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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Vaccines to turn back the tide of antimicrobial resistance

Dear All, As part of their Immunization Agenda 2030: A Global Strategy to Leave No One Behind, WHO have now published an AMR-focused action framework that summarizes ways we should seek to use vaccines both to reduce antibiotic use and to prevent the further emergence of antimicrobial resistance. Here are the links you need —

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Non-traditional antibiotics: A pipeline review and an analysis of key development challenges

Dear All, Non-traditional alternatives to antibiotics have excited a lot of interest in the past few years but we’ve seen relatively few of these progress in a meaningful way (go here for Pew’s recent survey of the development landscape). Providing insights into the challenges of this area, two valuable and complementary articles on non-traditional antibiotics have recently

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FDA workshop: Clinical trial designs for agents for non-tuberculous mycobacterial infection on 8 Apr 2019

 REDear All: I just heard to today that FDA is holding a public workshop entitled “Development of Antibacterial Drugs for the Treatment of Nontuberculous Mycobacterial Disease” on 8 April 2019 from 8.30a-5.00p. Register here. Per their website, “the purpose of the public workshop is to discuss the clinical trial design considerations, including endpoints, related to the

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Mandatory reading: Alan Carr’s in-depth review of the antibiotic landscape

Dear All: Alan Carr (acarr@needhamco.com, Needham & Company, LLC) writes a superb investment-focused newsletter focused on the antibiotic sector. We all owe him a debt of thanks for his careful analyses. His most recent newsletter (link) is a soups-to-nuts tour that is required reading if you are working in this sector — he covers company status, development program

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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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Funding, Filing, and Finance: Most current update of this lecture

Dear All: I had the opportunity today to share an updated version of my “Funding, Filing, and Finance” talk with the attendees of Superbugs & Superdrugs in London. Topics covered were: Funding: What are the global initiatives? Where can you find information on how you could apply? Filing: What are the must-read background documents for developers? What

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