R&D Insight

From BARDA: 10 more years of AMR funding via an Antibacterial Accelerator!

Dear All, It’s been a busy day! Hot on the heels of today’s Duke-Margolis webinar on combatting AMR during which Senator Bennet said that he expects the PASTEUR Act to come to legislative approval this year based on strong bipartisan support (Senator Bennet is working with Senator Young), we have an announcement this afternoon that BARDA

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Open call to fund an EU-based novel antibacterial to IND

Dear All, GNA NOW (part of the IMI AMR Accelerator; this 25 Mar 2021 press release is a good overview of the AMR Accelerator) has just announced an open call to identify a novel mechanism candidate antibacterial to add to its portfolio. For those not familiar with it, the IMI AMR Accelerator is a 295 m€ IMI program

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Pull incentives in the EU / Statements by Commissioner Kyriakides

Dear All (and note the related 28 Nov 2020 newsletter), Stella Kyriakides, the European Commissioner for Health and Food Safety, made some really interesting statements before the European Parliament’s health committee (ENVI) on Thursday of last week (22 April). Per this Exchange of Views on the EP’s multimedia center and this news report, here are some

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WHO 2020 clinical/preclinical pipeline review; Chat with WHO’s Peter Beyer

Dear All, WHO have today updated their 2019 clinical/preclinical pipeline review by releasing their 2020 analyses of both the clinical and pre-clinical antibacterial product pipelines (the new 2020 report, the press release). Their 2020 review of antibacterial products in Phase 1 and beyond covers both traditional (n = 43) and non-traditional products (n = 27)

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FDA-NIAID-CDC: Developing drugs for gonorrhea, 23 Apr 21 workshop

Dear All, FDA, NIAID and CDC have announced a public workshop on development considerations of antimicrobial drugs for the treatment of gonorrhea. The workshop will cover both nonclinical (preclinical) and clinical trial design considerations: Animal models Clinical pharmacology considerations Trial design considerations for gonorrhea, such as enrollment strategies, choice of comparators and site of infection.

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Developing antibiotics for children: There are no easy answers

Aside: If you’ve enjoyed the prior discussions of movies to inspire antibiotic R&D and very apropos given the theme of today’s newsletter, please check out the newly released 4-minute YouTube discussion of a scene from Master and Commander in which antibiotics could have saved a young man’s arm! Dear All (Wonkish alert! There’s a lot of

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Vaccines to turn back the tide of antimicrobial resistance

See also This related newsletter: 14 Jul 2022, entitled “WHO Vaccine Pipeline Review; CDC On Impact Of COVID On AMR.” This 20 Oct 2024 report from WHO: “Estimating the impact of vaccines in reducing antimicrobial resistance and antibiotic use: technical report” This 25 Apr 2024 paper in Lancet Global Health by Hausdorff and colleagues: “Facilitating

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Stewardship & Access Guide from CARB-X, Wellcome, and partners: Analysis, video chat

Dear All, Novel antibacterial agents, vaccines, and diagnostics will do little if they are not widely available and used responsibly. CDDEP’s recent report entitled “The State of the World’s Antibiotics in 2021” makes this very clear: “… more people in LMICs (low-middle-income countries) die from lack of access to antimicrobials than from resistant infection.” Hence, CARB-X has

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Amended Indian PPL slide / SUPERBUGS Act / Novo REPAIR Global Call

Dear All, Three bits of news you can use… First, when I wrote yesterday about the new Indian Priority Pathogen List (PPL), I said that it was similar to the WHO PPL list except for the addition of Staphylococcus epidermidis (and speculated that this relates to the role of S. epidermidis in neonatal sepsis). Well, it

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