Rapid Strep A test wins FDA go-ahead:
This article was originally published in Clinica
Executive Summary
Trinity Biotech has won US marketing clearance for its rapid test for detecting streptococcus A bacteria. The Uni-Gold Strep A test, which can be performed directly on throat swabs, produces a visually-read colour change within minutes. Intended for use in hospital laboratories and point-of-care settings, the new test allows doctors to differentiate easily between bacterial and viral infections and will lead to a more appropriate and cost-effective use of antibiotics, said the Dublin, Ireland-based company.
You may also be interested in...
New EU Approvals
The Pink Sheet's list of EU centralized approvals of new active substances has been updated to add two new products, including Ryzneuta, Evive Biotechnology's treatment for chemotherapy-induced neutropenia.
Pair Of Deaths Linked To Recalled Vyaire Medical Respiratory Devices
The US FDA has labelled a recall of more than 6 million Airlife respiratory support devices class I. The recall covers devices manufactured in 2017 or earlier that can fail to provide adequate ventilation.
Over The Counter 2 Apr 2024: Analyzing The Spin-Out Trend In Consumer Health, With HBW’s Malcolm Spicer And Tom Gallen
In this episode, HBW Insight’s Europe and US editors bring their expertise to bear on the current the trend towards standalone OTC companies in global consumer health. We look at four major players: Haleon, which separated from GSK almost two years ago; Kenvue, soon to celebrate its first anniversary as a new company; Sanofi Consumer Healthcare, which is poised to split from its pharma parent; and Bayer, which has decided to buck the trend, holding on to its consumer health division. We discuss some of the advantages of becoming a standalone company, for example in leaning into a wider concept of self-care.