Dear All (Wonkish alert! Get some coffee and settle in!), Almost in parallel, EMA and FDA have released updates to key antibacterial guidance documents! Here are the links you’ll need and I’ve highlighted the key documents. To go deeper, you’ll need to pick through everything and I provide a tour further below in this newsletter: EMA’s
Dear All, It doesn’t rain … it pours! Just seconds after sending out a newsletter on the 18 May et seq. Squash Superbugs Day of Action, I learned that FDA has announced a 3 June 2022 workshop on uUTI! From their webpage on the event: “The workshop will focus on nonclinical and clinical considerations regarding antimicrobial
Dear All, I just today learned that FDA have posted their FY 2023 funding opportunities. All the details are on this webpage and I’m just going to reproduce the text below my signature for your reference. I’ll also add a few details in italics. Lots of good opportunities here! –jr John H. Rex, MD |
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
Dear All, Two things today — the first on using MICs and the second on re-using MICs. Read on! On using MICs (minimum inhibitory concentrations), we have additional details on the FDA BAA discussed in my 9 Oct 2023 newsletter, In particular, I’d like to draw your attention to a time-limited request regarding a request
Addendum: This is the second in a 3-newsletters series on this topic. Go here for the first newsletter and here for the final newsletter. Finally, the results of the STRIVE trial have been published as Hassanzadeh et al. in Clinical Infectious Diseases, ciad218, https://doi.org/10.1093/cid/ciad218. Dear All: I wrote on 19 Oct 2017 about the meeting on 7 Nov 2017
Dear All: Two updates today. First, our colleagues at London School of Economics have just published a review of antibiotic innovation incentives that includes a detailed review of some of the currently available sources of funding (Simpkin VL et al., Incentivising innovation in antibiotic drug discovery and development: progress, challenges and next steps. J Antibiot, 1 Nov 2017). As
Dear All: A Federal Register notice has been released announcing a 16 Nov 2017 FDA Antimicrobial Drugs Advisory Committee meeting to review Bayer’s inhaled ciprofloxacin for reduction of exacerbations in adults with non-cystic fibrosis bronchiectasis with respiratory bacterial pathogens (NCFB). Post-meeting addendum: Materials from the meeting can be found here. You might also want to look at materials from
Dear All, I’ve watched with interest the way that FDA’s CVM (Center for Veterinary Medicine) has been working steadily with the veterinary community as a whole to reduce antibiotic resistance pressure by improving the way antibiotics are used in animal care. The titles of these prior newsletters give you a feel for some aspects of
Dear All, Two quick items today. First, FDA have announced an Antimicrobial Drugs Advisory Committee on 17 April 2023 (9a-4.30p ET). The committee will “discuss new drug application (NDA) 216974, for sulbactam-durlobactam for injection, submitted by Entasis Therapeutics, Inc. The Applicant’s proposed indication is for the treatment of infections due to Acinetobacter baumannii-calcoaceticus complex including multidrug-resistant and
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