USTR's 2018 Special 301 Report moves two countries to Priority Watch List in part because of their pricing policies; AAM says focus should be on government reimbursement rather than extending IP protection.
Ahead of President Trump's anticipated announcement on drug pricing, the US Trade Representative released its annual report admonishing US trading partners deemed to have inadequate intellectual property rights protection. A major focus this year is on pricing and reimbursement policies for pharmaceutical products.
But while the spotlight in the US is on reducing drug prices, the USTR's2018 Special 301 Report criticizes countries...
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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