Appeals court to address whether Mohawk Tribe has sovereign immunity before inter partes review proceeding goes forward; Federal Circuit may leave it to Congress to decide question.
The Saint Regis Mohawk Tribe and Allergan Inc. won a stay of inter partes review (IPR) of Restasis (cyclosporine) patents until the US Court of Appeals for the Federal Circuit decides whether the Tribe has sovereign immunity that shields it from the proceedings. However, the delay does not reflect on the ultimate outcome of the dispute and the validity of the patents.
The Mohawk Tribe appealed a February decision by the US Patent and Trademark Office's Patent Trial and Appeal Board (PTAB)...
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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