R&D Insight Archives • Page 28 of 34 • AMR.Solutions

FORWARD Act For Antifungals, NTAP Achaogen And Melinta, Novo REPAIR Funding Round

Dear All: I hope your summer is going well! Below, three items of interest. See as well several updates to the future meetings list. First,Rep. McCarthy recently introduced the FORWARD (Finding Orphan-disease Remedies with Antifungal Research & Development) Act to the United States House. Seeking to support “endemic orphan fungal disease research, incentivize Valley Fever vaccine development, discover

12 August 2018 No Comments

Listen & learn: A pair of FDA Advisory committees and a webinar on PK-PD

Dear All: New things continue to appear at a furious pace! Here are 3 excellent opportunities to listen and learn. Even if you can’t be there in person, the first is a webinar and the other two are (in my experience) very likely to be webcast: On 26 June, there will be a webinar sponsored

20 June 2018 No Comments

Concept papers for comment: EMA Antibacterial Guidance + IACG global action action

Dear All: Also appearing today are two valuable opportunities to comment on key global strategy documents. I do hope each of you can make time to look at these materials and consider sending in your thoughts — it really does make a difference when central leadership groups hear from a broad array of stakeholders! First, EMA has

19 June 2018 No Comments

21-22 Aug 2018 FDA workshop: Development of Non-Traditional Therapies for Bacterial Infections

Dear All: Following hard on the heels of yesterday’s note about the 14 June 2018 Duke-Margolis workshop on development of non-traditional products, we now have a notice regarding a 21-22 Aug FDA workshop on that same topic! The meeting will be on FDA’s White Oak Campus from 8.30a-4.30p (21 Aug) and 8.30a-noon (22 Aug). From the notice: “The purpose

19 June 2018 No Comments

The UK commits to a delinked antibiotic purchase model!

Dear All: Wow! It’s happened! As reported this morning in The Times and The Guardian among others, the UK will announce at Davos that it is committing to a 20-year vision and initial 5-year plan to combat AMR. The plan includes actions to reduce infection rates, to reduce antibiotic use, and most importantly for this audience to find a path to delinked

24 January 2019 No Comments

Calling all developers: Join the global and EU-based alliances for AMR

Dear All: Yes, I know that yesterday’s Scary/Scarier/Scariest newsletter about Achaogen was a downer. That note was as hard to write as I’m sure it was to read! I’ve received multiple comments and questions regarding the path forward and you can expect a follow-up note on this in the near future. For today, an initial way to act for

23 April 2019 No Comments

Mandatory reading: Alan Carr’s in-depth review of the antibiotic landscape

Dear All: Alan Carr (acarr@needhamco.com, Needham & Company, LLC) writes a superb investment-focused newsletter focused on the antibiotic sector. We all owe him a debt of thanks for his careful analyses. His most recent newsletter (link) is a soups-to-nuts tour that is required reading if you are working in this sector — he covers company status, development program

30 March 2019 No Comments

FDA Workshop: Leveraging Randomized Clinical Trials to Generate Real-World Evidence for Regulatory Purposes

Dear All: The idea of using real-world evidence (RWE) as a way to support development of novel agents (including antibiotics!) has always intrigued. As you may recall, the 21st Century Cures Act (Cures Act) gave FDA a mandate to evaluate the potential use of RWE to support drug approval. There was a workshop on this on

10 June 2019 No Comments

ASM-ESCMID (3-6 Sep 2019, Boston): Post-meeting notes and annotated presentations

Dear All, Apologies for the delay, but I’ve held off on this note until the majority of the presentations from the 3-6 Sep 2019 ASM-ESCMID meeting (Boston) were online. You can now access the program, most of the presentations, and the meeting abstracts here. It was a wonderful meeting with over 400 attendees. And, please be sure

28 September 2019 No Comments

Clostridioides difficile / CARB-X Year 3 Annual Report / White House OSTP seeks input on the US Bioeconomy

Dear All, Committing serial email this afternoon… First, the note I just sent on FMT for Clostridium difficile (link) prompted comments that the organism is now called Clostridioides difficile. This name change slipped past me, I’ll admit! But it does seem a settled change … see this helpful editorial from May 2019 in Lancet ID for a summary of how the new

11 September 2019 No Comments

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