In Brief: Cambridge Biotech urine HIV test
This article was originally published in The Gray Sheet
Executive Summary
Cambridge Biotech urine HIV test: Cambridge Biotech's HIV-1 Western Blot confirmatory test for use with urine samples is approvable. A product license application supplement can be approved upon FDA sign-off on final labeling. The kit will be offered as the confirmatory test for the Calypte HIV-1 Urine EIA screening test, which FDA approved in August 1996 ("The Gray Sheet" Aug. 12, 1996, p. 3). Under an agreement between Calypte Biomedical and Cambridge Biotech, Calypte was responsible for collecting the data to support Cambridge Biotech's PLA supplement. In June 1996, FDA's Blood Products Advisory Committee concluded the test needed more data to demonstrate its effectiveness ("The Gray Sheet" July 1, 1996, p. 12)...
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.