R&D Insight Archives • Page 20 of 35 • AMR.Solutions

FDA Antimicrobial Drugs Advisory Committee (AMDAC) on 26 Apr 2019: IM Bacitracin for staphylococcal pneumonia and empyema in infants?!

Addendum: This is the first of a series of newsletters on IM bacitracin. Go here for the next newsletter. Dear All: FDA has announced that on 26 April (8:30a-1:00p) it will have an Antimicrobial Drugs Advisory Committee to “… discuss the safety and effectiveness of bacitracin for intramuscular injection for the treatment of infants with pneumonia and

25 March 2019 No Comments

FDA Workshop: Animal Models To Support Antibacterial Development (5 Mar 2020, post-meeting notes)

Dear All (detailed and wonkish note alert … lots of thinking out loud … get some coffee and settle in!), I wrote previously (link) about FDA’s planned workshop on animal models to support antibacterial development and I was able to listen to the workshop via webcast. As brief context (and please be sure to look

8 March 2020 No Comments

What does an antibiotic cost to develop? What is it worth? How to afford it?

Dear All (long, wonkish note alert!): Today we have a 3-part discussion of cost and value with this summary 3-part message: Developing antibiotics is expensive, Not having antibiotics is even more expensive, and We have to solve this! First, what does it cost to bring a new antibiotic to market? To start us off, we

6 March 2020 No Comments

COVID-19 R&D support: US (FDA, BARDA, NIAID), Europe (EMA, EC), and globally (BioCentury resource hub)

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

16 April 2020 No Comments

Glaxo seeks buyer for two of its older antibiotics / AMR podcasts to share

Heads-up … numerous changes in the meeting calendar: Lots of new events as well as rescheduling of previously announced events. Dear All, A busy start to the week! First, I’ve received notes expressing concern regarding news that Glaxo is trying to find a buyer for (some of) its antibiotics. With all the angst about the

3 March 2020 No Comments

Global AMR Hub launches Incentives Gallery / AMR Conference is underway

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

25 August 2020 No Comments

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

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