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BioWorld - Wednesday, March 22, 2023
Home » Topics » Infection » Coronavirus

Coronavirus
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Vent Multiplexor’s ventilator-sharing device wins FDA nod for emergency use

April 20, 2020
By Meg Bryant
No Comments
The U.S. FDA has granted emergency use authorization (EUA) to New Haven, Conn., startup Vent Multiplexor LLC for its emergency rescue co-ventilation device. Developed in collaboration with Yale New Haven Hospital, the Vent Multiplexor enables individualized mechanical ventilation of two adults on a single ventilator – lessening demand for more critical care machines in the ongoing COVID-19 outbreak.
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Ortho Clinical Diagnostics scores win with total antibody test for COVID-19

April 20, 2020
By Liz Hollis
No Comments
The COVID-19 pandemic has moved rapidly over the past few weeks, and Ortho Clinical Diagnostics Inc. is doing its part to help during the crisis. To that end, the Raritan, N.J.-based company has worked to successfully secure an emergency use authorization (EUA) for its total antibody assay for COVID-19, the Vitros Immunodiagnostic Products Anti-SARS-CoV-2 total reagent pack and calibrators.
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Osang becomes first Korean company to win FDA emergency authorization

April 20, 2020
By Gina Lee
No Comments
HONG KONG – South Korea’s Osang Healthcare Co. Ltd. became the first Korean company to receive the U.S. FDA’s emergency use authorization (EUA) for its COVID-19 test kit. In a letter dated April 18, 2020, the FDA informed Osang of its authorization for the company’s Genefinder COVID-19 Plus Realamp Kit.
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Regulatory actions for April 20, 2020

April 20, 2020
No Comments
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Cytosorbents, Endospan, Fosun Pharma, Foundation Medicine, Genosensor, Osang Healthcare.
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Other news to note for April 20, 2020

April 20, 2020
No Comments
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: 3a-Diagnostics, Amblyotech, Assure Holdings, Avita Medical, Aytu Bioscience, Causaly, Epion Health, Medable, Median Technologies, Merit Medical, Microbac Laboratories, Midwest Products & Engineering, Mologic, Nanopass, Novabay Pharmaceuticals, Novartis, Omega Diagnostics, PDI Healthcare, Renalytix, Shenzhen Microprofit Biotech, Strata Skin Sciences, Tissue Regenix, Twist Bioscience, Ubisoft, Xphyto.
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Regulatory front for April 20, 2020

April 20, 2020
No Comments
The latest global regulatory news, changes and updates affecting medical devices and technologies.
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Investors show confidence in biopharmas developing COVID-19 therapies

April 20, 2020
By Peter Winter
No Comments
Although the COVID-19 pandemic has decimated the economy and played havoc with the financial markets, there are promising signs that investors are slowly returning as infection curves begin to flatten thanks to social distancing measures. There is no doubt that they are showing confidence in those leading biopharmaceutical companies who they believe hold the keys to unlocking cures for the deadly infection. In addition, amid the intense activity related to COVID-19 research and development, the FDA did take some time to approve several new medicines, reinforcing the fact that innovation has not been completely throttled by the industry’s focus on the pandemic.
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Novartis leaps into hydroxychloroquine fray with new phase III study

April 20, 2020
By Michael Fitzhugh
No Comments
Both ballyhooed and questioned as a potential savior from COVID-19, hydroxychloroquine is about to get a high-profile test by Basel, Switzerland-based Novartis AG. The company has reached an agreement with the FDA to run a phase III trial evaluating the drug for the treatment of hospitalized patients with COVID-19, with enrollment of 400 patients beginning within weeks and results to be reported as soon as possible.
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Future imperfect: CBER head weighs good-enough options in virus war

April 20, 2020
By Randy Osborne
No Comments
Looking ahead to COVID-19 strategies, Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research (CBER), said vaccine studies might be done not in clinics but in the streets. “By definition, we’re probably not going to be able to vaccinate everyone simultaneously,” he noted.
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U.K. pitches £500M bailout for VC-backed firms

April 20, 2020
By Nuala Moran
No Comments
LONDON – The U.K. treasury announced a £500 million (US$622.5 million) COVID-19 bailout plan for research-based startups, which could see the government holding equity stakes in venture capital-backed firms.
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