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Antibacterial Trials Can Benefit From Futility Analysis, Genentech Tells FDA

 
• By Cathy Dombrowski

Adaptive designs and studies at multiple infection sites are among industry suggestions to the agency as possible new approaches to developing drugs to fight bacterial infections.

FDA should not only allow, but also encourage adaptive or sequential designs for clinical studies of antibacterial drugs, particularly trials that include futility analyses, Genentech Inc. says in comments on an agency request for input on new approaches to antibacterial development.

With the inclusion of a futility analysis, Genentech points out that if a review of all appropriate endpoints finds “that...

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More from United States

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Pink Sheet Podcast: The US and Ex-US Impact Of Most-Favored Nation Drug Pricing

 
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Pink Sheet reporter and editors discuss the potential impact of the Most-Favored Nation drug pricing proposal on Europe, the United States, as well as the pharmaceutical industry.

More from North America

Recent And Upcoming FDA Advisory Committee Meetings

 
• By Sue Sutter

Recent and upcoming US FDA advisory committee meetings and a summary of the topics covered.

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.

PCMA, CVS, Cigna File Lawsuits Over ‘Dangerous’ Arkansas PBM Law

 
• By Tim Casey

The suits are an early test of the Arkansas law banning company ownership of PBMs and pharmacies in the state, as other states consider similar legislation.