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.)
Modeling the value of an effective antibiotic — Megiddo et al.
New mechanisms for antibiotic reimbursement in the United States: CMS’s IPPS FY2020 Final Rule
Draft FDA guidance on anti-infectives for children: It’s (mostly) all about PK and safety
Impact of PASTEUR: 9.9m lives saved, ROI of 125:1
The hunt for oral antibiotics: Beyond Lipinski’s Rule of Five
Melinta goes bankrupt / Never let a good crisis go to waste
Global survey of novel antibiotic reimbursement models / PASTEUR Act introduced to US House
Public meeting on the LPAD Pathway: Post-meeting thoughts (wonkish)
Assessing antibiotic value: DTR, fire extinguishers, and a view from Australia
FDA and EMA regulatory updates / Fireside chat during the 4th AMR Conference
The 6 meanings of “Lack of Access” (UNSLAP)
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