Suit says FDA wrongly classified the fibrinogen products of three blood centers as ‘blood components’ exempt from clinical trials while classifying Octapharma’s Fibryga as a ‘blood derivative’ subject to clinical studies.
Octapharma USA Inc is seeking an injunction to vacate the US Food and Drug Administration’s approval of plasma-derived fibrinogen products sponsored by three blood centers. It claims they should have undergone clinical testing as the agency required for approval of Octapharma’s Fibryga (human fibrinogen concentrate).
In a 14 September suit filed in the US District Court for the District of Columbia, Octapharma says 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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