R&D Insight Archives • Page 23 of 37 • AMR.Solutions

FDA AdComm #2 on inhaled ciprofloxacin (11 Jan 2018); IMI Call for AMR diagnostics (28 Feb 2018 deadline)

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

3 December 2017 No Comments

Estimating attributable mortality of resistant bloodstream infections: GLASS (WHO) recommended method

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

20 July 2020 No Comments

SAVE THE DATE: 9 July launch of a major global AMR Initiative

(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

26 June 2020 No Comments

Draft FDA guidance on anti-infectives for children: It’s (mostly) all about PK and safety

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last 2 are in the wonkish zone … titrate your plasma caffeine level appropriately), Part 1: FDA has recently released a draft guidance entitled Development of Anti-Infective Drug Products for the Pediatric Population (link).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

7 July 2020 No Comments

Novo REPAIR Impact Fund: Global call is open through 31 July 2020

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

8 June 2020 No Comments

COVID-19 and bacterial infections / New webinars and meeting updates

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

23 April 2020 No Comments

Melinta goes bankrupt / Never let a good crisis go to waste

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

5 January 2020 No Comments

Vaccines for AMR / A major review of R&D opportunities

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

9 October 2018 No Comments

Help update the WHO clinical antibacterial pipeline analysis

Dear All: As you know, WHO produced a pipeline update with a cut-off date of 1 July 2018. It’s now published both as a manuscript (Theuretzbacher et al. Lancet ID 2018, link) and a set of summary tables (link). Team WHO would like to update this analysis with a cut-off date of 1 Aug 2019. They

6 June 2019 No Comments

WHO Pipeline review / Roadmap for susceptibility testing developers

Dear All: Two useful papers have just been released — see titles and abstracts below my signature. Both are Open Access so please do download & read! And just for full disclosure, know that I’m a co-author on both. First, a working group organized by WHO has produced a comprehensive review of the clinical antimicrobial pipeline for both

17 October 2018 No Comments

AMR.Solutions

R&D Insight