The tribe will move to get IPR proceedings dismissed, but the strategy isn't expected to affect ANDA litigation. Allergan's CEO said the company could use a similar approach with other patents and notes that other companies may follow.
Allergan PLC stumbled on to its latest intellectual property strategy by chance when a lawyer representing the Saint Regis Mohawk Tribe reached out to the company offering a solution for some of its Restasis (cyclosporine) patent woes. CEO Brent Saunders said it’s a strategy that the company – and its peers – may pursue for other brand-name products.
The lawyer was from the Texas law firm Shore Chan DePumpo LLP, which helped a university claim sovereign status as...
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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