Dear All, And now for a change from our usually scheduled content! As you might expect, major agencies in the US (FDA, BARDA, NIAID) and Europe (EMA, EC, national agencies) are actively supporting the global R&D response to COVID-19. In addition, global consortia are appearing and BioCentury has provided both a newsletter on this as well
Dear All, In case you missed it, the 4th AMR Conference sponsored by BEAM, CARB-X, Novo REPAIR, Wellcome Trust, the UK, and many others (link) is in full swing through Friday 28 Aug. The webinar technology is working well, the content is excellent, I’m seeing several hundred participants in the sessions, and chat rooms are
Dear All: Two new events on the near-term horizon. First, FDA has announced an Antimicrobial Drugs Advisory Committee for 11 Jan 2018 (and materials from the meeting can now be found here). Per the FR notice, this AMDAC will cover Aradigm’s inhaled ciprofloxacin for non-CF bronchiectasis and is almost certainly a discussion of the results Aradigm’s ORBIT-3
Dear All, WHO’s GLASS Secretariat (Global Antimicrobial Resistance Surveillance System, link) have recently released a standardized method for estimating attributable mortality of antimicrobial resistant bloodstream infections. The webpage discussing the document is here; the document itself is here. GLASS currently collects surveillance data on infections in the blood as well as the urinary, gastrointestinal, and
(Updated on 8 July 2020) Dear All, Mark your calendars now for a major global AMR initiative that will be announced by live virtual events (webinars) from Washington and Berlin on 9 July and from Tokyo on 10 July. You’ll have to wait for the day to get the full details, but the initiative will
Dear All (wonkish alert … the first 3 segments are non-wonkish but the last 2 are in the wonkish zone … titrate your plasma caffeine level appropriately), Part 1: FDA has recently released a draft guidance entitled Development of Anti-Infective Drug Products for the Pediatric Population (link). This timely guidance builds on related guidance documents
Dear All, Sharpen your pencils! The Novo REPAIR Impact Fund has just opened its 2020 call for proposals. The focus is on: Pathogens: from the high-priority list of the World Health Organization and the United States Centers for Disease Control and Prevention Therapies: first-in-class therapies have priority Modalities: small molecules, biologics and new modalities Phases: from the
Dear All: Three brief items for you today. First up: Perhaps like many of you, I’ve been wondering whether or not COVID-19 and bacterial resistance would begin to cross paths in some fashion. I can’t think of a reason why COVID-19 would directly cause resistance, but use of antibiotics becomes pretty common after you’ve been
Dear All (long-ish, wonk-ish note alert … lots of details to absorb): This newsletter has a followup here. Sadly, Melinta Therapeutics, Inc. declared bankruptcy just before the end of 2019 (link). Formerly known as Rib-X (link), Melinta went public in 2017 through a reverse merger with Cempra (link); and via a series of deals had four
Dear All: Just released is a substantial report commissioned by Wellcome Trust entitled “Vaccines to tackle drug-resistant infections: An evaluation of R&D opportunities.” The full .pdf is here. The associated website is worth exploring. In particular, there is an interactive tool that allows you to explore the parameters used to calculate relative priorities. As you probably already know, vaccines are an important