Gilead sought the US Trade Representative's intervention to halt sofosbuvir compulsory license, while Pfizer complained about Malaysia regulation requiring disclosure of prices throughout the pharmaceutical supply chain.
Pfizer Inc. and Gilead Sciences Inc. communications with the US Trade Representative show the companies' efforts to quash measures in Malaysia deemed harmful to the pharmaceutical industry, according to a series of communications obtained under the Freedom of Information Act by the nongovernmental organization Knowledge Ecology International (KEI).
KEI released the emails between the USTR and both companies in Nov. 28 and 29 blog postings. Pfizer's communications...
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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