Facing the global threat of antimicrobial resistance (AMR), the EMA issued a final revised guideline on the evaluation of new antibiotics. In accordance with an agreement with the U.S. FDA and Japan’s Pharmaceuticals and Medical Devices Agency, the EMA’s guideline aligns as much as possible with the data requirements of those regulators so drug developers can design clinical trials that meet the evidence needs of all three agencies, the EMA said.
Antibiotics drugs discovery, Ursula Theuretzbacher told the audience at the 2022 European Congress of Clinical Microbiology & Infectious Diseases (ECCMID), has more than one challenge to overcome.
The U.K. plan to fix the market failure in antibiotics has taken a significant step forward with the publication of guidance estimating the value of two drugs to the National Health Service.
To counter the worldwide growth of antimicrobial resistance, a subject of worldwide concern but little actual progress, Arrepath Inc. has raised a $20 million seed financing to advance its machine learning-based platform for discovering new classes of anti-infectives.
Selux Diagnostics Inc. raised $50 million in a series C financing to support the commercial launch of its next-generation phenotyping (NGP) rapid antimicrobial susceptibility testing platform. RA Capital Management LLC led the round with participation from Sands Capital, Schooner Capital and Northpond Ventures, all returning investors.
Lyme disease is the most common vector-borne disease in the U.S. and is also common in certain areas of Europe. Yet, despite this, there are no FDA-approved vaccines available to treat it, meaning those diagnosed must receive a dose of antibiotics. But antibiotics are problematic because of the risk of treatment-resistant strains emerging. That leaves a pressing need for a vaccine or other way to prevent infections from the tick-borne bacterium Borrelia burgdorferi.
A team led by researchers from the ETH Zürich and the University of Basel has used a combination of mass spectrometry data and machine learning to predict antibiotic resistance of clinical bacterial samples. The results, which were published in the Jan. 10, 2022, issue of Nature Medicine, could speed the identification of optimal antibiotic regimens for patients.
It’s been seven years since economist Jim O’Neill began his review on antimicrobial resistance, commissioned by the U.K. government to find ways to encourage development of badly needed new antibiotics. Since then, the pandemic has produced radical changes in society and forced pharma to refocus its R&D priorities at short notice. But COVID-19 has also raised awareness about the devastating effect that rogue pathogens can pose to society, and there are now serious moves to prevent a global catastrophe caused by antibiotic resistant bacteria.
An international study led by scientists at the University of Exeter in the U.K. suggests how to combine antibiotic and bacteriophage therapy optimally, in order to reduce antibiotic use and potentially prevent multidrug resistance in bacteria.
Antibiotics continue to take a beating as top-line results from Summit Therapeutics Inc.’s phase III study of ridinilazole failed to meet the primary endpoint for sustained clinical response and treating C. difficile infection (CDI). Looking for an upside on its lead candidate’s results, the company noted participants treated with ridinilazole had substantially less recurrence of CDI, the most common cause of diarrhea in hospitalized patients, as compared to those who were administered vancomycin (nominal p-value = 0.0002).
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