Low enrollment in a phase III trial and a missed primary endpoint sent Aridis Pharmaceuticals Inc.’s shares tumbling by 35% on Jan. 26, although the company’s AR-301 (tosatoxumab) showed superior efficacy over the control group in Staphylococcus aureus ventilator-associated pneumonia (VAP) patients.
Microbiome company Finch Therapeutics Group Inc. has suffered one blow after another in the past year with dwindling cash, delayed programs, a terminated deal and three workforce reductions. The latest reduction will bring the once healthy 189-person company down to a handful of employees, and it places the lead program – the oral microbiota product, CP-101, for Clostridiumdifficile infection – on the sidelines.
Albeit with complaints and provisos, the U.S. FDA’s Antimicrobial Drugs Advisory Committee (ADAC) rubber-stamped Cidara Therapeutics Inc.’s rezafungin, an injectable treatment for candidemia and invasive candidiasis (IC) in adults. Panelists were asked to vote on a single question: “Is the overall benefit-risk assessment favorable for the use of rezafungin for treatment of candidemia/IC in adults with limited or no alternative treatment options?” The balloting turned out 14 yes, one no.
Shanghai Institute of Materia Medica of the Chinese Academy of Sciences and Wuhan Institute of Virology of the Chinese Academy of Sciences have synthesized amide compounds reported to be useful for the treatment of dengue virus infection, skin inflammation, inflammatory joint disease, inflammatory bowel disease and autoimmune disease.
Next week, Cidara Therapeutics Inc. will make its case for rezafungin, an injectable treatment for candidemia and invasive candidiasis in adults, before the U.S. FDA’s Antimicrobial Drugs Advisory Committee. When it convenes Jan. 24, the adcom will vote either yes or no if it believes the overall benefit-risk assessment is favorable for the use of rezafungin for treating candidemia/invasive candidiasis in adults with limited or no alternative treatment options.
Bacterial abortive infection is a defense mechanism by which an infected bacterial cell enters dormancy or dies to limit phage replication and protect the clonal population. Recent studies observed that CRISPR RNA-guided adaptive immune systems that target RNA also cause abortive-infection phenotypes by activating indiscriminate nucleases.
Researchers at the Barcelona Institute of Science and Technology’s Center for Genomic Regulation (CRG) and Pulmobiotics Ltd. have used one bacterium to fight another. In mouse models, the team used engineered Mycoplasma pneumoniae to treat Pseudomonas aeruginosa, the chief culprit in ventilator-associated pneumonia (VAP).
Just as the U.S. mpox public health emergency declaration is about to end, the FDA is releasing a draft guidance on developing drugs and biologics to treat infections caused by the virus.
The U.S. Department of Health and Human Services received low marks on its latest Government Accountability Office (GAO) report card for its oversight of high-risk research involving potential pandemic pathogens, but legislative fixes might be necessary to ensure that all the gaps are closed.
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