Vanda seeks court order requiring US FDA to lift partial clinical hold on its gastroparesis treatment tradipitant; calls on drug makers to oppose agency's animal research policy, saying it requires unjustified killing of dogs.
Vanda Pharmaceuticals Inc. filed suit against the US FDA to get the agency to revoke the partial clinical hold it imposed on its gastoparesis drug candidate tradipitant. But it is also using the complaint to campaign against FDA's animal research policy, saying it results in the unnecessary killing of dogs and other animals.
The company issued an open letter to FDA the day it filed the Feb. 5 complaint, in which...
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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