The DC Circuit Court agrees with an earlier appeals court ruling that the law does not prohibit manufacturers from setting the terms of their 340B outpatient drug discounts to contract pharmacies.
The US Court of Appeals for the District of Columbia concluded Novartis AG and United Therapeutics Corporation did not violate the 340B outpatient drug discount program law by imposing restrictions on pharmacies dispensing drugs under contract with hospitals and other health care providers participating in the program.
The decision issued 21 May affirms a lower court decision in favor of the drug companies and against the US...
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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