Luxembourg will be hosting the UPC’s Court of Appeal and Registry but it is still not clear when or even whether Europe’s new common patent court will be introduced.
While uncertainty continues over when and whether Europe’s Unified Patent Court will come into effect, Luxembourg, which is to host the UPC’s Court of Appeal and Registry, has ratified a key instrument relating to the new system.
Luxembourg has deposited its instrument of approval of the UPC’s Protocol on Privileges and Immunities, which will give legal personality...
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.
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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