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
New pipeline analysis: Cancer projects were funded 17x more than antibacterials during 2011-2020
FDA: Early endpoints and late endpoints suggest a path to global regulatory convergence (Bart et al.)
The 6 meanings of “Lack of Access” (UNSLAP)
Lancet: 10-20-30 targets to address AMR by 2030
Two new oral drugs for gonorrhea!
Melinta goes bankrupt / Never let a good crisis go to waste
Draft EMA antibacterial guidance: Analysis
Developing antibiotics for children: There are no easy answers
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Plazomicin EU marketing application is withdrawn: Near zero market value of newly approved antibacterials
FDA Workshop: Animal Models To Support Antibacterial Development (5 Mar 2020, post-meeting notes)
FDA and EMA regulatory updates / Fireside chat during the 4th 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