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
FDA: Early endpoints and late endpoints suggest a path to global regulatory convergence (Bart et al.)
In Praise of Non-Inferiority
Draft EMA antibacterial guidance: Analysis
New mechanisms for antibiotic reimbursement in the United States: CMS’s IPPS FY2020 Final Rule
Plazomicin EU marketing application is withdrawn: Near zero market value of newly approved antibacterials
NIAID workshop: What is a robust PK-PD package?
IDSA White Paper on developing narrow-spectrum antimicrobials + editorial by G. Drusano
Plazomicin (Achaogen) financial post-mortem: #PassPASTEUR
Two new oral drugs for gonorrhea!
The 6 meanings of “Lack of Access” (UNSLAP)
FDA workshop: Insights on inhaled antifungals and antibacterials
COVID-19 and the Long-Term Trajectory of AMR Efforts: Wellcome Trust Deep Dive
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