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Revisiting Accelerated Approval: A Provocative Rebate Proposal

 
• By Michael McCaughan

Formal MACPAC proposal to US Congress to consider enhanced rebates for drugs approved via the Accelerated Approval pathway could have a long shelf life in the context of debates over drug pricing – and over FDA regulatory reforms.

stopwatch and bills
Will faster development mean bigger Medicaid discounts for pharma? • Source: Shutterstock

A new recommendation to Congress from a commission responsible for controlling costs in the US Medicaid program is a very small idea in the context of the broader drug pricing debate – but one that could have larger implications for drug development by prompting a closer look at the Accelerated Approval pathway.

During its April meeting, The Medicaid and CHIP Payment and Access Commission formally endorsed a proposal to set:

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• By Lisa Takagi

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GLP-1 Pricing ‘Paradigm Shift’ Possible, But Would It Meet Trump’s MFN Goals?

 
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EMA Official Clarifies Benefits And Limitations Of Innovation Pathways

 
• By Eliza Slawther

A European Medicines Agency official provided an overview and update of the support the EMA offers developers of innovative products and discussed, among other things, its Innovation Task Force, Quality Innovation Group and a scientific advice pilot for clinical trials.

EU Emergency Response Authority Needs Bigger Budget To Address Health Threats, Says Industry

 
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The EU must renew the mandate of its Health Emergency Response Authority to support medicine stockpiles and enable agile manufacturing to combat antimicrobial resistance and chemical, biological, radiological and nuclear threats, says trade organization EUCOPE.