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Stark Reminders Of Why Antibiotic Space Remains Unattractive On Display At FDA Advisory Cmte.

 
• By Sarah Karlin-Smith

As need for new antibiotics keeps increasing, a recent US FDA advisory panel offers a case study of why industry isn’t keen on the space. 

Doctor's or scientist's hand holding a microbiological culture Petri dish with different species of bacteria
• Source: Shutterstock

From reimbursement to diagnostics to stewardship challenges and outdated treatment guidelines, the US Food and Drug Administration’s most recent Antimicrobial Drugs Advisory Committee offered an unfortunate reminder about why venturing into the antimicrobial space, despite unmet medical need, is not for the faint of heart.

Key Takeaways

  • Antibiotics advisory panel suggests sponsors need to do more to get new treatments to market – taking more responsibility for stewardship and diagnostic development for instance.

The committee’s message to the sponsor and FDA was largely this: do more, better research, develop tests that can better...

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Precigen’s Papzimeous Approval Allows US FDA CBER Director To Emphasize Flexibility

 
• By Bridget Silverman

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• By Bridget Silverman

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Replimune's RP1 oncolytic immunotherapy became the third regenerative medicine to receive an FDA complete response letter this month as the agency appears to re-visit previous agreements about accelerated approval.

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Slowdown: US FDA’s 2025 Novel Approvals Are On Below-Average Pace

 
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