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BioWorld - Thursday, December 25, 2025
Home » Topics » Infection » Coronavirus

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Regulatory front for April 23, 2020

April 23, 2020
The latest global regulatory news, changes and updates affecting biopharma.
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Other news to note for April 23, 2020

April 23, 2020
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Adamis, Akshaya, Alimera, Annovis, Audax, Biovista, Cassava, Cutia, Dynavax, Epimab, Fujifilm Diosynth, Hansoh, Hemogenyx, Imquest, Insmed, Medincell, Menlo, Moleculin, Nascent, NEC, Nikang, Novelstem, Ocean, Oxgene, Prothera, Recce, Sengenics, Shenzhen Hepalink, Soleno, Takeda, Valneva.
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In the clinic for April 23, 2020

April 23, 2020
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Adocia, Aivita, Amryt, Astrazeneca, Baudax, Cel-Sci, Incyte, Leap, Obseva, Sanofi, Surface, Theravance, United Therapeutics, Windmil.
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Hand holding dollar sign

MDMA’s Leahey says lending programs give device makers short shrift

April 22, 2020
By Mark McCarty
The Main Street Lending Program (MSLP) was designed to ensure that small businesses are able to stay in business during the economic damage incurred by the COVID-19 pandemic, but Mark Leahey, president and CEO of the Medical Device Manufacturers Association (MDMA) says the program’s provisions are leaving some small device makers out in the cold, a predicament MDMA is working to resolve.
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4-22-11-health-remote-monitor.png

11 Health looks to support chronic digestive disease patients during COVID-19

April 22, 2020
By Liz Hollis
While many companies are looking to help monitor patients at home during the COVID-19 pandemic, 11 Health and Technologies Inc., of Irvine, Calif., is focused on those with chronic digestive diseases. The company recently said it was offering 12 weeks of free service using the Alfred Smartcare Platform to provide support for people with conditions such as inflammatory bowel disease, colorectal cancer and ostomies.
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Map of Latin America, South America

Med-tech companies in Argentina and Brazil ramp up ventilator production

April 22, 2020
By Sergio Held
BOGOTA, Colombia – Med-tech companies across Latin America that have traditionally focused on domestic and regional markets are in a race against time to supply ventilators to deal with worsening COVID-19 outbreaks.
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Study to evaluate benefit of Cardiologs’ AI-based tool in monitoring COVID-19 patients

April 22, 2020
By Meg Bryant
Paris-based health care startup Cardiologs Technologies SAS has launched a clinical study to assess the use of its artificial intelligence (AI) platform to remotely monitor cardiac safety in COVID-19 patients being treated with the malaria drug hydroxychloroquine. The study could help to detect and prevent serious cardiac effects of the drug.
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Antibodies fighting coronavirus

Advamed’s Van Meter says COVID-19 antigen testing ramp-up on the short horizon

April 22, 2020
By Mark McCarty
The role of diagnostic and surveillance testing in the COVID-19 pandemic is unquestionably critical, but the volume and type of tests needed to bring the economy back online is complex. Susan Van Meter, director of Advamed Dx, said on an April 22 press briefing that while molecular and serological tests will continue to play a vital role, “we’re going to see millions of antigen tests available in the coming weeks,” a development that will prove crucial in efforts to restore normal economic activity.
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Regulatory front for April 22, 2020

April 22, 2020
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: Predictive Technology Group, SC Worx, Spectrum DNA.
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Regulatory action for April 22, 2020

April 22, 2020
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Life Spine, Mobidiag, Seegene.
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