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510(k) Archives

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Food & Drug Administration (FDA) Archives

Food & Drug Administration (FDA) Archives
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Merck (MRK) and AstraZeneca (AZN) Present Final Results of Key Secondary Overall Survival Endpoint From Phase 3 PROpel Trial

Merck (MRK) and AstraZeneca (AZN) Present Final Results of Key Secondary Overall Survival Endpoint From Phase 3 PROpel Trial
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Transferable exclusivity voucher: a flawed incentive to stimulate antibiotic innovation

As antibiotic resistance increases globally, antibiotic innovation is struggling. WHO states that the antibiotic clinical pipeline is “insufficient to tackle the challenge of increasing emergence and spread of antimicrobial resistance”.1 To prevent the development of resistance, new antibiotics are used as last resort treatments and, if properly used, have small patient populations, resulting in fairly low sales revenues for industry.

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