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BioWorld - Tuesday, June 6, 2023
Home » Topics » Infection » Coronavirus

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Regulatory front for April 8, 2020

April 8, 2020
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The latest global regulatory news, changes and updates affecting biopharma, including: Bausch Health, Mylan, Valeant.
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Coronavirus vs U.S. wrecking balls

Device makers must tread carefully regarding regulatory, legal matters even during COVID-19

April 7, 2020
By Mark McCarty
No Comments
The U.S. FDA has granted several emergency use authorizations (EUAs) to address the COVID-19 pandemic, a series of actions designed to lower regulatory hurdles. Despite these developments, the agency is keeping a close eye on issues, such as product claims, and both federal and state agencies are in a position to prosecute for hoarding and price gouging.
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Magventure-TMS.png

High-dose TMS offers depression remission in small Stanford study

April 7, 2020
By Stacy Lawrence
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To better tap into the potential of transcranial magnetic stimulation (TMS), Stanford University researchers developed a high-dose, precision-targeted protocol known as Stanford Accelerated Intelligent Neuromodulation Therapy (SAINT).
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4-7-Genetic-Signature-Easyscreen.png

Australia’s Genetic Signatures garners CE mark for its Easyscreen PCR COVID-19 diagnostic

April 7, 2020
By Tamra Sami
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PERTH, Australia – Sydney-based molecular diagnostics company Genetic Signatures Ltd. received the CE mark for its 3base Easyscreen SARS-CoV-2 detection kit, clearing the way for marketing across the EU.
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Dollar sign construction

Deerfield Management raises $840M for health care venture fund

April 7, 2020
By Meg Bryant
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New York-based Deerfield Management Co. has secured $840 million for a new venture capital fund to support innovations in biotechnology, medical technologies and digital health. James Flynn, managing partner of Deerfield, said roughly half of the fund will focus on early-stage therapeutic R&D, much of that coming from academic partnerships. The remainder will be used to back companies developing novel advances in med-tech interventions, diagnostics and digital health.
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Coronavirus, lungs

MSC-based therapies from Mesoblast, Cynata advance to tackle COVID-19 ARDS

April 7, 2020
By Tamra Sami
No Comments
PERTH, Australia – Australian stem cell therapy company Mesoblast Ltd. announced that the FDA gave it the green light to test its allogeneic mesenchymal stem cell (MSC) product candidate remestemcel-L in patients with acute respiratory distress syndrome (ARDS) caused by coronavirus (COVID-19). “We’re going to be evaluating whether an injection of our cells intravenously can tone down the immune system just enough so it gets rid of the virus but doesn’t destroy your lungs at the same time,” Mesoblast CEO Silviu Itescu told BioWorld.
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Other news to note for April 7, 2020

April 7, 2020
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Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Acumen Research Laboratories, Allurion Technologies, Almac Clinical Technologies, Artms Products, Beam Therapeutics, Bio-Rad Laboratories, Biotricity, Cure Pharmaceutical, Getinge, Imaginab, Invitae, Ivwatch, James Fisher, The Janz, Medipines, Mesa Biotech, Mirion, Nano-X, Oklahoma State University, Qure.ai, OGT, Parallax, Rapid Medical, United Global Alliance, Vortran, Xerox.
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Regulatory actions for April 7, 2020

April 7, 2020
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Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Cochlear, Genetron, Gnomegen, Motus GI, Nitiloop, Orthosensor.
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BioWorld MedTech’s Oncology Extra for April 7, 2020

April 7, 2020
By Mark McCarty and Anette Breindl
No Comments
Keeping you up to date on recent developments in oncology, including: Technetium crunch resurfaces as COVID-19 roils the globe; Microbiome changes precede tumor development in CRC; Il-27 proposed as target in prostate cancer.
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Regulatory front for April 7, 2020

April 7, 2020
No Comments
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: 3M, Boston Scientific, Gnomogen, Viracor Eurofins Clinical Diagnostics.
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