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Jardiance Mortality Claim Narrowly Endorsed By FDA Advisory Committee

 
• By Sue Sutter

The 12-11 vote supporting new indication for reduced incidence of cardiovascular death provides cover for FDA if it decides more data are needed before granting first CV benefit claim to a diabetes drug.

Strong mortality data lifted Boehringer Ingelheim GMBH and Eli Lilly & Co. to a positive FDA advisory committee review of a cardiovascular benefit claim for Jardiance (empagliflozin), but the panel's closely split vote likely means the question is far from settled for FDA.

At a June 28 meeting, the Endocrinologic and Metabolic Drugs Advisory Committee voted 12-11 that results from the EMPA-REG OUTCOME trial provide substantial evidence to establish that the

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• By Sarah Karlin-Smith

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Smoldering Myeloma Endpoint Questions Carry J&J’s Darzalex Faspro To US FDA AdComm

 
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• By Sue Sutter

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Califf In Conversation: ‘Decimated’ US FDA Teams Endanger Innovation

 
• By Barnaby Pickering

Pink Sheet sister publication In Vivo spoke to the former FDA commissioner about the recent layoffs and their impact on vaccine and other product development.

More from North America

‘Tectonic’ Arkansas PBM Legislation May Upend Industry

 
• By Tim Casey

Industry will fight hard to prevent other states or the federal government from adopting measures similar to Arkansas' law preventing PBMs from owning pharmacies.

Will International Prices Influence Medicare Price Negotiation?

 
• By Cathy Kelly

A former CMS official suggested the most likely way it could happen is through a Center for Medicare and Medicaid Innovation demonstration.

US FDA Vaccine Framework Coming In Weeks, But Details Vague

 
• By Sarah Karlin-Smith

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