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Antibiotics Pipeline Is Lively, But Sponsors Are Fragile

 
• By Bridget Silverman

Regulatory uncertainty could imperil the crop of emerging companies making a go of it in the incentive-laden US anti-infective space.

Ski gates
Navigating the regulatory environment for antibiotics is a challenge • Source: Shutterstock

The global response to the antimicrobial resistance crisis has seen success using incentives to attract new specialty companies into the scientifically difficult and commercially unattractive infectious disease space, but now the young crop of sponsors with late-stage candidates must overcome a challenging regulatory environment in the US – and not all can be expected to succeed.

FDA has issued more than 100 designations to more than 60 product candidates under the Qualified Infectious Disease Product (QIDP) designation, an expedited review program akin to the breakthrough therapy designation

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