Groups weigh in on Tribe's request for Patent Trial and Appeal Board to drop inter partes review of Restasis patents; Deva Holding says pending Allergan infringement suit shows Allergan and Tribe have same interests.
The generic drug industry is aligned with the computer, software and communication industries in opposing the Saint Regis Mohawk Tribe's request that the US Patent Trial and Appeal Board (PTAB) drop an inter partes review of Restasis (cyclosporine) patents.
On the other side, an independent inventor group and five law professors, including constitutional lawyer Laurence Tribe, support the Mohawk...
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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