Settlement is first involving a copay assistance program operated through Caring Voice Coalition since the HHS Office of Inspector General rescinded a safe harbor for the charity's activities in late November. Is it the first of a wave?
United Therapeutics Corp. has settled Department of Justice charges that it violated the False Claims Act and anti-kickback laws with the copay assistance it provided to Medicare beneficiaries. As part of the settlement, United Therapeutics is accepting a $210m fine and conceding to a corporate integrity agreement.
The settlement was announced Dec. 20 by the Department of Justice in conjunction with the US Attorney's Office...
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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