Dear All: Apologies for inundating with updates … the last few days have been very data rich! In case you missed it, McCann et al. (Env Internat, “Understanding drivers of antibiotic resistance genes in High Arctic soil ecosystems,” link) have found NDM-1, one of our more famous recent resistance genes, in the Arctic. As they state in their abstract, “The
Dear All: We had hints back in January that this was coming (see this post), but now it is really happening! In brief, UK’s NHS will test the world’s first subscription-style payment model in which payments delinked from volume are used to incentivise pharmaceutical companies to develop new drugs for resistant infections. Below my signature, I’ve
Dear All, I previously wrote (link) about the first of Jason Gale‘s 4-part podcast series on AMR. The whole series is now out and definitely worth your time. Each podcast is about 30 minutes long … please set aside a bit of time to listen to all four! Here they are: #1: In a detailed look at
Dear All: Two things of note this afternoon… First, the previously noted BARDA RFP to acquire biothreat antibiotics is now posted here with submissions accepted through 21 June 2019: “Under this RFP, BARDA plans to support the procurement of antibiotic(s), which will either be delivered to the ASPR/SNS or maintained as VMI, using Project BioShield (PBS) funds. “PBS funds will also support
Dear All: Here’s a potpourri today of several new entries in the forward meetings list below my signature. First, the US FDA will meet with CDSCO (Central Drugs Standard Control Organization, the Indian equivalent of FDA & EMA) in a workshop in Mumbai on 8 Mar. More details here! It’s great to see the global regulatory agencies continuing
Dear All, Today’s topics all share the theme of Less Talk, More Action! Here we go… First up … news from the US. I’ve written before about tweets from US CMS (Centers for Medicare and Medicare Services) administrator Seema Verma (link) on the need for changes in antibiotic reimbursement as well as the very concrete steps taken in
Dear All: Just out in the last 24h is the announcement that FDA’s 2013 Unmet Need Guidance has now been released in final form. The associated FR guidance is also worth reading as it provides a summary of what has been updated: “This guidance finalizes the draft guidance of the same name issued July 2, 2013 (78 FR
Dear All: As recently summarized by Pew Trusts’ reviews of the antimicrobial pipeline, there is a lot of interest in non-traditional (alternative) antimicrobial agents but there has also been a lot of concern that they are harder to develop than more traditional agents. If you’ll permit me to (briefly) coin the term Fleming Antibiotic to describe things like penicillin,
Dear All: Two things today. First, Maryn McKenna has provided the community with an excellent brief perspective on the incentive problem. Entitlted “Antibiotics May Soon Become Useless. Now What?” and published in Wired, she uses the recent approval of omadacycline (Nuzyra) as a springboard to discuss the paradox of antibiotics. She quite logically extends the idea of antibiotics as fire
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