Dust has barely settled around the uncertainty stirred up by the Federal Trade Commission’s view of the Amgen/Horizon merger and now the US regulator is taking another surprising action.
A cautious optimism had settled over the pharmaceutical industry’s thinking on the regulatory outlook for deals after the US Federal Trade Commission reached an agreement with Amgen, Inc. to allow its planned merger with Horizon Therapeutics to close.
But now the agency has suddenly turned on the industry again with another surprising action, raising new questions for deal...
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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