The Brazilian medicines regulator, ANVISA, is considering whether to allow generic drug labeling to omit indications of the originator product that are still under patent. "Skinny labels" also figure in an ongoing court case involving Boehringer Ingelheim's Ofev (nintedanib).
Pharmaceutical companies and lawyers in Brazil are still awaiting the outcome of a consultation run by the drugs regulator ANVISA on plans to allow the use of “skinny labels” on generic medicines to avoid potential patent infringement.
The move would change the regulations so that the labeling of generic medicines could omit any indications of the originator...
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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