Johnson & Johnson has reached an agreement with the Stop TB Partnership that will allow generic bedaquiline versions of the firm’s Sirturo brand to be supplied in low-and middle-income countries where patents remain in effect – but critics say the deal does not go far enough.
Under a deal struck by Johnson & Johnson and the Stop TB Partnership, generic versions of J&J’s Sirturo (bedaquiline) tuberculosis treatment will be able to be supplied in low-and middle-income countries despite existing intellectual property for the brand.
Announcing the agreement – which came “following lengthy negotiations” – the Stop TB Partnership, which is a United Nations hosted...
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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