After the Medicines Patent Pool secured a licensing deal with ViiV Healthcare for long-acting injectable cabotegravir for HIV pre-exposure prophylaxis, prospective generic sub-licensees have until 4 September to submit expressions of interest.
The Medicines Patent Pool and ViiV Healthcare have struck a voluntary licensing deal that will allow MPP partners to develop, manufacture and supply generic versions of long-acting injectable cabotegravir for HIV pre-exposure prophylaxis in 90 low-income, lower middle-income and Sub-Saharan African countries.
“This announcement comes just seven months after the first regulatory approval of cabotegravir LA for PrEP in the world, by...
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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