A European Commission investigation into Teva’s conduct over its Copaxone multiple sclerosis drug has led to the firm receiving a statement of objections, which details a preliminary finding that the company violated EU antitrust laws.
Teva is prepared to leave no stone unturned in defending itself following the European Commission’s preliminary finding that the Israeli firm breached EU antitrust rules over Copaxone (glatiramer acetate), including by “artificially expanding” the multiple sclerosis treatment’s patent life to delay generic competition.
The commission also alleged that Teva had “systematically spread misleading information about a competing product with a view to hinder...
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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