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 AMDAC – Developing Single-Pathogen agents for P. aeruginosa and A. baumannii
The 6 meanings of “Lack of Access” (UNSLAP)
How hard (and how) to Pull? Net value of Pull via a Transferrable Exclusivity Extension (TEE)
Developing systemic & inhaled antibiotics for lung infections
Plazomicin EU marketing application is withdrawn: Near zero market value of newly approved antibacterials
FDA: Early endpoints and late endpoints suggest a path to global regulatory convergence (Bart et al.)
Lancet: 10-20-30 targets to address AMR by 2030
New pipeline analysis: Cancer projects were funded 17x more than antibacterials during 2011-2020
New mechanisms for antibiotic reimbursement in the United States: CMS’s IPPS FY2020 Final Rule
Assessing antibiotic value: DTR, fire extinguishers, and a view from Australia
Melinta goes bankrupt / Never let a good crisis go to waste
Reimbursing for innovative antibiotics / Encouraging updates from the AMR conference
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