R&D Insight

Comment on US 2023-2026 National Health Security Strategy

Dear All, The US Office of the Assistant Secretary for Preparedness & Response (ASPR) is looking for comments on the 2023-2026 National Health Security Strategy (NHSS). They would like input from stakeholders in public health, healthcare, emergency management, national security, non-governmental organizations, academia, and private industry.  Their specific questions to consider are: What are the most critical national health

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EMA-FDA-PMDA action + Podcasts (CDD, Pew) + NEJM on non-inferiority

Dear All: Several updates today, all on the theme of good things to know or share! First, EMA, FDA, and PMDA are continuing to meet and have released a summary of their third tripartite meeting. The key message is alignment: alignment on trial designs for key indications, alignment on pediatric programs, and alignment on single global development programs! This is

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WAAW: Impact investing, podcasts, reports, and logos!

Dear All, Today we have a bit of a potpourri for WAAW (World Antibiotic Awareness Week). Lots of good stuff… In the new meetings category, we have two meetings for investors seeking social impact: 23 Nov 2020 (online, 6-7p CET): Webinar sponsored by Access to Medicine Foundation (ATM) entitled “The Materiality of Superbugs: Investor Action

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WHO Pipeline Review: “The world is running out of antibiotics”

Dear All:  Released just a few hours ago in parallel with the UN General Assembly meetings, WHO has produced a detailed review of the global pipeline. As they note on their overview webpage, “The report found very few potential treatment options for those antibiotic-resistant infections identified by WHO as posing the greatest threat to health, including

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Updates from EMA, FDA, and UK NICE at the 6-8 Sep 2017 ASM-ESCMID Antibiotic Development Conference

Dear All: On Wednesday 6 Sep at the ASM-ESCMID Conference on Antibacterial Development, we heard 3 superb back-to-back talks on the evolving regulatory and health technology assessment (HTA) landscape. The speakers (Marco Cavaleri, PhD, Head of Anti-Infectives and Vaccines, EMA; Sumati Nambiar, MD, Director, Division of Anti-infective Products, FDA; and Colm Leonard, MD, Consultant Clinical Adviser,

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16 Nov FDA AdComm – Inhaled ciprofloxacin for non-CF bronchiectasis

Dear All:  A Federal Register notice has been released announcing a 16 Nov 2017 FDA Antimicrobial Drugs Advisory Committee meeting to review Bayer’s inhaled ciprofloxacin for reduction of exacerbations in adults with non-cystic fibrosis bronchiectasis with respiratory bacterial pathogens (NCFB). Post-meeting addendum: Materials from the meeting can be found here. You might also want to look at materials from

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Discussing Details of ATMF’s 2021 AMR Benchmark Report!

Dear All, As you may remember, last fall I wrote a newsletter about ATMF’s 3rd update to the AMR Benchmark series. You are encouraged to read the report but in brief, the key messages are (i) the pipeline is small with most innovation coming from small biotech, (ii) stewardship and access planning are increasingly seen (but

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