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US FDA Must Explain How It Defines ‘Innovation’ In Awarding Hatch/Waxman Exclusivity, Court Says

 
• By Sue Sutter

Agency's decision that Indivior’s Sublocade blocked Braeburn’s long-acting buprenorphine formulation Brixadi lacked ‘substantive guideposts’ in how innovation is defined for purposes of deciding scope of three-year exclusivity, US judge says.

Boxing-ring-bell
Round 1 goes to Braeburn in its legal boxing match with the FDA and Indivior over Brixadi. • Source: Shutterstock

The US Food and Drug Administration must set forth a standard by which a drug’s “innovation” is defined in determining whether Hatch/Waxman new product exclusivity blocks approval of a subsequent product, a US federal judge has ruled in a dispute related to buprenorphine depot injection formulations.

The agency’s decision that the monthly formulation of Braeburn Pharmaceuticals Inc.'s Brixadi (buprenorphine extended-release injection) cannot be approved until...

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US FDA Teases Disclosure Program, But Industry Has Seen This Before

 
• By Derrick Gingery

Center for Biologics Evaluation and Research Director Vinay Prasad said Commissioner Martin Makary wants to release previously inaccessible FDA documents, but previous commissioners have made the same pronouncements only to make little progress.

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• By Tim Casey

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• By Urtė Fultinavičiūtė

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• By Eliza Slawther

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Recent And Upcoming FDA Advisory Committee Meetings

 
• By Sue Sutter

Recent and upcoming US FDA advisory committee meetings and a summary of the topics covered.

UK-Wide Strategy Needed To Move Clinical Trial Diversity Plans To Next Stage

 
• By Vibha Sharma

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Blenrep’s Comeback Continues As England Becomes First To Fund Drug

 
• By Eliza Slawther

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