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BioWorld - Thursday, March 30, 2023
Home » Topics » Infection » Coronavirus

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Regulatory front for March 11, 2020

March 11, 2020
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The latest global regulatory news, changes and updates affecting medical devices and technologies, including: Heartware, Medtronic.
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U.S. Capitol building

Bills to ensure safety, supply of drugs and devices take first step toward passage

March 11, 2020
By Mari Serebrov
No Comments
Taking a breather from the political rhetoric that’s permeated the U.S response to COVID-19 and pushed legislation aimed at lowering drug prices to the back burner, a House subcommittee Wednesday advanced several bipartisan bills intended to improve the safety and ensure the supply of drugs and medical devices.
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Stephen Hahn, FDA commissioner

FDA’s Hahn says need to deploy test for SARS-CoV-2 across platforms delayed development

March 11, 2020
By Mark McCarty
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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.
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3-11-CHF-Aquadex.png

CHF Solutions looks to bring its tech to help COVID-19 patients

March 11, 2020
By Liz Hollis
No Comments
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.
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Lungs, COVID-19 test tube, health care worker in PPE

Australia’s Mesoblast plans to evaluate its stem cell therapy in patients infected with COVID-19

March 11, 2020
By Tamra Sami
No Comments
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.
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Other news to note for March 11, 2020

March 11, 2020
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Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Airway Therapeutics, Brii, Burke, Can-Fite, Cannabics, Coeptis, Creative Medical, Deinove, Forty Seven, Hitgen, Ideaya, Innovate, Kaken, Kamada, Medigene, Nanosmart, Nicox, Novavax, Ocumension, Oncology, Oncosec, Pascal, Phio, RDD, Rocket, Sophiris, S?rse, Tiziana, Vir.
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Coronavirus and DNA

Avellino’s coronavirus test now available, FDA approval pending

March 11, 2020
By Annette Boyle
No Comments
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.
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Postponed stamp on calendar

Preparing for COVID-19, FDA shuts down inspections, postpones meetings

March 10, 2020
By Mari Serebrov
No Comments
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.
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Regulatory front for March 10, 2020

March 10, 2020
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The latest global regulatory news, changes and updates affecting medical devices and technologies, including: Applied Biosystems, Cardinal Health, Qiagen, Roche.
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Other news to note for March 10, 2020

March 10, 2020
No Comments
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.
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