R&D Insight

BARDA’s DRIVe is looking for you! Can you help them run a venture fund?

Dear All: I’ve written before about BARDA’s DRIVe initiative (Division of Research Innovation and Ventures, launched June 2018) that seeks to develop countermeasures for chemical, biological, radiological, and nuclear threats, as well as for pandemic influenza and emerging infectious diseases.  As a core part of this work, DRIVe Ventures seeks to link innovators and investors through creation of a VC-like

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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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Updated EMA antibacterial guidance: Draft released for public consultation

Dear All: Dated 19 Dec 2018 and marked as released for public consultation on 14 Jan 2019, EMA has posted an extensively updated and consolidated version of their previously separate Guideline (CPMP/EWP/558/95 Rev.2) and Addendum (EMA/CHMP/351889/2013) documents into a single draft antibacterial guidance document. I have not yet had a chance to study in detail and will

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Categories of resistance: MDR, XDR, PDR, UDR, and (new!) DTR

Note: See also these related newsletters: 20 Feb 2020 (link) on DTR as part of the language of resistance and 7 June 2020 (link) on using DTR to estimate antibiotic value. Dear All: When thinking about studies of resistant pathogens, issues of case-finding and statistical design are frequent topics of debate. As an example, the

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Weekend reading: HABP-VABP study design; Overview of AMR initiatives

Dear All: Two papers (one with an editorial) that are worth your time. First, we have publication of the long-awaited FNIH (Foundations for the NIH) paper on trial designs for studies of HABP-VABP (Hospital-Associated Bacterial Pneumonia and Ventilator-Associated Pneumonia). The paper also comes with an editorial: Talbot, G. H., A. Das, S. Cush, A. Dane, M.

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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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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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