R&D Insight

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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12 July 2019 FDA public meeting for comments on the 2018 LPAD guidance

Dear All: Apologies for the back-to-back emails, but this one just came across the transom. In brief, FDA will hold a public meeting on Friday 12 Jul 2019 (9a-3p EDT, FDA White Oak Campus) at which FDA is soliciting public comment on the 2018 LPAD (Limited Population Pathway for Antibacterial and Antifungal Drugs) guidance. You can register

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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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Why vaccines for AMR? What is their value? Grant opportunity for research on this topic / Great NPR TED Radio Hour on vaccines

Dear All:​First, and with a closing date of 12 Sep 2019, Wellcome Trust is offering grants of up to GBP 750k for research investigating the impact of vaccines on antibiotic use and/or antimicrobial resistance (go here for details). The core goal of this funding scheme is to develop data that would support and inform vaccine decision-makers around the world as they

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Ouch! Pfizer terminates S. aureus vaccine trial due futility

Addendum: This is the third in a 3-newsletters series on this topic. Go here and here for the prior newsletters. Dear All: Per a press release today: Pfizer Inc. (NYSE:PFE) announced today that the Phase 2b trial STRIVE (STaphylococcus aureus SuRgical Inpatient Vaccine Efficacy) evaluating the company’s investigational Staphylococcus aureus (S. aureus) multi-antigen vaccine (PF-06290510) is being discontinued due to futility.

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Your vote counts! Support the UN proposal for an AMR-focused Sustainable Development Goal (SDG) Indicator

Dear All, Your vote counts! The UN’s Inter-Agency and Expert Group on Sustainable Development Goal Indicators (IAEG-SDGs) is conducting an open consultation on proposals it is considering including in the 2020 Comprehensive Review and is seeking the global community’s comments on these proposals (link to summary web page). The 17 SDGs were adopted in 2015 and are really driving

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NDM-1 in the Arctic / IACG seeks your views!

Dear All: Apologies for inundating with updates … the last few days have been very data rich! In case you missed it, McCann et al. (Env Internat, “Understanding drivers of antibiotic resistance genes in High Arctic soil ecosystems,” link) have found NDM-1, one of our more famous recent resistance genes, in the Arctic. As they state in their abstract, “The

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