Patent Trial and Appeal Board finds claims in '250 and '413 patents covering 40 mg dosage are unpatentable, giving generic manufacturers a chance at early entry once FDA approves ANDAs.
Teva Pharmaceutical Industries Ltd. could face earlier competition for its 40 mg/mL three-times-a-week dosage of Copaxone (glatiramer) now that the US Patent and Trademark Office's Patent Trial and Appeal Board has determined that two patents covering the product are not patentable.
On Aug. 24, PTAB issued a pair of final written decisions on inter partes review petitions challenging the patents on...
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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