Category: BCG
Shots: The company has received the FDA’s CRL declining the approval of Vicineum’s BLA to treat BCG-unresponsive NMIBC The FDA has provided recommendations to conduct additional clinical/statistical data and analyses of roxadustat in addition to CMC issues related to a recent pre-approval inspection and product quality The company plans to meet with the FDA as […]
A renewed interest in whether the BCG vaccine (for tuberculosis) could also have an application for COVID-19 has been on the rise, as evidenced by this recent Cell publication, the University of Exeter’s involvement in the BRACE Trial and ongoing general press coverage. Furthermore, the list of clinical trials focusing on this area is continuing to grow (and is available here). […]
Is a century-old vaccine a ‘game-changer’ for COVID-19? Anita de Waard from Elsevier and Radoslav Kirkov from Estafet tells us how a hackathon is harnessing data science to look beyond the hype and seek definitive clinical evidence. Today, the notion of ‘data science’ has permeated almost every area of society. Words like machine learning, artificial […]
We’ve seen the scientific community come together time and again throughout the COVID-19 pandemic, and we’re thrilled to have been part of a hackathon bringing together data scientists, epidemiologists and partner organizations focusing on analysing the hypothesis of whether the tuberculosis (TB) vaccine – BCG – could reduce COVID-19 mortality. After the news hype mounted […]