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FR guidance is also worth reading as it provides a summary of what has been updated: “This guidance finalizes the draft guidance of the same name issued July 2, 2013 (78 FR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
Dear All: I wrote previously that EMA 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’ve now had a chance to read it in detail and thought I would share my thoughts as a way to provoke discussion. As a reminder, the
Dear All: Great stuff to read, watch, and share! First, there is an excellent new BBC documentary entitled The Truth About Antibiotics. In it, Angela Rippon provides a thorough tour at the non-scientist level of the origins of antibiotics, the devastating consequences of not having an effective choice, the role of diagnostics, and the challenges of