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BioWorld - Thursday, September 28, 2023
Home » Topics » Infection » Coronavirus

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Regulatory front for April 29, 2020

April 29, 2020
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The latest global regulatory news, changes and updates affecting biopharma.
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Other news to note for April 29, 2020

April 29, 2020
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Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Adicet, Allogene, Almac, Batavia, Beam, Catalent, Edigene, Editas, Fate, Haima, Johnson & Johnson, Heat, Innovative Cellular, Magenta, Merck, Preveceutical Medical, Proteogenix, Restorbio, Revolution Medicines, Rubius, Sanofi, Supernus, Worldmeds, Venatorx, Verndari.
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In the clinic for April 29, 2020

April 29, 2020
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Clinical updates, including trial initiations, enrollment status and data readouts and publications: Biontech, Cadent, Chimerix, Corbus, Destiny, Dynavax, Erytech, Geneone, Gilead, Gracell, Inovio, Pfizer, United Therapeutics, Windtree.
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U.S. flag and White House podium

White House proposes two antibody tests per patient in updated COVID-19 plan

April 28, 2020
By Mark McCarty
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The Trump administration has posted an update to its plan to reopen the U.S. economy, this time with a slightly different twist on testing. This plan not only calls on local governments to administer tests for the SARS-CoV-2 virus, but also calls for two antibody tests per person under some circumstances, an approach that should beef up both the positive and negative predictive values compared to a single antibody test.
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Lungpacer-DPTS-device.png

Lungpacer wins EUA for device to wean patients off ventilators

April 28, 2020
By Meg Bryant
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Reports of unusually high death rates for COVID-19 patients on ventilators have raised alarms, and some doctors are looking to reduce reliance on the breathing machines when possible. To advance that goal, Lungpacer Medical Inc., of Vancouver, British Columbia, has obtained an emergency use authorization (EUA) from the U.S. FDA for its Lungpacer diaphragmatic pacing therapy system (DPTS) for immediate use in ventilator patients at high risk of weaning failure, including patients with the novel coronavirus.
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4-28-Aytu-cedars-sinai-main-building.png

UV light, respiratory catheter for COVID-19 from Cedars-Sinai seeking emergency use

April 28, 2020
By Stacy Lawrence
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Ultraviolet (UV) light has a long-standing track record in use as an antimicrobial. But the primary limitation to using UV light in relation to the human body is that it can also potentially damage its cells. A group of researchers at the Cedars-Sinai Medical Center in Los Angeles, Calif., known as the Medically Associated Science and Technology (MAST) team, is now researching safe UV technology for use in COVID-19 treatment.
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Personal protective equipment (PPE)

New IBM network connects health care providers to alternative COVID-19 equipment suppliers

April 28, 2020
By Annette Boyle
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Armonk, N.Y.-based International Business Machines Corp. (IBM) launched the Rapid Supplier Connect network to help government agencies and health care organizations tap into new, non-traditional suppliers now producing devices and equipment needed to battle COVID-19. Membership in the blockchain-based network is free through Aug. 31, 2020, to qualified participants.
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Coronavirus punch

Cooperative research effort taking aim at genetics affecting COVID-19 infection

April 28, 2020
By Nuala Moran
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LONDON – Leading genome sequencing groups are launching the first meta-analysis in the hunt for genetic factors that explain why some people have worse COVID-19 symptoms than others, after agreeing to share patient sequence data from around the world. The COVID-19 Host Genetics Initiative (CHGI), set up by scientists at the Institute for Molecular Medicine Finland (FIMM), now includes 151 registered studies that are searching for genetic variation associated with severity and outcomes.
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Regulatory action for April 28, 2020

April 28, 2020
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Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Chronolife, Edwards Lifesciences, Exthera, Icecure, Life Spine, Lungpacer Medical, Medipines.
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Other news to note for April 28, 2020

April 28, 2020
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Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Acamp, Coala Life, Emtensor, Illumina, Invivoscribe, Labshares Newton, Meridian Bioscience, Pensees, O-Two Medical Technologies, QuantalRF, Quest Diagnostics, Seastar Medical, Seqll, Stryker, Wright Medical, Sunstar JSC, Synaptive, Wyss Institute.
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