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Regulatory actions for Feb. 28, 2023

Feb. 28, 2023
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abbvie, Amo, Asklepios, Biophytis, Glaukos, Orchard, PDS, Priothera, Replimune, Springworks.
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FDA says Abbott Trifecta valves may be susceptible to early deterioration

Feb. 27, 2023
By Mark McCarty
The U.S. FDA announced Feb. 27 that it is aware of data that suggest that the Trifecta surgical aortic valve replacement (SAVR) devices are potentially prone to early structural deterioration that could compromise both valve performance and valve durability.
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Medtech Europe wary of overlap from EU’s health data space initiative

Feb. 27, 2023
By Mark McCarty
The European Health Data Space (EHDS) proposal is designed to standardize practices for transmission and other sharing of health information, but this proposal is far from the only significant development coming out of Brussels.
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Reata hit with investor uncertainty as FDA’s Dunn steps down

Feb. 27, 2023
By Jennifer Boggs
Shares of Reata Pharmaceuticals Inc. tanked unexpectedly Feb. 27, a day before the U.S. FDA is set to make a decision on the NDA seeking approval of once-daily Nrf2 activator omaveloxolone for Friedreich’s ataxia, on reports that Billy Dunn, the director of the FDA’s Office of Neuroscience, was stepping down from his position.
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First RSV vaccines on tap for US adcom

Feb. 27, 2023
By Mari Serebrov
Safety likely will be top of mind when the U.S. FDA’s Vaccines and Related Biologic Products Advisory Committee meets Feb. 28 and March 1 to advise the agency on two respiratory syncytial virus (RSV) vaccines proposed for use in adults who are at least 60 years old.
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Rare disease illustration

Ethical considerations open FDA’s Rare Disease Day

Feb. 27, 2023
By Lee Landenberger
The U.S. FDA marked the 40th anniversary of the Orphan Drug Act with Rare Disease Day 2023 as Robert Califf, the agency’s commissioner of food and drugs, opened the day by expressing his wonder and accompanying concern regarding gene editing and gene therapy.
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Fed Circuit orders Jazz to delist REMS patent

Feb. 27, 2023
By Mari Serebrov
While the FDA has yet to take a stance on whether risk evaluation and mitigation strategy (REMS) patents can be listed in its Orange Book, the U.S. Court of Appeals for the Federal Circuit weighed in Feb. 24 with a decisive “no” when those patents only claim a system.
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Regulatory actions for Feb. 27, 2023

Feb. 27, 2023
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Apyx Medical, Lucira Health, Milestone Scientific.
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Regulatory actions for Feb. 27, 2023

Feb. 27, 2023
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Akebia, Astrazeneca, Beigene, Chiesi, Daiichi Sankyo, Incyte, Janssen, Merck, Protalix, Regeneron, Ridgeback, Servier, Sobi, Timber.
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Illustration of Aurora EV-ICD in chest

Medtronic CE mark receipt strengthens cardiac rhythm business

Feb. 24, 2023
By Shani Alexander
Medtronic plc recently received the CE mark for its Aurora extravascular implantable cardioverter-defibrillator (EV-ICD) strengthening its cardiovascular portfolio which saw a 7% year-on-year growth in the third quarter of its fiscal year 2023.
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