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Pink Sheet Podcast: BIOSECURE Act Advances, Trial Diversity Sticks, Platform Principles Without Designation

 
• By Derrick Gingery, Nielsen Hobbs, and Sarah Karlin-Smith

Pink Sheet editors and reporter consider the implications of the BIOSECURE Act as it advances through a House committee, whether industry would improve clinical trial diversity with tougher enforcement of the regulation, as some have suggested, and the FDA’s use of platform technology ideas for gene therapies not participating in the program.

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Would tougher enforcement of regulations improve clinical trial diversity? • Source: Citeline/Shutterstock

Pink Sheet Executive Editor Derrick Gingery, Senior Writer Sarah Karlin-Smith, and Interim Editor in Chief Nielsen Hobbs discuss the implications of the BIOSECURE Act on the pharma industry in the US and China now that the bill that would restrict US government contracting with “biotechnology companies of concern,” as well as the other companies that contract with them, has cleared the House Oversight and Accountability Committee (:30). They also consider some in industry pleading for tougher US Food and Drug Administration enforcement of clinical trial diversity regulations (22:26), as well as the agency’s use of platform technology designation principles for products that do not qualify for the designation (33:07).

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• By Eliza Slawther

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

 
• By Sarah Karlin-Smith and Derrick Gingery

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

 
• By Cathy Kelly

An unintended consequence of a provision framed as an administrative change in the bill could significantly reduce medication adherence among low-income older adults and increase mortality, a study found.

EUCOPE Wants Simpler Manufacturing Rules And Framework For Combined Trials Under EU Biotech Act

 
• By Eliza Slawther

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EMA Explores Supporting Drug Development For High Unmet Need Disorder Scleroderma

 
• By Neena Brizmohun

While treatments for scleroderma are in development, none are approved for the condition that is associated with high morbidity and mortality. The European Medicines Agency says guidance on how to design development programs for the disorder is needed.

EMA Nod For First MASH Drug Rezdiffra, Cell Therapy Zemcelpro And 11 Others

 
• By Eliza Slawther

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BIO Notebook: Policy Uncertainty Constraining Dealmaking

 
• By Mandy Jackson and Joseph Haas

Highlights from Day Four of the BIO International Convention include policy concerns helping constrain dealmaking, Novartis discussing its approach to partnering, and Generate looking for funding to move into Phase III.