Upcoming White House report on antibiotic incentives will provide a strong endorsement of one-time payments to reward successful development of new therapeutics. That is a mixed blessing for advocates for legislative action for incentives who are focusing on 'wildcard' patents.
President Donald Trump has placed special emphasis on reversing initiatives directly associated with his predecessor, but one important Obama era executive order for the biopharma sector has – so far at least – remained in effect: the initiative to combat antibiotic resistance.
In particular, the Presidential Advisory Council on Combating Antibiotic-Resistant Bacteria (PACCARB) is wrapping up work on a report on incentives...
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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