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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.
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.
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Anabios, Anticancer, Aytu, Century, Correvio, Curadigm, Cytovance, Emergent, GT, Hong Kong Teson, Immunitybio, Innovation, Kuur, Medicinova, Mesoblast, Nkarta, Novavax, Point, Scintomics, Trianni.
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
With Friday’s last-minute decision to move to an all-virtual format, the opening session of the 2020 Conference on Retroviruses and Opportunistic Infections (CROI) was certainly an unusual one. “We are in uncharted waters,” conference co-chair Sharon Hillier, Richard Sweet Professor of Reproductive Infectious Disease at the University of Pittsburgh School of Medicine, told the audience via livestream.
The financial markets were delivered a one-two punch March 9 – a plunge in oil prices along with fears that the coronavirus is continuing to spread unabated. As a result, the Dow Jones Industrial Average cratered 1,500 points in early trading after a brief halt with market circuit breakers kicking in. Biopharma equities did not escape the carnage, with the BioWorld Biopharmaceutical index trading down about 4% by market close, with the Dow closing down 7.8%.
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.
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