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U.S. FDA commissioner Stephen Hahn appeared before a congressional panel to discuss the administration’s budget proposal for the agency, but the outbreak of COVID-19 predictably dominated the proceedings.
As the COVID-19 outbreak continues to dominate the news, an increasing number of companies have come forward to help. For its part, CHF Solutions Inc., of Eden Prairie, Minn., is looking to bring its device-based intervention for fluid management to the fight.
PERTH, Australia – Australian stem cell therapy company Mesoblast Ltd. plans to evaluate its allogeneic mesenchymal stem cell (MSC) candidate, remestemcel-L, in patients with acute respiratory distress syndrome (ARDS) caused by coronavirus (COVID-19) in the U.S., Australia, China and Europe.
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
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