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STAT+: Generic GLP-1 drugs could help Medicare drive a harder bargain for Ozempic and Wegovy

STAT

The advent of the first generic GLP-1 drugs could help Medicare negotiate a lower price for the highly sought after diabetes and obesity medication semaglutide , according to experts familiar with the price-negotiation program and STAT’s review of documents from the first round of negotiations.

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STAT+: Tennessee officials find Express Scripts violated law governing commercial pharmacy claims

STAT

In an unusual move, an audit of commercial health plans by Tennessee officials found that Express Scripts, one of the largest pharmacy benefit managers in the United States, violated state laws in its dealings with pharmacies, according to newly released documents.

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STAT+: Eleos raises $60 million for AI scribe for behavioral health providers

STAT

The rise of large language models that can efficiently summarize text has fueled the rapid development of companies using the technology to take documentation burden off overworked clinicians. Then, the provider must go through and add or edit the text that the Eleos software generated to their final note.

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The Great RIF(T): One FDA Division’s Destruction and What it Could Mean for Generic Drugs

FDA Law Blog: Biosimilars

Indeed, since 2014, DPD facilitatedthe publication of 42 quarterly batches and dozens of stand-alone PSGs, plus three one-off batches of PSGs updated to align with recommendations in general guidance documents ( g. , Under GDUFA III alone, DPD published 32 GDUFA guidance documents and MAPPs to ensure the successful implementation of GDUFA.

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Opinion: AI scribe technology lets me focus on my patients, not a screen

STAT

Two decades ago, when I first began practicing emergency medicine, patient documentation was a manual process. I would write on carbon-copy forms that were later stored in the belly of the hospital, in archives, as patient files.

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Abridge raises $250 million highlighting ‘billable notes’

STAT

Abridge, which has emerged as one of the leaders amid the boom in companies using technology to streamline clinical documentation, announced today it has over 100 health system customers, including big names like Duke Health, Johns Hopkins, and Mayo Clinic. Read the rest…

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Reports Document FDA Review Delays: What Drugmakers Should Know Now

FDA Law Blog: Biosimilars

By John W.M. Claud & Michelle L. Butler Recent reductions in force (RIFs) and leadership changes at FDA are already affecting key agency functionsand as the administration plans a broader reorganization, the impact will likely grow. One area drawing increasing attention is how these changes will affect the drug development and review process.