R&D Insight

FDA Antimicrobial Drugs Advisory Committee (AMDAC) on 26 Apr 2019: IM Bacitracin for staphylococcal pneumonia and empyema in infants?!

Addendum: This is the first of a series of newsletters on IM bacitracin. Go here for the next newsletter. Dear All: FDA has announced that on 26 April (8:30a-1:00p) it will have an Antimicrobial Drugs Advisory Committee to “… discuss the safety and effectiveness of bacitracin for intramuscular injection for the treatment of infants with pneumonia and

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Help Alan Carr with a point survey on COVID-19 vaccines!

Dear All, Once again, we’re going to have a brief change from our usual programming with this newsletter. I hope you recognize the name Alan Carr … he is an analyst at Needham & Company (https://www.needhamco.com/) who writes regularly on the antibacterial pipeline. Go here for the most recent (14 Aug 20) newsletter on his summaries:

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In Praise of Non-Inferiority

Dear All (wonkish but intended for everybody to read and absorb): 27 Jan 2021 update: This topic now has its own YouTube video! As the ideas here are VERY confusing, I suggest you make the time to watch the video, read the newsletter, and then watch the video one more time. I have yet to

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FDA and EMA regulatory updates / Fireside chat during the 4th AMR Conference

Dear All (lots and lots of wonkish detail here, be sure your blood caffeine level is adequate!), During the 24-28 Aug 2020 BEAM Alliance-sponsored AMR Conference (go here or see below my signature for more), I had the opportunity on 27 August to chat with Sumati Nambiar (FDA) and Marco Cavaleri (EMA) about ongoing regulatory activities. The

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Final FDA LPAD guidance: Same substance, useful clarifications

Dear All, FDA have released the final version of their LPAD (Limited Population Pathway for Antibacterial and Antifungal Drugs, really should be LPPAAAD) guidance. You can get it here. I have generated a comparison with the Jul 2018 draft version that you can get here. As a reminder, the central concept of the LPPAAAD pathway

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Estimating attributable mortality of resistant bloodstream infections: GLASS (WHO) recommended method

Dear All, WHO’s GLASS Secretariat (Global Antimicrobial Resistance Surveillance System, link) have recently released a standardized method for estimating attributable mortality of antimicrobial resistant bloodstream infections. The webpage discussing the document is here; the document itself is here. GLASS currently collects surveillance data on infections in the blood as well as the urinary, gastrointestinal, and

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JPIAMR call: 25m Euro for interventions to reduce/prevent AMR

Dear All, JPIAMR is today launching an international call entitled “One Health interventions to prevent or reduce the development and transmission of AMR.” The call, with financial support from the European Commission, includes 30 funding organisations from 21 JPIAMR member countries and has a total estimated call budget of 24.9 million Euro. Here’s the description of

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