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Regulatory actions for April 27, 2022

April 27, 2022
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Editas, Evoke, Gamdia, Gilead, Lemonex, OncoC4, Pharming, VBL.
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Cardio AI software

Arterys wins eighth FDA clearance for enhanced deep learning MRI

April 26, 2022
By David Godkin
Yes, getting FDA 510(k) clearance for your medical device is something to cheer about. But consider Arterys Inc. It just reported its eighth FDA clearance, this time for a next generation, deep learning cardiac analytics platform. The Cardio AI’s purpose, Arterys CEO John Axerio-Cilies told BioWorld, is to leverage artificial intelligence (AI) and deep learning for analysis of cardiac MRI images that is faster, more accurate and repeatable than ultrasound and other imaging modalities.
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3D illustration of heart cross section

Venus Medtech’s TPVR product gains CE mark

April 26, 2022
By Zhang Mengying
Venus Medtech (Hangzhou) Inc.’s Venusp-Valve, a transcatheter pulmonic valve replacement (TPVR) system, has gained the CE mark in Europe. The system is used to treat moderate to severe pulmonary regurgitation with or without right ventricular outflow tract stenosis. The TPVR provides an alternative for those not eligible for open-chest operations because of the risks such as large trauma, and slow recovery, a spokesperson of Venus Medtech told BioWorld.
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Magnifying glass, FDA concept image

US FDA hammered over user fee accountability

April 26, 2022
By Mari Serebrov
In the second of two hearings before the U.S. Senate Health, Education, Labor and Pensions Committee on the next iteration of the FDA drug and device user fee agreements, the focus was supposed to be on advancing regulation and innovation. But Ranking Member Richard Burr (R-N.C.) shifted the spotlight April 26 to accountability in his opening remarks and subsequent questioning.
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Regulatory actions for April 26, 2022

April 26, 2022
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Dib Ultranav Medical, Franklin Mountain Medical.
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Regulatory actions for April 26, 2022

April 26, 2022
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Ardelyx, Astrazeneca, Autolus, Langsheng, Merck & Co., Obseva, Priothera, Quoin, Roche, Sol-Gel, Sorrento, Valneva.
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US FDA approves first COVID-19 antiviral for young children

April 25, 2022
By Mari Serebrov
There may be no COVID-19 vaccines authorized yet in the U.S. for the youngest children, but there’s now an approved treatment for some children who are already sick with an infection.
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Regulatory actions for April 25, 2022

April 25, 2022
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Conextions.
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Health Canada lays out rules for labeling links

April 25, 2022
By Mari Serebrov
Links to electronic information may become a more common feature in Canadian prescription drug labeling, but electronic labeling is not expected to replace paper labels anytime soon.
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Filling in the gaps, US FDA to look at drug tradeoffs for patients, doctors

April 25, 2022
By Mari Serebrov
Recognizing that patient views about the tradeoffs of using one drug over another may differ from those of doctors, the U.S. FDA’s Office of Prescription Drug Promotion is proposing to examine those tradeoffs in an analysis involving fictitious prescription drugs for type 2 diabetes and psoriasis.
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