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Home » COVID-19

Articles Tagged with ''COVID-19''

Flag of China and masks

Policy advocates propose measures for clinical disruptions in China

March 20, 2020
By Elise Mak and Cornelia Zou
BEIJING – China was the first country to face serious disruptions in clinical trials caused by COVID-19, and policy advocates in the country moved quickly to identify lessons for future outbreaks and address the concerns of a biotech industry in dismay.
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Other news to note for March 19, 2020

March 19, 2020
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Alibaba Cloud, Avellino Labs USA, Aytu Bioscience, Bio-Rad Laboratories, Boqi International Medical, Chongqing Guanzan Technology, Co-Diagnostics, Cosara Diagnostics, Endra Life Sciences, Medtronic, Milken Institute, Novocure, Paragon Genomics, Vitalhub, Vizient, Zorion.
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Regulatory actions for March 19, 2020

March 19, 2020
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abbott, CHF Solutions, Qiagen.
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Regulatory front for March 19, 2020

March 19, 2020
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: CME America, Mesa Biotech.
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Coronavirus and DNA

FDA greenlights emergency use of Abbott SARS-CoV-2 test

March 19, 2020
By Meg Bryant
Abbott Laboratories, of Abbott Park, Ill., is the latest company to receive emergency use authorization (EUA) from the U.S. FDA for a test to detect SARS-CoV-2, the novel coronavirus responsible for the COVID-19 pandemic. The company said it is shipping 150,000 Realtime SARS-CoV-2 tests immediately to existing customers in the U.S., with plans to produce 1 million tests a week by the end of the month.
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U.S. flag and White House podium

Defense Production Act invoked as larger volume of ventilators identified

March 19, 2020
By Mark McCarty
President Donald Trump has issued an executive order enabling the Defense Production Act, which gives the U.S. Department of Health and Human Services broader leeway to conscript industrial production to deal with the COVID-19 outbreak.
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European Union flag, coins

EU boosts funding for COVID-19 epidemic, encourages clinical trial cooperation

March 19, 2020
By Nuala Moran
LONDON – As the epicenter of the COVID-19 epidemic shifted to Europe and the number of deaths in Italy exceeded the toll in China, the EU stepped up efforts to mount a coordinated response, with a big boost for collaborative R&D funding and a call for clinical research to be pooled in multicenter, multi-arm randomized controlled trials.
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3-19-Medtronic-Puritan-Bennett-980-Ventilator.png

Major ventilator makers ramp production, even as alternatives sought to fill massive shortfall

March 19, 2020
By Stacy Lawrence
As COVID-19 testing remains elusive in the U.S., much of the nation’s focus has started to shift to how to treat the presumed millions of patients who are already or soon to be infected with the novel coronavirus.
Read More
Actemra product packaging

Genentech moves Actemra into phase III COVID-19 trial

March 19, 2020
By Cormac Sheridan
DUBLIN – The Genentech arm of Basel, Switzerland-based Roche Holding AG plans to move its interleukin-6 (IL-6) inhibitor, Actemra (tocilizumab), into a global phase III trial in patients with severe pneumonia associated with COVID-19 infection.
Read More
Thumbs down

FDA rejects de novo application for Aussie digital health company Resapp’s respiratory diagnostic

March 19, 2020
By Tamra Sami
PERTH, Australia – Australian digital health company Resapp Health Ltd. was down nearly 52% following news that the U.S. FDA rejected its de novo request for its smartphone application for the diagnosis and management of respiratory disease. The agency rejected the application, citing the need for additional information to demonstrate that the “clinical benefits of the device outweigh the risks,” CEO Tony Keating told analysts during a March 12 conference call on the news.
Read More
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