A total of 748 key medicines are now affected by the four-month stock requirement, compared with 422 in 2021.
The French regulator, ANSM, has imposed fines totaling almost €8m ($9m) on 11 pharmaceutical companies for failing to meet their obligations to hold a minimum of four months’ stock of certain medicines of “major therapeutic interest” (MMTIs).
The fines, which are part of a government drive to prevent and address shortages of key drugs, show a sharp...
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 will require all antibiotic manufacturers looking to apply for funding under its subscription payment model to demonstrate they are meeting waste discharge standards in a bid to reduce antimicrobial resistance.
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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