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US CDC Leadership Transition Set; Timing Sidesteps Potential Rx Pricing Debate

 
• By Michael McCaughan

President Biden has selected a new director for the US Centers for Disease Control and Prevention, and the pick – former CMS official Mandy Cohen – is likely to be the last who is not subject to confirmation in the Senate. That is an important nuance in the current political climate for drug pricing policies.

US Centers for Disease Control and Prevention building
Legislators will keep an eye on how the new director navigates CDC changes. • Source: Shutterstock

The US Centers for Disease Control and Prevention is set for a major overhaul coming out of the COVID pandemic, and it will have a new leader to oversee the first phases of that project.

President Biden announced 16 June that Mandy Cohen, a former Centers for Medicare and Medicaid Services official who is currently...

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US FDA Could Miss User Fee Spending Triggers With House FY 2026 Funding

 
• By Sarah Karlin-Smith and Derrick Gingery

FDA employees are concerned that while the budget authority total proposed for fiscal year 2026 meets the user fee appropriations' triggers, the FDA could have trouble meeting allocation triggers without cuts to non-review work.

Medicare Part D LIS Access Threatened By House Budget Bill’s Medicaid Obstacles

 
• By Cathy Kelly

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EU authorities must “take advantage” of the upcoming Biotech Act to reassess the bloc’s policies and “offset existing challenges” for small and midsized enterprises, trade association EUCOPE has said.

Argentina Speeds Up Market Access Process

 
• By Francesca Bruce

Companies operating in Argentina may get their medicines to the market more quickly thanks to new updates to the medicines authorization system.

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National Priority Voucher Gives US FDA Commissioner Tool For Radical Regulatory Surgery

 
• By Bridget Silverman

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US FDA’s CoGenT Pilot At Risk? Project Orbis Success May Not Save Cell/Gene Therapy Initiative

 
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HTA Expert Warns Of Escalating Measures If Pharma Fails To Tame Prices

 
• By Francesca Bruce

Too many “uninformative” drug trials fail to justify the excessively high prices of many medicines, while there is too much evidentiary uncertainty in European pricing and reimbursement systems, warned Anja Schiel from Norway’s NOMA.