Patent office requests comments on its proposed initiatives, with continuation patents appearing a particular target. PTO asks if filing a terminal disclaimer for patents that are a variation of each other should be an admission they are obvious.
The US Patent and Trademark Office is seeking public comments on its proposed initiatives to ensure that patents are not being used to improperly delay competition. The agency set forth a list of questions which flesh out the agency’s ideas and indicate sponsors may have to do more to get a patent issued.
The request for comments, published in a 4 October Federal Register notice, focuses on continuation applications, which have been...
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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