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BioWorld - Tuesday, July 5, 2022
Home » Topics » Regulatory

Regulatory
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Axsome receives proposed US FDA labeling for AXS-05

June 27, 2022
By Lee Landenberger
No Comments
Axsome Therapeutics Inc. and the U.S. FDA appear to be working out their differences. The company said it received the proposed labeling from the agency for AXS-05 (dextromethorphan + bupropion), an oral NMDA receptor antagonist with multimodal activity, for treating major depressive disorder.
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VRBPAC to prognosticate on US COVID-19 vaccines

June 27, 2022
By Mari Serebrov
No Comments
Armed with data but no crystal ball, the U.S. FDA’s Vaccines and Related Biologic Products Advisory Committee (VRBPAC) will be asked June 28 to predict the next-generation vaccines that will be needed to best respond to the COVID-19 futurescape. While Moderna Inc., Pfizer Inc. and Novavax Inc. will briefly present clinical data for their variant vaccines at the VRBPAC meeting, the discussion will be about the future of all COVID-19 vaccines being developed or authorized for the U.S. market.
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Astellas sees another US FDA clinical hold for AAV gene therapy trial

June 27, 2022
By Tamra Sami
No Comments
The U.S. FDA has placed a clinical hold on Astellas Pharma Inc.’s Fortis phase I/II trial evaluating AT-845 following a serious adverse event of peripheral sensory neuropathy in one of the trial participants. AT-845 is an adeno-associated virus (AAV) gene replacement therapy being studied in adults with late-onset Pompe disease.
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Taiho picks up nod for Jeselhy to treat gastrointestinal stromal tumors in Japan

June 27, 2022
By Doris Yu
No Comments
Japan’s Ministry of Health, Labour and Welfare has given Otsuka Holdings Co. Ltd. subsidiary Taiho Pharmaceutical Co. Ltd. the green light for its oral heat shock protein 90 (HSP90) inhibitor Jeselhy (pimitespib) to treat gastrointestinal stromal tumors (GIST) that have progressed after chemotherapy. The company will soon commercialize the drug in Japan.
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Regulatory actions for June 27, 2022

June 27, 2022
No Comments
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Acutus Medical.
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Regulatory actions for June 27, 2022

June 27, 2022
No Comments
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Adverum, Amryt, Argenx, Basilea, Biomarin, Croma, Cytokinetics, Daewoong, Emergent, Gilead, Janssen, Kyowa Kirin, Merck, Novartis, Novavax, Oncopeptides, Sarepta.
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BD recalls intraosseous needle set kits, power drivers

June 24, 2022
By Mark McCarty
No Comments
Becton, Dickinson & Co. (BD) recalled intraosseous needle set kits and power drivers. The action was triggered by difficulties in separating the stylet from the needle. The FDA also announced a class I recall of the Volara respiratory clearance system by Baxter Healthcare Corp., of Deerfield, Ill., because of issues with an in-line ventilator adapter.
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AI harmonization is key for companies as regulators continue brewing new rules

June 24, 2022
By Mark McCarty
No Comments
Regulatory harmonization of artificial intelligence (AI) and machine learning (ML) is high on the checklist for companies that want to develop these products, but legislatures and regulatory agencies across the globe seem less interested. Koen Cobbaert, senior manager for quality standards and regulation with Royal Philips NV, told BioWorld that there is a race on to be the first market with a full-fledged set of regulations, a fact of life that does little to advance the cause of harmonization.
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FDA rejects Artrya’s 510(k) for its AI-enabled Salix coronary anatomy software

June 24, 2022
By Tamra Sami
No Comments
The FDA has rejected Artrya Ltd.’s 510(k) application for its Salix coronary anatomy (SCA) software that analyzes heart computed tomography scans via artificial intelligence (AI) to better diagnose coronary artery disease. “The FDA has advised that the Artrya Salix product is not equivalent to the predicate device,” Artrya CEO John Barrington told BioWorld.
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Regulatory actions for June 24, 2022

June 24, 2022
No Comments
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Paige.
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