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BioWorld - Wednesday, May 31, 2023
Home » Topics » Infection » Coronavirus

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Diagram of SSO2 use for heart

Zoll's Supersaturated Oxygen Therapy receives CE mark

May 5, 2020
By Annette Boyle
No Comments
Zoll Medical Corp., of Chelmsford, Mass., received CE mark approval to market its second-generation Supersaturated Oxygen (SSO2) Therapy in Europe and other countries that accept CE mark. The therapy, which delivers hyperbaric levels of oxygen to the ischemic heart muscle immediately following percutaneous coronary intervention, has been shown to significantly reduce damage to the heart muscle after an acute myocardial infarction.
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Ethos radiotherapy system

COVID-19 leads Varian to withdraw guidance, even as overall commentary is ‘positive’

May 5, 2020
By Liz Hollis
No Comments
Palo Alto, Calif.-based Varian Medical Systems Inc. has joined the ranks of other companies in withdrawing its guidance even as at least one analyst saw positive news for the second quarter. For her part, BTIG’s Marie Thibault noted that the company missed on Americas oncology gross order metric, while falling short on consensus non-GAAP earnings per share (EPS) by five cents.
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Telehealth illustration

COVID-19 pandemic in Chile encourages a surge of telemedicine products

May 5, 2020
By Sergio Held
No Comments
BOGOTA, Colombia – As it works to more efficiently fight COVID-19, Chile is developing new regulations to support and boost telemedicine with an eye on the current outbreak but also on improving the provision of health care in the country in the long term. Patients with chronic conditions, who are at a greater risk from COVID-19, are being prioritized as the focus for telemedicine progresses.
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Respiratory infection

Roche discusses launch of newly approved serology test to detect COVID-19

May 5, 2020
By Bernard Banga
No Comments
PARIS – In the wake of the news that Swiss group Roche Holding AG received an emergency use authorization from the U.S. FDA as well as a CE-IVD certification for the Elecsys Anti-SARS-CoV-2 serology test to detect antibodies in people previously exposed to SARS-CoV-2 that causes the COVID-19 disease, the company unveiled its plans for the launch of the product.
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Coronavirus test tube, microscope, gloved hand

Shanghai’s Junshi and Eli Lilly to co-develop antibodies targeting COVID-19

May 5, 2020
By Elise Mak
No Comments
BEIJING – In one of the latest Sino-foreign collaborations formed to find a cure for the pandemic that has infected 3.5 million people worldwide, Shanghai-based Junshi Biosciences Co. Ltd. and Eli Lilly and Co. have disclosed an agreement to co-develop therapeutic antibodies for preventing and treating COVID-19. Under the terms, Junshi grants Lilly an exclusive license, outside of greater China, to conduct R&D, manufacture and distribute the SARS-CoV-2 JS-016 neutralizing antibodies developed by Junshi.
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Regulatory front for May 5, 2020

May 5, 2020
No Comments
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: Advamed.
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Regulatory actions for May 5, 2020

May 5, 2020
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Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Bio-Rad, Euroimmun, Lifesignals, Nuvasive, Vitalconnect.
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Other news to note for May 5, 2020

May 5, 2020
No Comments
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Adaptive Biotechnologies, Alung Technologies, Applied DNA Sciences, Avidium Labs, Bayer, Ben-Gurion University, Biocardia, Biocat, Caredx, Cycle Pharmaceuticals, Invicro, Labcorp, Launchpad Medical, Medherant, Microsoft, Neogenomics, Nxt Group, Oberland Capital Management, Osang Healthcare, Proteus Digital Health, Resmed, Safeguard Medical, Sg Blocks, Spartan Bioscience, Stoltz One, Tangen Biosciences, Thinklabs, Water-Jel Technologies, Zoom+Care.
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U.S. Capitol building

Rx price increases in the time of COVID stoke congressional ire

May 5, 2020
By Mari Serebrov
No Comments
While many biopharma companies are holding the line on U.S. drug prices during the COVID-19 pandemic, a few are providing more fuel to fire up lawmakers over prescription drug prices. The latest flames were stoked by last month’s 220% increase in the price of Jaguar Health Inc.’s Mytesi (crofelemer), a botanical drug used to treat the gastrointestinal side effects of HIV antiretroviral treatments. Two days after the FDA denied an emergency use authorization (EUA) for the drug to be used to treat diarrhea in COVID-19 patients who were given antivirals, Jaguar raised the price of Mytesi from $688.52 per bottle to $2,206.52 per bottle.
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Regulatory front for May 5, 2020

May 5, 2020
No Comments
The latest global regulatory news, changes and updates affecting biopharma.
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