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
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
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
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
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.
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.
There is a follow-up to this note. Go here to read it. Dear All: I don’t like writing about doom and gloom, but a sequence of events in the past few days really drives home both the importance of the work we do to create new antibiotics as well as the fragile state of the ecosystem supporting
Dear All: FDA held a workshop (go here for workshop agenda and materials) on 8 Apr 2019 on “Development of Antibacterial Drugs for the Treatment of Nontuberculous Mycobacterial Disease.” I attended by webcast and worked with an on-the-spot attendee (David Melnick of Spero Therapeutics) to develop this summary. The workshop started with a review of the underlying
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
Duration of antibiotic dosing in veterinary medicine / Follow-up comment on FDA AMDAC on IM Bacitracin
Addendum: This is the second in a series of newsletters on IM bacitracin. Go here for the prior newsletter and here for the next newsletter. Dear All: Two somewhat overlapping ideas at the start of the week: First, FDA today announced a funding opportunity and Request for Applications (RFA) for studies that can help target and define durations