It’s that time of the year when Indian and US firms lock horns around all things IPR [intellectual property rights] ahead of the USTR’s annual Special 301 report. Indian pharma firms want India off the USTR’s Priority Watch List, while PhRMA says it remains concerned about the challenging policy environment and weak patent enforcement in India.
Frontline Indian pharmaceutical firms want the United States Trade Representative (USTR) to take India off the Priority Watch List in its annual Special 301 Report in view of the “strides” made towards an improved intellectual property rights (IPR) regime and to sustain this “forward momentum”.
These firms claim that “administrative improvements” in patent issuance and enforcement demonstrated in 2015 and 2016 have been sustained and...
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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