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Regulatory
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Laptop displaying FDA logo

FDA draft for third-party EUA reviews lacks timeline commitments

Jan. 30, 2024
By Mark McCarty
The U.S. FDA has redrafted an existing guidance for third-party reviews of 510(k) submissions to include submissions under the emergency use authorization (EUA) program, which generally speaking should be good news. The problem with the draft is that these third parties will have to interact frequently and substantively with the FDA in EUA reviews, and the lack of prescribed timelines in the FDA draft suggests that while the use of third parties may help the agency manage any future EUA workloads, the total turnaround time for these applications might not be significantly better than was seen during the COVID-19 pandemic.
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Phillips Recall Mask BiPAP CPAP

Philips consent decree with FDA will halt sales of sleep apnea devices

Jan. 30, 2024
By Shani Alexander
Royal Philips NV agreed with the U.S. FDA to the terms of a consent decree focused on its Respironics business, following the recall of millions of its devices over the last few years. Although the details of the decree are being finalized, Philips said it will halt the sales of new continuous positive airway pressure (CPAP) and bilevel positive airway pressure (BiPAP) sleep therapy machines as well as other respiratory care devices in the U.S. until the conditions of the decree are met.
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Illustration of the inside of an eye with macular degeneration
Ocular

Ascidian’s RNA exon editor cleared to enter clinic for Stargardt disease

Jan. 30, 2024
Ascidian Therapeutics Inc. has received FDA clearance of its IND application for ACDN-01, an RNA exon editor targeting the genetic cause of Stargardt disease.
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US FDA expands guidance on race, ethnicity data in trials

Jan. 29, 2024
By Mari Serebrov
In keeping with federal standards for classifying race and ethnicity data, the U.S. FDA issued a draft revision to broaden its 2016 guidance on the collection of such data in clinical trials.
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Product image

FDA accepts Novocure’s PMA application for lung cancer treatment technology

Jan. 29, 2024
By Shani Alexander
The U.S. FDA accepted Novocure GmbH’s premarket approval (PMA) application to use its Tumor Treating Fields (TTFields) technology together with standard systemic therapies to treat non-small cell lung cancer (NSCLC) following progression on or after platinum-based therapy. Novocure hopes that the application, under review, will get the green light and the therapy, which uses electric fields to disrupt solid tumors and kill cancer cells, will be on the market in the second half of 2024.
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Neurolace

FDA clears non-invasive Neuralace therapy for diabetic neuropathy

Jan. 29, 2024
By Annette Boyle
Neuralace Medical Inc. tied up a second U.S. FDA clearance for its Axon therapy, adding painful diabetic neuropathy (PDN) to the chronic nerve pain indication it received in 2021. An ‘electroceutical’ device, Axon employs non-invasive magnetic peripheral nerve stimulation (mPNS) to provide relief without leads, injections or implants.
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Dupixent

US FDA clears Dupixent for children with eosinophilic esophagitis

Jan. 26, 2024
By Karen Carey
Becoming the first treatment for children ages 1 to 11 with eosinophilic esophagitis (EE), Sanofi SA and Regeneron Pharmaceuticals Inc.’s IL-4/IL-13 inhibitor Dupixent (dupilumab) was cleared by the U.S. FDA on Jan. 25.
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Flag of South Korea with skyscrapers in the background

Genexine files for Korea approval of Efesa for CKD-linked anemia

Jan. 26, 2024
By Marian (YoonJee) Chu
Seoul-based Genexine Inc. filed a BLA to gain domestic approval of its follow-on biologic for chronic kidney disease (CKD)-induced anemia, Efesa (efepoetin alfa, GX-E4), to South Korean health regulators on Jan. 25.
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EMA pulling Translarna off market for Duchenne muscular dystrophy

Jan. 26, 2024
By Nuala Moran
After almost 10 years on the market, the EMA is to withdraw its conditional approval of the Duchenne muscular dystrophy treatment Translarna (ataluren), after concluding there is still not enough evidence of its effectiveness.
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LIBERTA DBS

FDA frees Abbott’s Liberta RC DBS system for use

Jan. 25, 2024
By Annette Boyle
Abbott Laboratories received U.S. FDA approval for its Liberta RC deep brain stimulation (DBS) system for use in movement disorders, less than two weeks after the agency gave its nod to Medtronic’s Percept RC DBS system. The news come on the heels of Abbott’s release of strong fourth quarter results on Wednesday.
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