The U.S. FDA proposed in November 2023 to up-classify many wound care products that are associated with antimicrobial resistance, a change that would require a large number of clinical trials and a large volume of new premarket applications for the agency.
Vanqua Bio Inc. has divulged C5a anaphylatoxin chemotactic receptor 1 (C5aR; CD88) antagonists reported to be useful for the treatment of autoimmune disease, cancer, infections and cardiovascular, inflammatory and neurological disorders.
Basilea Pharmaceutica Ltd. has been awarded a grant from CARB-X (Combating Antibiotic-Resistant Bacteria Biopharmaceutical Accelerator) to support initial preclinical activities on the antibiotics program recently acquired from Spexis.
Gram-negative bacteria require the metalloenzyme LpxC for their outer membrane biogenesis. Blacksmith Medicines Inc. has identified an LpxC inhibitor, FG-960, which has shown a robust in vitro and in vivo profile against multidrug-resistant Enterobacterales. FG-60 is currently being investigated for the treatment of urinary tract infections (UTIs).
In a long and winding regulatory road that began with two complete response letters 15 years ago, Allschwil, Switzerland-based Basilea Pharmaceutica Ltd. finally gained U.S. FDA approval of its intravenous cephalosporin antibiotic, Zevtera (ceftobiprole medocaril sodium), to treat Staphylococcus aureus bacteremia, acute bacterial skin and skin structure infections (ABSSSI) and community-acquired bacterial pneumonia.
FmlH is a bacterial adhesin of uropathogenic E. coli (UPEC) that has been shown to be up-regulated during chronic UPEC infection. Washington University scientists recently disclosed the discovery and preclinical evaluation of novel FmlH lectin antagonists as potential candidates for the treatment of chronic urinary tract infections (UTIs) and kidney infections.
Evaxion Biotech A/S and a collaborator have successfully concluded a series of large nonrodent animal infection studies testing antigens from Evaxion’s preclinical EVX-B1 vaccine candidate against Staphylococcus aureus. The EVX-B1 antigens were shown to significantly reduce disease burden.
A group of scientists at Shanghai Virogin Biotech Co. and Zhujiang Hospital in China designed a new mRNA vaccine that could prevent tumor formation associated with human papillomavirus 16 (HPV16) and also reduce its size if used as a treatment.
Because of increasing resistance to current antimalarial drugs, new agents with novel mechanisms of action are needed. Plasmepsins are a family of 10 Plasmodium falciparum aspartic proteases (PMI to PMX), among which plasmepsins IX and X (PMIX and PMX) have been identified as potential targets due to their involvement in egress, invasion and parasite development.
The U.S. biopharma and med-tech industries are adding their voice to that of Gilead Sciences Inc. in urging the California Supreme Court to review the Gilead Tenofovir Cases, which seek to hold the drug company liable for how and when it developed its pipeline of HIV drugs.
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