Legal experts testify that best option is for all decisions of the Patent Trial and Appeal Board to be reviewed by PTO director; House IP subcommittee wants to restrict ruling that PTAB judges were not constitutionally appointed.
An appeals court ruling altering the status of Patent Trial and Appeal Board (PTAB) judges has caused such an uproar among patent owners that the House Judiciary Subcommittee on Courts, Intellectual Property and the Internet called a hearing to ask legal experts what Congress can do to provide a legislative fix.
The four witnesses who testified agreed that the best option would be for Congress to require that all decisions made...
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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