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
How hard (and how) to Pull? Net value of Pull via a Transferrable Exclusivity Extension (TEE)
Chemical vs. drugs (Part 2): How do you discriminate? / More on halicin
FDA: Early endpoints and late endpoints suggest a path to global regulatory convergence (Bart et al.)
Draft EMA antibacterial guidance: Analysis
Draft FDA guidance on anti-infectives for children: It’s (mostly) all about PK and safety
The 37,000-year view: Infections in Eurasia
Plazomicin EU marketing application is withdrawn: Near zero market value of newly approved antibacterials
FDA workshop: Insights on inhaled antifungals and antibacterials
Lessons in Discovery from Lynn Silver + Pro-con on alternatives to antibiotics
Language matters: CRE vs. CPE; SDD vs. I; and MDR, XDR, PDR, UDR vs. DTR
Push! Pull! Push! Pull! / Highlights from Davos 2018
New mechanisms for antibiotic reimbursement in the United States: CMS’s IPPS FY2020 Final Rule
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