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
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.)
Melinta goes bankrupt / Never let a good crisis go to waste
Draft FDA guidance on anti-infectives for children: It’s (mostly) all about PK and safety
Draft EMA antibacterial guidance: Analysis
NIAID workshop: What is a robust PK-PD package?
FDA Workshop: Animal Models To Support Antibacterial Development (5 Mar 2020, post-meeting notes)
IDSA White Paper on developing narrow-spectrum antimicrobials + editorial by G. Drusano
Categories of resistance: MDR, XDR, PDR, UDR, and (new!) DTR
FDA Workshop: Animal models in support of narrow-spectrum agents for A. baumannii and P. aeruginosa
New mechanisms for antibiotic reimbursement in the United States: CMS’s IPPS FY2020 Final Rule
Plazomicin (Achaogen) financial post-mortem: #PassPASTEUR
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