Patent Bill Drama Moves To House As Senate Hands Brand Pharma Victory
With the Senate poised to approve its version of the patent reform bill, House Judiciary Committee Chairman Lamar Smith, R-Texas, will soon be in the driver's seat of a piece of legislation that could significantly alter the relationships pharmaceutical companies have with both their licensing partners and generic adversaries.
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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.




