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.
Noze Inc. is hot on the trail of tuberculosis with its Diagnoze hand-held system that can detect the disease by its smell. The company, formerly known as Stratuscent, received additional support from the Bill & Melinda Gates Foundation to fund a study evaluating a breathalyzer designed to detect tuberculosis in high-burden countries.
The EMA’s Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending approval of Pfizer Inc.’s Emblaveo (aztreonam-avibactam), an antibiotic combination that would offer a new option to patients with serious bacterial infections caused by multidrug-resistant gram-negative bacteria.
Assembly Biosciences Inc. has disclosed bicyclic heterocycle compounds reported to be useful for the treatment of cytomegalovirus (CMV) and herpes simplex virus (HSV) infections.
While there has been progress in the development and availability of treatments and vaccines for Ebola virus (EBOV), there are still no treatments for other filoviruses such as Sudan virus (SUDV, species Sudan ebolavirus), which caused the 2022-23 outbreak in Uganda.
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