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Home » Topics » Regulatory

Regulatory
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Regulatory actions for Oct. 10, 2023

Oct. 10, 2023
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Acousia, Alnylam, Aquestive, Canbridge, Jasper, Novartis, Okyo, Radiopharm, Tonix, Ultimovacs.
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2023 Med Tech Conference

Congress seen as having leeway to bring LDT user fees on board midstream in MDUFA VI

Oct. 9, 2023
By Mark McCarty

The U.S. FDA’s draft rule for regulation of lab-developed tests (LDTs) carries an exceptionally ambitious timeline of completion and enactment by the time the next user fee agreement kicks in, and some see big problems with the timeline laid out by the agency. However, the FDA’s Elizabeth Hillebrenner said that Congress can tweak user fee legislation such that a specific set of user fee sources kicks in off schedule, thus giving the agency a little more leeway in completing any activity related to the proposed rule.


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Inbrain graphene-based cortical brain interface

Inbrain granted breakthrough device designation for graphene-based neural platform

Oct. 9, 2023
By Shani Alexander

Inbrain Neuroelectronics SL was granted a breakthrough device designation from the U.S. FDA for its graphene-based neural platform as an adjunctive therapy for treating Parkinson’s disease. The platform, called intelligent network modulation system, harnesses the power of graphene and artificial intelligence to deliver highly focused, adaptive neuroelectronic therapy that re-balances pathological neural networks, easing the symptoms of Parkinson’s.


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Electric-field directed nerve regeneration
Patents

USC researchers develop technique for electric field directed optic nerve regeneration

Oct. 9, 2023
By Simon Kerton
The University of Southern California (USC) reported filing a patent for a retinal ganglion cell (RGC) stimulation system in which electrodes may be placed in, around or near sites of optic nerve injury to generate electric fields that can direct the direction of axonal regeneration.
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Regulatory actions for Oct. 9, 2023

Oct. 9, 2023
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Endotronix, Foundation Medicine, Histosonics, Hyperfine .
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Alnylam pulls back on new Onpattro indication after surprise CRL

Oct. 9, 2023
By Mari Serebrov
Following an unexpected FDA complete response letter (CRL), Alnylam Pharmaceuticals Inc. said it will no longer pursue an expanded indication for Onpattro (patisiran) in the U.S. The RNAi therapeutic was approved in 2018 to treat polyneuropathy of hereditary transthyretin-mediated (ATTR) amyloidosis and seemed well on its way to snagging a second U.S. indication after the FDA’s Cardiovascular and Renal Drugs Advisory Committee voted 9-3 in September that the drug’s benefits outweighed its risks as a treatment for cardiomyopathy of ATTR amyloidosis. The FDA disagreed with the committee, saying in the CRL that patisiran’s clinical meaningfulness had not been established in the proposed indication.
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Regulatory actions for Oct. 9, 2023

Oct. 9, 2023
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Amylyx, Arcutis, ARS, GC, Janssen.
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Regulatory actions for Oct. 6, 2023

Oct. 6, 2023
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Agomab, Biomea Fusion, Cel-Sci, Calliditas, Coherus Biosciences, Innate.
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Easymotionskin electromyostimulation
Patent

Easymotionskin reveals a wearable device for treating urinary incontinence to rival Elidah’s Elitone device

Oct. 6, 2023
By Simon Kerton
Easymotionskin Tec AG is seeking patent protection for a wearable product that delivers transcutaneous electromyostimulation (EMS) of pelvic floor musculature through the body’s perineum, for the non-invasive treatment of incontinence, particularly stress incontinence. The invention is said to be suited to nearly all patients, including those patients who cannot insert anal or vaginal probes that provide pelvic floor training by EMS.
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Blood clot blocking a blood vessel
Hematologic

GC Biopharma’s GC-1126A awarded US orphan drug designation for thrombotic thrombocytopenic purpura

Oct. 6, 2023
The FDA has awarded orphan drug designation to GC Biopharma Corp.’s GC-1126A for thrombotic thrombocytopenic purpura (TTP).
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