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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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US FDA’s Familiar Drug Pricing To-Do List

 
• By Michael McCaughan

President Trump’s new Executive Order on drug pricing reprises several policy themes from his first administration, including giving the FDA many tasks intended to increase competition in the marketplace.

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US Most Favored Nations Policy: Higher Drug Spending In Germany Is ‘Difficult To Imagine’

 
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Japan Reimburses 11 New Drugs But Slashes Price Of Others By Up To 20%

 
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Japan's NHI program continues to give and take as 11 new drugs are granted reimbursement, while the prices of others - including three ophthalmic therapies - are cut by up to 20% under a Market Expansion Repricing scheme.

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EU To Track Decentralized Clinical Trials In CTIS To Support Innovation

 
• By Vibha Sharma

Monitoring the use of decentralized elements in clinical trials is a priority for the European medicines regulatory network.

Why Hympavzi Secured English Funding For Hemophilia B But Not Hemophilia A

 
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Europe’s UPC Issues Landmark Ruling On Second Medical Use Claims

 
• By Neena Brizmohun

The verdict by the Unified Patent Court in the dispute between Sanofi/Regeneron Pharmaceuticals and Amgen explains what companies should look out for when deciding whether infringement has taken place when it comes to second medical use patents.