Innovators say case before court could upend ANDA litigation by preventing consolidation of cases; Genentech sees potential impact on biosimilar suits.
The US Supreme Court is to hear a dispute between two food companies that could restrict where biopharma companies can file patent infringement suits. The brand-name industry is urging the court not to limit the venue while the generic drug industry is advocating for restrictions on where they are sued.
At issue in the case, TC Heartland LLC v. Kraft Foods Group Brands LLC, is the interpretation of the patent...
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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