Govt Approves 1st Use Of Regenerative Medicine In Japan (Japan)
This article was originally published in PharmAsia News
Executive Summary
The Japanese government has given approval to Bioventure Japan Tissue Engineering Co. (J-TEC) to manufacture and sell skin for use in treating serious burns, the first such approval for the use of regenerative medicine in Japan. Skin cells that have been cultured for approximately two weeks are used in the treatment, with technology enabling a 1-sq.-cm sample to grow up to 1,000 times larger. The new skin, once grown, is applied to the damaged part of the body, significantly reducing the chances of rejection compared with procedures using another person's skin. J-TEC also plans to seek approval from the Health Ministry for regenerative treatments to restore the functions of knee cartilage and the epithelium of the cornea. (Click here for more - May Require Paid Subscription
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.