Avellino Lab USA Inc. has developed a diagnostic test for the novel coronavirus SARS-CoV-2, which has been validated in keeping with the U.S. Food and Drug Administration (FDA)'s Policy for Diagnostics Testing in Laboratories Certified to Perform High-Complexity Testing under CLIA prior to Emergency Use Authorization for Coronavirus Disease-2019 during the Public Health Emergency. Physicians can order the assay now, while the company continues testing.
HONG KONG - India has made amendments to the export policy of certain active pharmaceutical ingredients (APIs) and the formulations based on some specific APIs.
BEIJING – Beijing-based Sihuan Pharmaceutical Holdings Group Ltd. said it has initiated clinical trials of broad-spectrum antiviral favipiravir to treat COVID-19. China now has six clinical trials investigating the drug, originally developed for influenza and also tested against Ebola virus disease.
A list of biopharma companies and nonprofit entities, including academia, working feverishly to find a vaccine or antiviral treatment to address the rapidly spreading coronavirus, now known as COVID-19, has more than doubled, increasing from about 30 a few weeks ago to 71 as of March 6.
HONG KONG – U.S., China and the Netherlands-based Harbour Biomed Therapeutics Ltd. has teamed up with Mount Sinai Health System, New York City's largest academic medical system, to develop novel biotherapies in oncology and immunology. The two parties will also be using Harbour’s H2L2 Harbour Mice platform to develop a monoclonal antibody (MAb) against the coronavirus that has turned into a global epidemic.
LONDON – The Gates Foundation and Wellcome Trust have joined forces with financial services specialist Mastercard in establishing a $125 million seed fund to accelerate development of drugs to treat COVID -19.
Despite the growing concerns about the potential for the community spread of COVID-19 in the U.S., the FDA-FTC public workshop on competition in the biologics marketplace went ahead as scheduled March 9, playing to a full house with some audience members sitting in an overflow room. And all the invited speakers and people registered to speak during the open public hearing session showed up.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: Applied Biosystems, Cardinal Health, Qiagen, Roche.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Assure Holdings, BD, Certest Biotec, Change Healthcare, Clearwave, Curetis, Imprivata, Masimo, Mckesson, Microsoft, National Comprehensive Cancer Network, Nemaura Medical, Opgen, Prevencio, Unlimited Systems.
LONDON – The Gates Foundation and Wellcome Trust have joined forces with financial services specialist Mastercard in establishing a $125 million seed fund to accelerate development of drugs to treat COVID -19. The COVID-19 Therapeutics Accelerator aims to play a catalytic role by speeding up evaluation of new and repurposed drugs and biologics to treat the novel coronavirus in the near term, and other viral pathogens in the longer term
