Federal Circuit stays injunction that would have halted sales of the PCSK9 inhibitor on Feb. 21; stay extends through appeal of injunction and patent verdict.
Twelve days before a permanent injunction halting sales of Sanofi and Regeneron Pharmaceuticals Inc.’s Praluent (alirocumab) was to go into effect, the US Court of Appeals for the Federal Circuit stayed the injunction pending the outcome of an appeal, which will take several months.
In a Feb. 8 order in the Amgen Inc. v. Sanofi PCSK9 litigation, the court said its...
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.
Joint clinical assessment reports must be descriptive rather than reach definitive conclusions, and must not interfere with national decision making processes, according to new EU guidance.
An effort to change the US Food and Drug Administration’s conclusion that its obesity treatment candidate retatrutide is a drug and not a biologic could give the product more time with unrestricted pricing in Medicare, among other benefits.
Glenmark Pharmaceuticals agreed to pay $25m in the US to resolve its alleged liability under the False Claims Act linked to price-fixing allegations.
It is unclear in a revised staff manual guide whether Commissioner's National Priority Voucher program approval “recommendations” from the drug and biologic center directors will be advisory or decisional, experts told the Pink Sheet.
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.
