With the Trans-Pacific Partnership multinational trade deal seemingly dead in the water, attention is now turning to potential alternative trade agreements in the Asia-Pacific region. But how might these play out for the global pharma industry?
US President-Elect Donald Trump has declared his intention to issue a formal notification of withdrawal from the Trans-Pacific Partnership (TPP) the day he takes office on Jan. 20, labeling the still non-ratified multinational trade agreement "a potential disaster for our country.”
The US will instead "negotiate fair, bilateral trade deals that bring jobs and industry back onto American shores," Trump declared.
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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