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BioWorld - Sunday, May 18, 2025
Home » Topics » Infection » Coronavirus

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Regulatory front for June 5, 2020

June 5, 2020
The latest global regulatory news, changes and updates affecting medical devices and technologies.
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Regulatory actions for June 5, 2020

June 5, 2020
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abiomed, Medtronic, Opti Medical Systems.
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Hydroxychloroquine prescription bottle
‘Unequivocal evidence’

Study shows no clinical benefit with hydroxychloroquine in hospitalized COVID-19 patients

June 5, 2020
By Nuala Moran
LONDON – After all the controversy and a huge dose of hype, there is no clinical benefit from the use of hydroxychloroquine in patients admitted to the hospital with COVID-19, according to headline data from a large randomized trial of potential drugs for the infection currently running in the U.K.
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Vaccine administration

Gavi sets up advance market commitment program for COVID-19 vaccines

June 5, 2020
By Nuala Moran
LONDON – The foundation stone of a system to ensure equitable access to COVID-19 vaccines was put in place by the global vaccines summit on June 4, with 12 donors pledging $567 million in seed money for an advance market commitment (AMC) program.
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Other news to note for June 5, 2020

June 5, 2020
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Abbvie, Aeterna Zentaris, Astrazeneca, Avita Medical, CSL, Engage, Harbour, Healios, Kalytera, Liquidia, Magenta, Novavax, Ryvu, Sorrento, UCB, United Therapeutics.
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Regulatory front for June 4, 2020

June 4, 2020
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: Palmetto GBA, Procept Biorobotics.
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Regulatory actions for June 4, 2020

June 4, 2020
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Bausch + Lomb, Roche, Synedgen, Transit Scientific.
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Other news to note for June 4, 2020

June 4, 2020
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Ace Surgical Supply, Discoverybiomed, Envisiontec, Facedrive, Fullerton Health, Med-El, Meditouch, Microbix Biosystems, Mölab, Mybio, Myolyn, Open Orphan, Rakuten Medical, R-Biopharm, University of Texas MD Anderson Cancer Center, Vapotherm, Zebra Technologies.
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Glass vial production line

Supply shortages continue to threaten pandemic response

June 4, 2020
By Mari Serebrov
During a massive disaster or a pandemic, securing the necessary manufacturing capacity, needles, syringes, vials, properly labeled caps, reagents and other supplies is as critical as the development of the product itself. Some experts have been warning about these needs since COVID-19 first began spreading outside of China. Now members of Congress are sounding the alarm.
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Lungs

Dimerix’s lead candidate to enter global REMAP-CAP trial to treat COVID-19 ARDS

June 4, 2020
By Tamra Sami
PERTH, Australia – Melbourne, Australia-based Dimerix Ltd. saw its shares gain 66% on the news that its lead candidate, DMX-200, has been chosen to enter the global REMAP-CAP platform trial as a potential treatment  for COVID-19-related acute respiratory distress syndrome (ARDS).
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