Apotex wants Supreme Court to say that firm doesn't have to wait until FDA licensure of its pegfilgrastim and filgrastim biosimilars to provide Amgen 180-day notice of commercial marketing; Solicitor General has yet to weigh in on similar Sandoz petition.
Apotex Inc. has followed Sandoz in urging the Supreme Court to review an appeals court ruling that delays the launch of a biosimilar until six months after FDA licensure.
Apotex filed a petition on Sept. 9 challenging the US Court of Appeals for the Federal Circuit's decision...
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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