District court questions legitimacy of Allergan's patent transfer tactic, saying it 'could spell the end of the PTO's IPR program.'
Allergan PLC argued that its deal with the Saint Regis Mohawk Tribe would block generic drug makers from unfairly getting a second chance to eliminate its Restasis (cyclosporine) patents. But now that a judge has ruled the patents are invalid it may regret trying to derail the inter partes review (IPR) process, since the move may end up resulting only in harm to the firm's reputation.
In an Oct. 16 order, the US District Court for the Eastern District of Texas found that four patents...
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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