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BioWorld - Tuesday, June 17, 2025
Home » Topics » Infection » Coronavirus

Coronavirus
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China remdesivir studies halted due to lack of new COVID-19 patients

April 15, 2020
By Jennifer Boggs
Two phase III studies in China testing Gilead Sciences Inc.’s antiviral drug, remdesivir, in patients with COVID-19 infection have been halted after Chinese authorities reported a lack of eligible patients. Other studies, including trials sponsored by the Foster City, Calif.-based company, remain ongoing.
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First saliva test gets EUA from FDA to detect COVID-19

April 15, 2020
By Stacy Lawrence
The collection of nasal and throat swab samples to detect the presence or absence of the novel coronavirus SARS-CoV-2 has proven problematic on a few fronts, particularly in the U.S. The swabs themselves often have become scarce and difficult to obtain, while health care workers are routinely risking their own health commonly in the absence of proper protective equipment. In addition, sampling difficulties have largely been blamed for a very high false negative rate that could be as much as 25%.
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Regulatory actions for April 15, 2020

April 15, 2020
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Algernon, Athersys, Forma, Gensight, Harbour, Humanigen, Pfenex, Remegen, Sinovac, Tetra, Urogen.
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Other news to note for April 15, 2020

April 15, 2020
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: 7 Hills, Aligos, Applied Biomath, Applied DNA, Atomwise, Axovant Gene Therapies, Bellicum, Benitec, Bold, Ensysce, Flow, Fujifilm, Gingko Bioworks, Halix, Hansoh, Histogen, Khondrion, LFB, LNC, Luxna, Mannkind, Moderna, Oakwood, Oncomyx, Promis, Pylum, Samsung, Takis, TFF, Transcelerate, Xenothera, Xylyx, Y-mabs.
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In the clinic for April 15, 2020

April 15, 2020
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Ansun, Arvinas, Cytodyn, Gensight, Ico, Mallinckrodt, Oragenics.
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Microscope image of SARS-CoV-2

Test makers, FDA struggling with shift from molecular to serology testing for SARS-CoV-2

April 14, 2020
By Mark McCarty
The age of molecular testing for the COVID-19 pandemic is still with us, but the emphasis in the months ahead will be on serological testing as a quicker, more useful mass testing alternative. However, test developers have a number of hurdles to overcome in devising these serological tests, including that antibodies for the virus’s antigens emerge at different times in the disease cycle, just one of several challenges that have to be met in the effort to bring the SARS-CoV-2 virus to heel.
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FDA grants EUAs for multiple devices that address COVID-19 cytokine storm

April 14, 2020
By Annette Boyle
Since April 10, 2020, the FDA has issued emergency use authorizations (EUAs) to several companies that make blood purification devices that can clear excess cytokines in the blood of patients with COVID-19. Monmouth Junction, N.J.-based Cytosorbents Corp.; Lakewood, Colo.-based Terumo BCT Inc.; and Marker Therapeutics AG, a subsidiary of Marker AG, of Zug, Switzerland, have all recently received EUAs for use of their products in adults with confirmed COVID-19 infections who are admitted to intensive care.
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Lungs wireframe illustration

Asclepius Meditec develops hydrogen-oxygen nebulizer to tackle COVID-19

April 14, 2020
By Elise Mak
BEIJING – Med-tech firm Shanghai Asclepius Meditec Co. Ltd. says it has developed a hydrogen-oxygen nebulizer that can help relieve the shortage of ventilators, highlighting the potential of hydrogen-oxygen therapy in tackling COVID-19. Named the AMS-H-03, this class III medical respiratory device can produce three liters of mixed gas containing hydrogen and oxygen by using water electrolysis and can run continuously for 24 hours, according to the company.
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BioWorld MedTech’s Oncology Extra for April 14, 2020

April 14, 2020
By Mark McCarty and Anette Breindl
Keeping you up to date on recent developments in oncology, including: Medical societies ink guidelines for breast cancer care for pandemic; Multiple drivers explained; Study points to new genetic associations for osteosarcoma.
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Regulatory actions for April 14, 2020

April 14, 2020
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Advanced Sterilization Products, Axonics, Becton Dickinson, Intact Vascular, The Learning Corp, Mobidiag, Spectral.
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