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BioWorld - Saturday, March 6, 2021
Home » Topics » Regulatory

Regulatory
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Smartphone showing Vocalis mobile app

Speak up! Voice sample provides accurate screen for COVID-19

Feb. 23, 2021
By Annette Boyle
No Comments
"Step up, speak up" could be the next mantra for COVID-19 screening at airports, universities and large employers if Vocalis Health Inc.'s screening tool takes off – and its recent CE mark approval makes that more likely. Vocalis reported that a large study found the tool, which uses AI-powered vocal biomarkers, had greater than 80% sensitivity and specificity, even in asymptomatic individuals.
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Regulatory front for Feb. 23, 2021

Feb. 23, 2021
By Mark McCarty
No Comments
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: OIG: Noridian overpaid for facet-joint injections; Hill-Rom patient lift recalled; New legislation directed to heart valve disease.
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Regulatory actions for Feb. 23, 2021

Feb. 23, 2021
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Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Endoclot Plus, Inova Diagnostics, Newronika, Rhythmlink.
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In congressional update, vaccine makers stress manufacturing complexity

Feb. 23, 2021
By Mari Serebrov
No Comments
In the shadow of the COVID-19-related deaths of more than half a million Americans and far more deaths across the world, the Biden administration is reportedly rethinking its position on a proposal before the World Trade Organization to waive intellectual property protection for SARS-CoV-2 vaccines.
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Regulatory front for Feb. 23, 2021

Feb. 23, 2021
No Comments
The latest global regulatory news, changes and updates affecting biopharma.
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Regulatory actions for Feb. 23, 2021

Feb. 23, 2021
No Comments
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Agilent, Elicio, Hoth, Iaso, Innovent, Neoimmunetech, Noven, Ocugen, RDIF, Regeneron, Sanofi, Scpharmaceuticals.
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Product image

Brainlab wins FDA nod for mobile imaging robot, surgical alignment tool

Feb. 22, 2021
By Meg Bryant
No Comments
The U.S. FDA has given a green light to Brainlab AG for two new additions to its robotic surgery systems. The agency granted 510(k) clearances for the Loop-X mobile imaging robot and the Cirq Robotic Alignment module for spine procedures, paving the way for U.S. market entry.
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Brainstorm to brainstorm on BLA filing in ALS

Feb. 22, 2021
By Lee Landenberger
No Comments
Brainstorm Cell Therapeutics Inc. said FDA senior leadership told the company the level of clinical data in the Nurown (neurotrophic factor-producing mesenchymal stem cells) phase III trial in amyotrophic lateral sclerosis (ALS) does not provide the threshold of substantial evidence needed to support a BLA.
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Keeping up with the variants: FDA releases suite of guidance

Feb. 22, 2021
By Mari Serebrov
No Comments
COVID-19 vaccine developers should begin testing their vaccines against emerging variants now and assessing booster regimens, the FDA said in an update to its October guidance on emergency use authorizations (EUAs) for the vaccines.
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Regulatory actions for Feb. 22, 2021

Feb. 22, 2021
No Comments
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Adamis, Amgen, Astrazeneca, Brainstorm, Cassava, Celsion, Curocell, Intra-Cellular, Junshi, Supernus, Zosano.
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