US HHS Office of Inspector General clears company program to provide travel expenses and lodging to needy patients located far from designated treatment centers.
Novartis AG’s program to help needy patients or those living in rural areas pay for travel and lodging costs associated with administration of its Kymriah will not incur penalties or sanctions under the US federal anti-kickback statute, the Department of Health and Human Services Office of Inspector General has concluded.
“Although the arrangement could potentially generate prohibited remuneration under the anti-kickback statute if the requisite intent to induce or reward...
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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