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.
