The latest global regulatory news, changes and updates affecting medical devices and technologies, including: SUNSET rule suspended; Alliance calls for speedy nomination of FDA commissioner; Pandemic costly to TB effort; FDA announces May 4 patient data meeting.
Tonix Pharmaceuticals Holding Corp. is looking to lessons from tuberculosis and smallpox to guide its future in infectious diseases. The company is developing an intradermal skin test like that used for TB to measure T-cell immunity to SARS-CoV-2, the virus that causes COVID-19. It also has three vaccines in development for COVID-19 that rely on horsepox, likely the form of vaccinia used by Edward Jenner to create the smallpox vaccine.
Researchers at the National Institute of Allergy and Infectious Diseases have shown that optimal control of tuberculosis (TB) infection necessitated immune regulation as well as immune activation – and that PD-1 checkpoint blockers exacerbated TB infections in macaque monkeys by disrupting the balance between the two.
NEW DELHI – India, which has the highest incidence of tuberculosis (TB) in the world and the second highest of COVID-19, is looking to artificial intelligence (AI) to help detect and classify cases of both and lower the cost of diagnosis.
Perkinelmer Inc. is aiming to boost its infectious disease testing footprint with the acquisition of Oxford Immunotec Global plc for $591 million in cash. The purchase, reported Thursday, will allow Perkinelmer to expand its current offerings with solutions for tuberculosis (TB) detection. Perkinelmer shares (NYSE:PKI) hit a high of $162.16 Thursday morning, before closing at $160.53 – up 2.66% from the Wednesday’s close of $156.37.
TORONTO – Within a week of completing clinical trials the chest radiography AI tool developed by Vancouver, B.C.-based 1Qbit Inc. has been given the all-clear from Health Canada for deployment across the country. The XrAI was originally developed to better identify patients with respiratory illness including SARS, pneumonia and tuberculosis (TB), but then in February was tested on a publicly available data set of COVID-19 X-ray images.
HONG KONG – Phase II data of South Korea-based Qurient Co. Ltd.’s novel antibiotic candidate may offer hope that the first universal regimen to treat tuberculosis (TB) regardless of drug resistance status has been found.
HONG KONG – Phase II data of South Korea-based Qurient Co. Ltd.’s novel antibiotic candidate may offer hope that the first universal regimen to treat tuberculosis (TB) regardless of drug resistance status has been found.
HONG KONG - South Korean biopharmaceutical company Quratis Inc. and Indonesia’s state-run company, Bio Farma PT, have entered a term sheet agreement to develop and commercialize Quratis’ tuberculosis (TB) vaccine, QTP-101, for adults and adolescents.
HONG KONG - South Korean biopharmaceutical company Quratis Inc. and Indonesia’s state-run company, Bio Farma PT, have entered a term sheet agreement to develop and commercialize Quratis’ tuberculosis (TB) vaccine, QTP-101, for adults and adolescents. The total amount of the deal is around ₩1.2 trillion (US$1.1 billion), according to the Seoul-based company.
