Faced with the prospect of a compulsory license in Malaysia, Gilead has reviewed its generic licensing agreements to grant access to low-cost versions of its HIV and hepatitis C drugs in the country and three other middle-income nations.
Gilead Sciences’ decision to expand a licensing agreement that will allow generic companies to sell low-cost versions of its HIV and hepatitis C generic drugs in Malaysia, Thailand, Ukraine and Belarus has drawn a muted response from medicine access campaigners.
The company is being accused of taking this long overdue “positive step for patients” under pressure from the Malaysian government,...
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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