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BioWorld - Wednesday, February 8, 2023
Home » Topics » Infection » Coronavirus

Coronavirus
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Two South Korean COVID-19 kits look overseas, seek FDA approval

March 24, 2020
By Gina Lee
No Comments
HONG KONG – As the number of COVID-19 confirmed cases and deaths continue to rise globally, South Korea’s focus on testing has attracted international attention. Two diagnostic kits made by domestic companies Seegene Inc.and Kogene Biotech Co. Ltd. are currently preparing to apply for U.S FDA approval.
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3-23-Senseonics-Eversense-CGM-System.png

Senseonics feels the liquidity squeeze, as lender forces it to seek out strategic alternatives

March 24, 2020
By Stacy Lawrence
No Comments
Trying to build out a new med-tech product category is a time-consuming and costly endeavor. Senseonics Holdings Inc. has long pursued the vision of extended-use, implantable continuous glucose monitoring. Since it was founded in 1996, the Germantown, Md.-based company has already spent roughly half a billion dollars to get there.
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3-24-Everlywell-COVID-19-kit.png

Everlywell restricts at home testing to health care professionals

March 24, 2020
By Annette Boyle
No Comments
Everlywell Inc. stepped back from its announcement that consumers could access at-home testing for COVID-19 starting on March 23, 2020, following a U.S. FDA update that cautioned against fraudulent at-home tests.
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Man using Gammacore device on neck

Electrocore sees net sales rise 141% over previous year but suspends guidance over COVID-19

March 24, 2020
By Liz Hollis
No Comments
Despite seeing good growth in 2019, with net sales jumping to almost $2.4 million vs. $993,000 over the previous year, Electrocore Inc. has suspended its guidance due to uncertainty over COVID-19. The company previously said full-year revenue should be in the range of $7 million to $9 million.
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Coronavirus vs U.S. wrecking balls

Legislators press White House to activate DPA to combat COVID-19

March 24, 2020
By Mark McCarty
No Comments
The pressure is rising on the Trump administration to activate the Defense Production Act (DPA) for the COVID-19 outbreak as the Senate yet again reconsiders an economic stimulus package. Sens. Brian Schatz (D-Hawaii) and Chris Murphy (D-Conn.) unveiled the Medical Supply Chain Emergency Act in an effort to force the White House to mandate the production of needed supplies, a bill that is likely to languish until Congress can move on economic relief legislation.
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Telehealth illustration

Clinical testing and the new virtual reality in time of COVID-19

March 24, 2020
By Lee Landenberger
No Comments
It took less than a week from the publication of Science 37’s whitepaper on March 12 encouraging virtual clinical trials to the FDA’s decision to endorse the idea, tailored to address the COVID-19 pandemic.
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Australia and coronavirus

As Australia shuts its borders, the country looks within to manage COVID-19 pandemic

March 24, 2020
By Tamra Sami
No Comments
PERTH, Australia – As Australia closes its borders to all non-citizens and non-residents, it looks within the country for solutions to manage the worsening COVID-19 pandemic.
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Regulatory front for March 24, 2020

March 24, 2020
No Comments
The latest global regulatory news, changes and updates affecting biopharma.
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Regulatory actions for March 24, 2020

March 24, 2020
No Comments
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Chipscreen, Gilead, Inmed, Prevail, Samsung Bioepis.
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Other news to note for March 24, 2020

March 24, 2020
No Comments
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Ability, Acura, Akers, Aldeyra, Algernon, Ampio, Atyr, Axim, Bioinvent, Cystron, Inovio, Ivix, Lonza, Mabpharm, Ology, Ovoca, Pieris, Point, Protokinetix, Resverlogix, Roche, Santhera, Skylindex, Sorrento, Servier, Triumvira, Valneva, Vero, Windtree.
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