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BioWorld - Tuesday, December 23, 2025
Home » Topics » Infection » Coronavirus

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Regulatory actions for May 15, 2020

May 15, 2020
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Algernon, Blueprint, BMS, Can-Fite, Clovis, Deciphera, Kancera, Leading Biosciences, Neuraptive, Seelos.
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Other news to note for May 15, 2020

May 15, 2020
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Atara, Avacta, Bioinvent, Codiak, Daiichi Sankyo, Editas, Essa, Exvastat, Halozyme, Hifibio, Iksuda, Immunitybio, Immunovative, Kleo, Lava, Legochem, Mirror Biologics, Nantkwest, NEC, Nimbus, Omass, Rapt, Roche, Rubius, Silverback, Sorrento, Syntekabio, TG, Theratechnologies, Transgene, Tyme, Vividion, VSY, Xencor.
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Richard Bright testifying before House subcommittee

Bright warns of ‘darkest winter in modern history’

May 14, 2020
By Mari Serebrov
“Our window of opportunity is closing. If we fail to develop a national coordinated response, based in science, I fear the pandemic will get far worse and be prolonged, causing unprecedented illness and fatalities,” Rick Bright, former director of the Biomedical Advanced Research and Development Authority, said today as he testified at a House subcommittee hearing on the U.S. response to COVID-19.
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Patent gears

PTO offers priority for pandemic-related patents, but time of the essence

May 14, 2020
By Mark McCarty
The U.S. Patent and Trademark Office (PTO) has opened a priority track for patents related to the COVID-19 pandemic, another signal of federal government intent on overcoming this new plague. However, Scott Marty, a partner with the Atlanta office of Ballard Spahr LLP, told BioWorld that while the program offers some distinct advantages for pandemic-driven patents, inventors should have their filings in good form before entry because any delays incurred by a less-than-airtight application could lead the PTO to boot the application out of this program.
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Dermtech collection kit components

Dermtech sees promising growth prospects despite COVID-19

May 14, 2020
By Liz Hollis
Dermtech Inc., of La Jolla, Calif., has had a busy couple of weeks, revealing late last month that its noninvasive melanoma detection test is available for use via telemedicine. Now, the company has unveiled first-quarter results that saw assay revenue of $0.8 million, a 238% increase from the first quarter of 2019.
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Microscope image of SARS-CoV-2

Mologic collaborating with Biosure to develop COVID-19 antibody self-test

May 14, 2020
By Nuala Moran
LONDON – Lateral flow diagnostics specialist Mologic Ltd. has teamed up with Biosure Ltd., manufacturer of the only CE approved HIV home testing kit, to produce a COVID-19 antibody self-test. The companies are combining Mologic’s validated IgG antibody lateral flow strip with Biosure’s test kit, and say the product will be ready for mass production at the beginning of June.
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Japanese shield and coronavirus

Japan approves first antigen test kit for COVID-19, made by Fujirebio

May 14, 2020
By David Ho and Gina Lee
HONG KONG – Japan’s Ministry of Health, Labour and Welfare (MHLW) has given the green light to Tokyo-based Fujirebio Inc.’s antigen test kit. Fumihito Takanashi, a spokesperson from the medical device evaluation division of the MHLW, told BioWorld that the approval came into effect May 14.
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Regulatory front for May 14, 2020

May 14, 2020
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: Wilmington Island Medical.
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Regulatory actions for May 14, 2020

May 14, 2020
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Applied DNA, Medalliance.
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Other news to note for May 14, 2020

May 14, 2020
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Archerdx, Bayer, Bluecross Blueshield of Tennessee, Caredx, Duality Technologies, Ekf Diagnostics, Integrated Computer Solutions, Lenovo, Lexent Bio, Progressive Care, Respiraworks, Senseonics, Transenterix, Tosoh Europe, Veracyte.
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