R&D Insight

Looking forward: The global pre-clinical antibacterial pipeline / How will we care for these precious jewels?

​Dear All, Long note alert! There are two deep and deeply connected topics to share today. Refresh your coffee and settle in… Today’s first topic: Adding to the recent reviews of the clinical stage pipeline for both traditional products (link to the Sep 2019 Pew Charitable Trusts summary), and non-traditional products (link to an Aug 2019 newsletter summarizing

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Colistin is nephrotoxic / Antibiotic stewardship knowledge gaps / Fire extinguisher video

Dear All, To start your week, we have three tidbits for consideration. First, results from a trial entitled “Colistin versus meropenem in the empirical treatment of ventilator-associated pneumonia (Magic Bullet study): an investigator-driven, open-label, randomized, noninferiority controlled trial” have been published (Critical Care 23:383, 2019, link). Cisneros et al. sought to enroll 496 subjects into this trial but

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Fireside Chat with BARDA’s Branch Chief for Antimicrobials

Note: Be sure to take advantage of the BARDA Industry Day(s) event that occurs Monday-Tuesday of this coming week … see newsletter and forward calendar for details. Dear All, In what could be called Part 2 of Excellent 2023 ASM/ESCMID Talks (read the newsletter on Jen Cohen’s talk on how manufacturing underpins both access and

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PACE: A new £30m fund for AMR innovation

Dear All, Exciting additional news merits two newsletters in one day! I’ll keep it brief and quote directly from the website: “Innovate UK, LifeArc, and Medicines Discovery Catapult (MDC) have joined forces to create PACE (Pathways to Antimicrobial Clinical Efficacy), a £30 million initiative supporting early-stage innovation against antimicrobial resistance (AMR) to save lives. PACE has today (19 October 2023) announced

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EPA (part 2, streptomycin!) / $104m ARPA-H BAA and AMR project

Dear All (OK, so now it’s 5 newsletters in as many days … exciting times … can’t keep up!), Two follow-up items today. First, yesterday’s newsletter about EPA’s concept note regarding AMR risks of pesticides prompted one of your fellow readers to remind me about this lawsuit filed with the U.S. Court of Appeals, Ninth Circuit: Case

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FDA Guidance: Coordinating susceptibility (AST) device approval with drug approval

Dear All: FDA has now posted a final guidance entitled “Coordinated Development of Antimicrobial Drugs and Antimicrobial Susceptibility Test (AST) Devices” that discusses the ways that FDA seeks to: Minimize lag time between drug approval and AST device* approval and Provide recommendations on how AST developers and drug developers can coordinate their work with each other and with

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33,100 deaths in EU/EEA during 2015 attributable to resistant bacteria

Dear All: Cassini et al. have just published a truly scary paper. Here’s the bulk of the abstract … I can’t improve on it. Methods: We estimated the incidence of infections with 16 antibiotic resistance–bacterium combinations from European Antimicrobial Resistance Surveillance Network (EARS-Net) 2015 data that was country-corrected for population coverage. We multiplied the number of bloodstream

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WHO Pipeline review / Roadmap for susceptibility testing developers

Dear All: Two useful papers have just been released — see titles and abstracts below my signature. Both are Open Access so please do download & read! And just for full disclosure, know that I’m a co-author on both. First, a working group organized by WHO has produced a comprehensive review of the clinical antimicrobial pipeline for both

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Antibiotics as infrastructure / Call to Action in Ghana

Dear All: Two things today. First, Maryn McKenna has provided the community with an excellent brief perspective on the incentive problem. Entitlted “Antibiotics May Soon Become Useless. Now What?” and published in Wired, she uses the recent approval of omadacycline (Nuzyra) as a springboard to discuss the paradox of antibiotics. She quite logically extends the idea of antibiotics as fire

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