Agency restores long dormant enforcement of section of FTC Act prohibiting businesses from using ‘unfair methods of competition,’ expanding types of corporate behavior subject to enforcement action.
Biopharmaceutical companies could face new enforcement actions by the US Federal Trade Commission now that the agency is pursuing violations of Section 5 of the FTC Act. The section targets “unfair methods of competition,” which encompass a broader range of conduct than the FTC may pursue under the Sherman and Clayton Acts.
On 10 November, the FTC issued a new policy statement on the scope of unfair methods of competition under...
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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