R&D Insight

Extended deadline: NIAID call for proposals for therapeutics & vaccines for resistant bacteria

Also note several new webinars in the forward meeting list! Dear All: NIAID currently has an open BAA (Broad Agency Announcement, HHS-NIH-NIAID-BAA2019-1, link), that calls for proposals across three research areas: Medical Countermeasures (MCMs), therapeutics for resistant bacteria, and vaccines for resistant bacteria. The deadline for Research Area 001 (MCMs) is still 20 May 2019, but the

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CARB-X 2019: Calls announced covering non-traditionals, vaccines-biologics, diagnostics, and direct-acting small molecules

​Aside: There is now an application link for the Mar 2020 Antibacterial R&D GRC meeting. See calendar listing below my signature! Dear All: CARB-X this week announced its 2019 calls for proposals (link). There are four application rounds: Non-traditional approaches: Funding Round 1 will be open for Expressions of Interest June 3 – June 10, 2019, 5 PM

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Upcoming BARDA RFP to acquire antibiotic(s) for biothreat indications!

Dear All: Ready, set, (get ready to) go! I just today learned of this really important US government pre-solicitation notice (lightly reformatted excerpt follows, see here for the whole thing): “The Government seeks an FDA-approved antibiotic(s) for a biothreat indication (Y. pestis, B. anthracis, F. tularensis, B. mallei and/or B. pseudomallei) for delivery to the Office of the Assistant Secretary for Preparedness and Response

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Novo REPAIR Impact Fund is open for EU proposals: 10 May 2019 deadline

Dear All: The Novo REPAIR Impact Fund is open for its second round of EU-based proposals! Four projects have been funded to date by this $165m project. Could you be among the next?  Initial non-confidential proposals are due 10 May 2019. The broad scope is Discovery through Phase 1 for projects focused on therapeutics to address antibacterial resistance.

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6 Jun 2019 FDA AMDAC: Discussion of Pretomanid’s NDA for MDR-XDR TB

Dear All:  FDA today posted a Federal Register announcement of an Antimicrobial Drugs Advisory Committee (AMDAC) meeting on 6 June 2019. The AMDAC will discuss pretomanid (formerly, PA-824) tablets for oral administration, “proposed as part of a combination regimen with bedaquiline and linezolid in adults for the treatment of pulmonary extensively drug resistant and treatment-intolerant or non-responsive

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12 July 2019 FDA public meeting for comments on the 2018 LPAD guidance

Dear All: Apologies for the back-to-back emails, but this one just came across the transom. In brief, FDA will hold a public meeting on Friday 12 Jul 2019 (9a-3p EDT, FDA White Oak Campus) at which FDA is soliciting public comment on the 2018 LPAD (Limited Population Pathway for Antibacterial and Antifungal Drugs) guidance. You can register

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India bans food ag use of colistin / CDC updates report on US use of antibiotics

Dear All, Two mid-week notes: First (and huge!), India’s Ministry of Health issued a notification last week prohibiting the “manufacture, sale and distribution of the drug colistin and its formulations for food-producing animals, poultry, aqua farming and animal feed supplements” because such use is “likely to involve risk to human beings.” You can find this on multiple

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