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Regulatory
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Regulatory actions for April 15, 2020

April 15, 2020
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Behold.ai, Chembio, Nova Biomedical, Ortho.
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Regulatory front for April 15, 2020

April 15, 2020
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: Advamed, Cardinal Health, Face Vital, Thermo Fisher Scientific.
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SpectrumDNA-saliva-collection-device.png

First saliva test gets EUA from FDA to detect COVID-19

April 15, 2020
By Stacy Lawrence
The collection of nasal and throat swab samples to detect the presence or absence of the novel coronavirus SARS-CoV-2 has proven problematic on a few fronts, particularly in the U.S. The swabs themselves often have become scarce and difficult to obtain, while health care workers are routinely risking their own health commonly in the absence of proper protective equipment. In addition, sampling difficulties have largely been blamed for a very high false negative rate that could be as much as 25%.
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Regulatory front for April 15, 2020

April 15, 2020
The latest global regulatory news, changes and updates affecting biopharma, including: Turing, Vyera.
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Regulatory actions for April 15, 2020

April 15, 2020
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Algernon, Athersys, Forma, Gensight, Harbour, Humanigen, Pfenex, Remegen, Sinovac, Tetra, Urogen.
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Architectural pillars

Regulatory front for April 14, 2020

April 14, 2020
The latest global regulatory news, changes and updates affecting biopharma, including: Drug Enforcement Administration, Department of Health and Human Services, FDA, International Coalition of Medicines Regulatory Authorities, EMA, European Commission, National Institute for Health and Care Excellence, NIH, Office for Human Research Protections, Pharmaceuticals and Medical Devices Agency, Therapeutic Goods Administration.
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4-14-Intact-Vascular-Tack-4F.png

FDA greenlights Tack endovascular system for below-the-knee intervention

April 14, 2020
By Meg Bryant
Wayne, Pa.-based Intact Vascular Inc. has secured U.S. FDA approval for the first peripheral vascular implant to repair below-the-knee (BTK) post-angioplasty dissections. The company expects to begin shipping units of the Tack endovascular system (4F) in about two weeks.
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Microscope image of SARS-CoV-2

Test makers, FDA struggling with shift from molecular to serology testing for SARS-CoV-2

April 14, 2020
By Mark McCarty
The age of molecular testing for the COVID-19 pandemic is still with us, but the emphasis in the months ahead will be on serological testing as a quicker, more useful mass testing alternative. However, test developers have a number of hurdles to overcome in devising these serological tests, including that antibodies for the virus’s antigens emerge at different times in the disease cycle, just one of several challenges that have to be met in the effort to bring the SARS-CoV-2 virus to heel.
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4-14-Cytosorb-Adsorber-Cytosorbents.png

FDA grants EUAs for multiple devices that address COVID-19 cytokine storm

April 14, 2020
By Annette Boyle
Since April 10, 2020, the FDA has issued emergency use authorizations (EUAs) to several companies that make blood purification devices that can clear excess cytokines in the blood of patients with COVID-19. Monmouth Junction, N.J.-based Cytosorbents Corp.; Lakewood, Colo.-based Terumo BCT Inc.; and Marker Therapeutics AG, a subsidiary of Marker AG, of Zug, Switzerland, have all recently received EUAs for use of their products in adults with confirmed COVID-19 infections who are admitted to intensive care.
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Regulatory actions for April 14, 2020

April 14, 2020
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Advanced Sterilization Products, Axonics, Becton Dickinson, Intact Vascular, The Learning Corp, Mobidiag, Spectral.
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