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BioWorld - Sunday, February 5, 2023
Home » Topics » Regulatory

Regulatory
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Lungpacer-DPTS-device.png

Lungpacer wins EUA for device to wean patients off ventilators

April 28, 2020
By Meg Bryant
No Comments
Reports of unusually high death rates for COVID-19 patients on ventilators have raised alarms, and some doctors are looking to reduce reliance on the breathing machines when possible. To advance that goal, Lungpacer Medical Inc., of Vancouver, British Columbia, has obtained an emergency use authorization (EUA) from the U.S. FDA for its Lungpacer diaphragmatic pacing therapy system (DPTS) for immediate use in ventilator patients at high risk of weaning failure, including patients with the novel coronavirus.
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Regulatory front for April 28, 2020

April 28, 2020
No Comments
The latest global regulatory news, changes and updates affecting biopharma, including: Biomedical Advanced Research and Development Authority, COVID-19 EMA Pandemic Task Force, Cybersecurity and Infrastructure Security Agency, EMA, European Commission, FDA, Heads of Medicines Agencies, National Institute for Health and Care Excellence, NIH, Therapeutic Goods Administration, U.S. Cyber Command, U.S. House and Senate, Wuhan Institute of Virology.
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Regulatory front for April 28, 2020

April 28, 2020
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The latest global regulatory news, changes and updates affecting medical devices and technologies, including: Health Quality Ontario, Imagination Engines.
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Regulatory action for April 28, 2020

April 28, 2020
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Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Chronolife, Edwards Lifesciences, Exthera, Icecure, Life Spine, Lungpacer Medical, Medipines.
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Regulatory actions for April 28, 2020

April 28, 2020
No Comments
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Adaptimmune, Bioeclipse, Moderna, Moleculin, Pharmamar, Retrotope, Roche, Sanofi, Shionogi, Zambon.
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Regulatory front for April 28, 2020

April 28, 2020
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The latest global regulatory news, changes and updates affecting biopharma, including: Chugai, Fresenius, Genentech, Pfizer, Quva, Roche, Vertex.
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Braintale software

Braintale gains CE mark approval for its first quantitative brain measurement device

April 27, 2020
By Bernard Banga
No Comments
PARIS – Braintale SAS, of Paris, has gained CE mark approval for Brainquant. This software platform, which uses DICOM radiology imaging, enables diffusion MRI scans to be processed as part of managing patients in a coma following brain injury.
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Regulatory front for April 27, 2020

April 27, 2020
No Comments
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: Apollo Endosurgery, Ariosa, Illumina, Roche, Verinata Health.
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Regulatory action for April 27, 2020

April 27, 2020
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Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abbott, Livanova, Personal Genome Diagnostics.
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Steadying hand while reaching for glass

Neurocrine expands commercial portfolio, winning U.S. approval for Parkinson's drug

April 27, 2020
By Michael Fitzhugh
No Comments
A once-daily add-on therapy for Parkinson's disease (PD) used in Europe for years has now gained clearance in the U.S. with FDA approval of Ongentys (opicapone). The drug, an improvement upon generics in its class, will be sold by Neurocrine Biosciences Inc. The medicine, a catechol-O-methyltransferase (COMT) inhibitor first approved by the EMA in 2016, extends the half-life of levodopa, increasing doses of which are required to achieve motor control as PD progresses. Portugal-based Bial-Portela & Ca SA, from which Neurocrine licensed North American rights to the drug, will receive a $20 million award from its partner. Shares of San Diego-based Neurocrine (NASDAQ:NBIX), a neuroscience company focused on treating movement disorders, rose 3.5% following the approval, closing at $101.67 on April 27.
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