Morning Briefing
Summaries of health policy coverage from major news organizations
New IV Antibiotic Combo For cUTI Being Reviewed; Benefits Of New Cancer Meds Unclear
CIDRAP: FDA OKs Priority Review For Antibiotic Combo For Complicated UTIs
Venatorx Pharmaceuticals, based in Malvern, Pennsylvania, today announced that the US Food and Drug Administration (FDA) has accepted for priority review its cefepime-taniborbactam antibiotic combination for treating complicated urinary tract infections (cUTIs). Cefepime-taniborbactam is an investigational intravenous (IV) beta-lactam/beta-lacatamase inhibitor antibiotic developed for adults with cUTI, including pyelonephritis. The drug has previously received FDA fast-track designation, and the FDA has set a target action date of February 22, 2024. (Schnirring, 8/15)
ScienceDaily: Many Expensive Cancer Drugs Have Unclear Patient Benefit
New cancer drugs are being launched at a rapid pace, before their long-term effectiveness for patients can be evaluated. Several years later, most of them still lack scientific evidence for actually increasing life expectancy or improving quality of life. (University of Gothenburg, 8/15)
Reuters: Revance's Botox Rival Gets FDA Approval For Painful Neck Muscle Condition
The U.S. health regulator has approved expanding the use of Revance Therapeutics' Daxxify to treat a painful neck muscle condition, intensifying the anti-wrinkle injection's rivalry with AbbVie's Botox. The approval by the Food and Drug Administration helps Revance enter the $2.5 billion U.S. market for therapeutic neuromodulator, a method that directly acts on nerves, the company said on Monday. (Leo, 8/14)
ScienceDaily: Synthetic Antibiotic Could Be Effective Against Drug-Resistant Superbugs
A scientific journey decades in the making has found a new antibiotic strategy to defeat gram-negative bacteria like Salmonella, Pseudomonas and E. coli, the culprits in many urinary tract infections. (Duke University, 8/9)
