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BioWorld - Saturday, April 4, 2026
Home » Topics » Infection » Coronavirus

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Regulatory actions for Oct. 16, 2020

Oct. 16, 2020
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Becton Dickinson, Genalyte.
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Other news to note for Oct. 16, 2020

Oct. 16, 2020
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Altrix Medical, Chembio Diagnostics, Eurofins Biomnis, Jud Care, Luxfer, Myriad Genetics, Neurox, Nexgel, Stratus, Transforming Systems, Ursa Health, Vitalhub.
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Regulatory front

CMS to tweak diagnostic testing rates for COVID-19

Oct. 16, 2020
By Mark McCarty
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: FDA posts guidance agenda for FY 2021; Third-party 510(k) review report posted; NIOSH testing flunks more imported filter masks; OIG says Cedars-Sinai billed for non-compliant bariatric surgeries.
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Hospital patient wearing pulse oximeter

As WHO findings disappoint, COVID-19 developers stand in Solidarity

Oct. 16, 2020
By Randy Osborne
The large-scale failure of a handful of drugs repurposed for COVID-19 hasn’t slowed efforts to find existing – and new – therapies as well as vaccines that can fight the pandemic, with research updates continuing to roll out.
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Other news to note for Oct. 16, 2020

Oct. 16, 2020
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Abbvie, Anges, Aslan, Beyond Air, Er-kim, ICER, Macrogenics, Omeros, Takeda.
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In the clinic for Oct. 16, 2020

Oct. 16, 2020
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Adaptimmune, Amarin, Amylyx, Arch, Avalyn, Faron, Galapagos, Imara, Lipella, Pharmamar, Respira, Rocket, Y-mabs, Zynerba.
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Deal handshake with graphic overlay

Med-tech deal financials lacking in 2020; digital dominates Q3

Oct. 15, 2020
By Karen Carey
Although the volume of med-tech deals and mergers and acquisitions in 2020 rival each of the last two years, the level of disclosed values has fallen far short of 2019 in both instances.
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Other news to note for Oct. 15, 2020

Oct. 15, 2020
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Added Value Business and Marketing Solutions, Boehringer Ingelheim, Bioaffinity, Biovo Technologies, Blackstone Medical Services, Cardiac Safety Research Consortium, Fujifilm Medical Systems U.S.A., IDbyDNA , Illumina, IT-IS International, Jaya Unggul Gemilang, Konica Minolta, Mevion, Novacyt, Nupaf, Olim Het, Philips, Precision Pathology Services, Scriptsender, Smiths Medical, Summit, Trekstor, Victory Square, Volpara Solutions.
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Regulatory front

Merit Medical agrees to $18M fine in qui tam case

Oct. 15, 2020
By Mark McCarty
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: Federal Circuit declines to overturn lower court ruling for Medtronic; FDA stands pat on biotin interference threshold in final guidance; CMS adds to telehealth list.
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Human and coronavirus proteins
From mass spectrometry to massive databases

Unite and conquer approach finds shared weaknesses of coronaviruses

Oct. 15, 2020
By Anette Breindl
“It’s coming. We know it’s coming.” That was Nevan Krogan’s blunt reminder that SARS-CoV-2 is not the first virus to wreak temporary havoc on humanity, nor will it be the last.
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