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BioWorld - Thursday, March 23, 2023
Home » Topics » Regulatory

Regulatory
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Will the lessons of COVID-19 be taken to heart this time?

Aug. 13, 2020
By Mari Serebrov
No Comments
Amid all the political positioning, finger-pointing, blame games and mountains of misinformation that have been as much a part of the COVID-19 pandemic as the coronavirus itself, there’s one point of agreement: The pandemic has been a painful experience that everyone needs to learn from so it’s not repeated in the future.
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Regulatory front for Aug. 13, 2020

Aug. 13, 2020
No Comments
The latest global regulatory news, changes and updates affecting medical devices and technologies.
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Regulatory actions for Aug. 13, 2020

Aug. 13, 2020
No Comments
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: 4D Molecular Therapeutics, Bayer, Hyperfine, Inmode, Osprey Medical, Quidel, RapidAI, Spectronrx.
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Regulatory actions for Aug. 13, 2020

Aug. 13, 2020
No Comments
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: 4D Molecular, Akeso, Antengene, Biomarin, Enzychem, Genentech, Hoth, Micurx, NS, Passage, Scholar Rock, TG.
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Hospital ICU, patient, monitor

Baxter nabs EUAs to address kidney injury in COVID-19 patients

Aug. 12, 2020
By Meg Bryant
No Comments
The U.S. FDA has granted emergency use authorizations (EUAs) to Baxter International Inc. for its HF20 Set and ST Set used in continuous renal replacement therapy (CRRT) during the COVID-19 pandemic. The two sets are intended for use with the company’s Prismaflex or Prismax CRRT monitors.
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Stock chart, compass

‘Bearing’ down: With the NRF2 persist after dicey FDA updates, Reata well enough left -olone?

Aug. 12, 2020
By Randy Osborne
No Comments
Wall Street dinged Reata Pharmaceuticals Inc. earlier this week after mixed regulatory news on the nuclear factor erythroid-2 related factor 2 (NRF2) activators omaveloxolone for Friedreich’s ataxia (FA) and bardoxolone for Alport syndrome (AS), but the Plano, Texas-based firm stayed resolute, and its recent deal with Blackstone Life Sciences (BXLS) provides cause for optimism. Increased clarity on paths forward “debunks the bear-case view” of Reata, in the opinion of Jefferies analyst Maury Raycroft, who went as far as to say in a report that the stock “overreaction create[d] a buying opportunity.”
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Will the lessons of COVID-19 be taken to heart this time?

Aug. 12, 2020
By Mari Serebrov
No Comments
Amid all the political positioning, finger-pointing, blame games and mountains of misinformation that have been as much a part of the COVID-19 pandemic as the coronavirus itself, there’s one point of agreement: The pandemic has been a painful experience that everyone needs to learn from so it’s not repeated in the future.
Read More
Product image

FDA gives thumbs up to Synergy for HBR indication

Aug. 12, 2020
By Liz Hollis
No Comments
Boston Scientific Corp. has received the U.S. FDA’s nod for a high bleeding risk (HBR) indication for the Synergy drug-eluting stent system.
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Regulatory actions for Aug. 12, 2020

Aug. 12, 2020
No Comments
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Baxter, Lantheus.
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Regulatory front for Aug. 12, 2020

Aug. 12, 2020
No Comments
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: American Medical Association, Bayer AG, Snomed International.
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