$15.4m fine will resolve claims of "wining and dining" doctors to get them to prescribe Acthar. Mallinckrodt dropped NORD and switched to Chronic Disease Fund to administer its copay assistance program, a move that Mallinckrodt’s COO purportedly described as "mom & pop vs. WalMart."
Mallinckrodt PLC reached a settlement with the US Department of Justice to resolve a portion of the government's claims that it paid kickbacks to boost prescriptions of its H.P. Acthar Gel (repository corticotropin injection). But it is still in litigation over its arrangement with a charitable foundation, which could lead to a much higher payout.
The DOJ announced on 4 September that Mallinckrodt agreed to pay $15.4m to resolve claims that its Questcor Pharmaceuticals...
The US FDA Commissioner pushed for a rebalancing of the US’s pharmaceutical supply chains while also stressing that there is a role for US-China commerce that would be risky to compromise.
A total of 748 key medicines are now affected by the four-month stock requirement, compared with 422 in 2021.
The UK regulator approved 16 medicines containing a new active substance in the first half of this year, while the European Commission issued marketing authorizations for 20 NAS-containing drugs.
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.’
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.
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