Companies in Brazil will not have to provide know-how and other detailed information on patents that are subject to compulsory licenses, although other provisions of a law passed last year to ease the compulsory licensing process remain in place.
Pharmaceutical companies holding medicine patents in Brazil will be pleased to hear that the country’s National Congress has backed President Jair Bolsonaro’s decision to veto parts of a law that would have required firms to provide extensive information on products subject to a compulsory license.
The law (No 14.200/2021), which makes it easier to issue compulsory licenses in the event of a national or international...
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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