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BioWorld - Friday, July 31, 2026
Home » Topics » Infection » Coronavirus

Coronavirus
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Regulatory actions for May 14, 2020

May 14, 2020
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abivax, Aim Immunotech, Cellphire, Enzychem, Immunic, Nordic Nanovector, Pharmazz, Restem, Sanofi, Scimount, Seattle Genetics, Takeda, Verona, Zealand.
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Other news to note for May 14, 2020

May 14, 2020
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Akers, Almac Discovery, Archerdx, Astrazeneca, Bayer, Biopharmx, Biosig Technologies, Boehringer Ingelheim, Cellink, Cue, Curevac, Dtx Pharma, Histogen, Luye, Medicago, Northern Biologics, Orgenesis, Predictive Oncology, Premas, Recursion, Solid, Takeda, Timber, Uniqure, Viralclear, Yumab.
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In the clinic for May 14, 2020

May 14, 2020
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Abivax, Advaxis, Argenx, Bioxcel, Capricor, Diamedica, Frequency, Galmed, Hookipa, Horizon, Incyte, Kaleido, Krystal, LG Chem, Morphosys, Pfizer, Phoenix Tissue Repair, Regentree, Relief, Tolero, Ultragenyx, Viela, X4.
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Regulatory front for May 14, 2020

May 14, 2020
The latest global regulatory news, changes and updates affecting biopharma.
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Hand holding capsule in front of chest X-ray

Abivax to evaluate anti-inflammatory effects of ABX-464 in large-scale COVID-19 trial

May 14, 2020
By Cormac Sheridan
DUBLIN – Abivax SA has rejected an acquisition offer in order to pursue a phase IIb/III trial of its lead anti-inflammatory drug ABX-464 in 1,034 COVID-19 patients.
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Corvent Single-Use Ventilator product image

Corvent gets $4.5M to get FDA nod for shelf-stable, inexpensive, single-use ventilator

May 13, 2020
By Stacy Lawrence
Ventilators are not designed to sit in storage for long periods of time unused. But that’s precisely what’s often required of this medical device, which then may require substantial repair and updates before it is functional. That’s a tale that’s been told repeatedly in this pandemic.
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Coronavirus vs U.S. wrecking balls

FDA sees swabs as ‘hot topic,’ will hold town hall for 3D-printed swabs

May 13, 2020
By Mark McCarty
The FDA’s weekly town hall on testing for the COVID-19 pandemic included the usual range of concerns about test performance, but concerns regarding swabs and sample sites continue to mount. The predicament has led to the announcement that the FDA along with the National Institutes of Health (NIH) will hold a May 15 town hall regarding swabs, with a particular interest in swabs produced via additive manufacturing.
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Physician using an Ipad

Nanthealth looks to help cancer patients during pandemic

May 13, 2020
By Liz Hollis
How is the COVID-19 pandemic affecting cancer treatment plans? Oncologists are weighing switching treatment plans, and they have many questions. That’s where Nanthealth Inc., of El Segundo, Calif., is looking to help.
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Eko device and software in use during in-clinic screening

Eko scores EUA for algorithm to identify heart failure in COVID-19 patients

May 13, 2020
By Meg Bryant
The U.S. FDA has given the greenlight to Eko Devices Inc.’s electrocardiogram (ECG)-based algorithm to aid in detecting patients with heart failure during the COVID-19 pandemic. The artificial intelligence (AI)-powered algorithm, which provides a quick way to screen for low ejection fraction, won FDA breakthrough status in December of 2019.
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Digital illustration of U.S., coronavirus
World Medical Innovation Forum

U.S. COVID-19 Dx: Lack of centralization meets flourishing innovation, as disorder prevails

May 13, 2020
By Stacy Lawrence
The U.S. does not have a universal health care system, which means that it fails to provide a consistent level of minimum care across its population. That means that basic and preventative care often falls through the cracks, even as the U.S. continues to excel at medical innovation and offer the most highly regarded health care in the world to those who can afford it.
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