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BioWorld - Monday, December 29, 2025
Home » Topics » Infection » Coronavirus

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Regulatory front for June 18, 2020

June 18, 2020
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: Antibodiescheck.com, Medakit, Sonrisa Family Dental.
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Regulatory actions for June 18, 2020

June 18, 2020
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Aethlon, Icotec, Naviswiss, Pear Therapeutics, Sirakoss.
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Other news to note for June 18, 2020

June 18, 2020
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Aduro, Align Technology, American Telemedicine Association, Aramark, Archerdx, Bristol-Myers Squibb, China Medical Holdings, Foxconn, Gelesis, Gingko Bioworks, Harvey Nash, Inivata, Medstar Health, Medtech Innovator, Medtronic, Monitorme, Natera, Nephros, One Medical, Philips, Quest Global, Usgi.
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BioWorld MedTech’s Diagnostics Extra for June 18, 2020

June 18, 2020
By Meg Bryant and Anette Breindl
Keeping you up to date on recent developments in diagnostics, including: Improving diagnosis of pulmonary hypertension; A web-based COVID-19 assessment tool; Discovering pharmacological enzyme activators.
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Empty waiting room

Poised for second round, pandemic creates backlog of untreated diseases

June 18, 2020
By Mari Serebrov
Countries and health care providers should hope for the best but prepare for the worst as a resurgence of COVID-19 is expected in the fall, just as the influenza season hits.
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Other news to note for June 18, 2020

June 18, 2020
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Archerdx, Atyr, Avacta, Bavarian Nordic, Bridgebio, BMS, Calypso, Codagenix, Emergent Biosolutions, Gelesis, GNS Healthcare, Lyell, Mind Medicine, Ocuphire, Pact Pharma, Rexahn, Sarepta, Selecta, Sumitomo, Sunovion, Synairgen, Tonix, Urovant, Valneva.
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Other news to note for June 17, 2020

June 18, 2020
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: 4D Molecular, Amarin, Apotex, Armata, Berg, BMS, Cellics, Clearside, Cyclo, Farmacore, Innovation, ISA, Kamada, Lantheus, Nascent Biotech, NTC Srl, PDS, Precision Nanosystems, Progenics, Sirnaomics, Staidson, Taro, Teva, Transcelerate, Ubiquigent.
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Telehealth illustration

Senate HELP Committee considers telehealth after pandemic

June 17, 2020
By Meg Bryant
The COVID-19 pandemic has fueled an unprecedented uptick in telehealth use, from medical and behavioral health services to remote patient monitoring, as federal and state regulators have relaxed certain policy restrictions to increase access to care. Sen. Lamar Alexander (R-Tenn.) recommended in a Senate hearing that certain temporary policy changes, such as elimination of the “originating site” rule and expansion of Medicare- and Medicaid-covered telehealth services, should be lasting to ensure patients retain health care access when the crisis is over.
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U.S. FDA headquarters

FDA lays out top priorities for COVID-19 testing, weighs in on asymptomatic screening

June 17, 2020
By Stacy Lawrence
The U.S. FDA detailed which kinds of SARS-CoV-2 tests are getting top priority, with access to rolling, rapid reviews for emergency use authorization (EUA) during the unfolding pandemic. The agency is aiming to authorize point-of-care and at-home tests to better distribute the use of testing in various locations. It also is looking at automated and high-throughput tests that can offer analysis of larger batches of tests at one time.
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Resistanceplus product packaging

Australia’s Speedx partners with Roche to expand access to qPCR antibiotic resistance tests

June 17, 2020
By Tamra Sami
PERTH, Australia – Sydney-based Speedx Pty. Ltd. has signed a global distribution deal with Roche Holding AG, through which the latter will sell Speedx’s Resistanceplus MG and Resistanceplus GC molecular tests for detecting antimicrobial resistance to Mycoplasma genitalium (Mgen) and gonorrhea, respectively.
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