Iterum Therapeutics reported topline results from the SURE 3 Phase III clinical trial of an oral and intravenous penem antibiotic.
RedHill Biopharma Ltd.’s three-drug combination therapy to treat Helicobacter pylori bacterial infections was approved by the U.S. Food and Drug Administration.
GlaxoSmithKline Plc started a late-stage study testing the company’s experimental antibiotic gepotidacin in patients with urinary tract infections and gonorrhoea.
U.S. FDA Advisory Committee Recommends Approval of Cefiderocol for Treatment of Complicated Urinary Tract Infections
Antibiotics, Antimicrobial Drugs Advisory Committee, Cephalosporins, Complicated Urinary Tract Infections (cUTI), FDA, FDA/Regulatory, Gram-negative bacteria, New Drug Application (NDA), Prescription Drug User-Fee Act (PDUFA), Pyelonephritis, Recommended For ApprovalThe U.S. Food and Drug Administration’s Antimicrobial Drugs Advisory Committee voted to recommend approval of Shionogi & Co. Ltd.’s investigational antibiotic cefiderocol for the treatment of complicated urinary tract infections (cUTI), including pyelonephritis, in patients with limited or no alternative treatment options.
Shionogi Reports Positive Results from Cefiderocol Phase III Study in Adults with Pneumonia Caused by Gram-negative Pathogens
Antibiotics, Clinical Trials, EMA, European Medicines Agency, FDA, Gram-negative pathogens, Marketing Authorization Application (MAA), New Drug Applications, Nosocomial Pneumonia, R&DShionogi & Co. Ltd. announced results from APEKS-NP, an international, double-blind, randomized Phase III clinical trial evaluating the efficacy and safety of the investigational antibiotic cefiderocol in patients with nosocomial pneumonia (NP).
Bausch Health Companies Inc., together with wholly owned subsidiary Salix Pharmaceuticals Inc.’s licensor Alfasigma SpA, announced the filing of a lawsuit against Sandoz Inc. alleging patent infringement of 14 patents by the Novartis division’s submission of an Abbreviated New Drug Application for Xifaxan
(rifaximin) 550 mg tablets.
Leading scientists, public policy experts and biotech industry leaders joined forces to launch “Working to Fight AMR,” a coalition working to raise public awareness of the growing threat posed by antimicrobial resistance.
First Antibiotic With New Mechanism of Action Approved in Almost 20 Years
Antibiotics, Approvals, Community-Acquired Bacterial Pneumonia (CABP), Emergency Departments, Emergency Rooms, European Medicines Agency (EMA), Fast Track Designation, FDA, FDA/Regulatory, Priority Review, U.S. Centers for Disease Control and Prevention, Wholesale Acquisition CostThe U.S. FDA gave Nabriva Therapeutics a thumbs-up for the company’s oral and intravenous formulations of Xenleta (lefamulin) to treat community-acquired bacterial pneumonia in adults.
The U.S. Food and Drug Administration approved TB Alliance’s treatment for drug-resistant tuberculosis as part of a three-drug combination regimen called BPaL.
Scientists have found multidrug-resistant “superbug” bacteria lurking on cash machines, escalators and handrails in London’s underground rail system, shopping centers and hospitals and say they pose a potential risk to public health.
