KEI vows to continue battle over Bayh-Doyle restrictions after US Commerce Department suggests it may issue regulations to exclude pricing as a basis for requiring companies to license their patents.
The US Department of Commerce has left unresolved the exact circumstances in which the federal government can require a patent owner or licensee to share its patent rights with another party, but its suggestion that drug pricing is not likely to be a factor for pharma patents will surely drive further debate over the issue before regulations are implemented.
On 24 April, the Commerce Department's National Institute of Standards and Technology (NIST) issued a final Green Paper addressing the...
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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