In an unusual twist, district court ruled Acorda patents invalid after company defeated Kyle Bass' inter partes review challenge; Bass has won 10 IPR decisions, lost 9 and has one pending.
Acorda Therapeutics Inc.'s celebration in defeating Kyle Bass' challenge of its Ampyra (dalfampridine) patents in inter partes review (IPR) proceedings was short-lived as a district court found them to be invalid, clearing the way for possible generic entry in July 2018. The different outcomes show the perils of both pathways for patent owners.
In a March 31 opinion, US District Court for the District of Delaware Judge Leonard Stark ruled that...
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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