ANTIMICROBIAL RESISTANCE SOLUTIONS
WITH DR. JOHN H. REX
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R&D Insight
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Antimicrobial resistance poses a catastrophic threat. If we don’t act now, any one of us could go into hospital in 20 years for minor surgery and die because of an ordinary infection that can’t be treated by antibiotics. And routine operations like hip replacements or organ transplants could be deadly because of the risk of infection.
Dame Sally Davies Tweet


















Categories of resistance: MDR, XDR, PDR, UDR, and (new!) DTR
News from Davos 2020: Some positive signs, but overall a fragile antibiotic market at a tipping point
Plazomicin (Achaogen) financial post-mortem: #PassPASTEUR
How hard (and how) to Pull? Net value of Pull via a Transferrable Exclusivity Extension (TEE)
The hunt for oral antibiotics: Beyond Lipinski’s Rule of Five
New mechanisms for antibiotic reimbursement in the United States: CMS’s IPPS FY2020 Final Rule
In Praise of Non-Inferiority
Novel Biology, Novel Utility, & the Illusion of Skill: What to develop? What to reward?
FDA Workshop: Animal models in support of narrow-spectrum agents for A. baumannii and P. aeruginosa
The 6 meanings of “Lack of Access” (UNSLAP)
Draft FDA guidance on anti-infectives for children: It’s (mostly) all about PK and safety
FDA: Early endpoints and late endpoints suggest a path to global regulatory convergence (Bart et al.)
The thoughtless person playing with penicillin treatment is morally responsible for the death of the man who succumbs to infection with the penicillin-resistant organism.
Alexander Fleming Tweet

The bipartisan PASTEUR Act is the strongest bill ever written to strengthen antibiotic development and use. It will fix our market failures, expand the pipeline for next generation antibiotics, and save lives. We can’t sit on our hands as this public health crisis arrives – we have to act now.
U.S. Senator Michael Bennet Tweet