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Home » Topics » Regulatory

Regulatory
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New Japan drug approvals: cancer, insomnia, Alzheimer’s and more

Sep. 26, 2024
By Marian (YoonJee) Chu
Japan’s Ministry of Health, Labour and Welfare granted new drug approvals and expanded indications for conditions like cancer, insomnia and Alzheimer’s disease (AD) Sept. 24, including Eli Lilly and Co.’s Kisunla (donanemab) for early symptomatic AD.
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Document signing

FDA, Irhythm see different triggers for medical device reports

Sep. 26, 2024
By Mark McCarty
The U.S. FDA’s inspection of two facilities run by San Francisco-based Irhythm Technologies Inc., illuminated some of the usual problems with corrective and preventive action. The agency indicated that problems with skin irritation associated with the company’s Zio device should have been handled as medical device reports, a view the company apparently did not share.
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Gastrointestinal system with ulcerative colitis.
Gastrointestinal

Palisade submits CTA for PDE4 inhibitor prodrug for ulcerative colitis

Sep. 26, 2024
Palisade Bio Inc. has submitted a clinical trial application (CTA) for PALI-2108 for the treatment of ulcerative colitis, following a pre-CTA consultation meeting with Health Canada. Pending clearance, the company anticipates initiating a phase I study by year-end.
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Purple-tinted test tubes and dropper
Immune

FDA awards orphan status to Eydisbio’s TAK1 inhibitor

Sep. 26, 2024
The FDA has awarded U.S. orphan drug designation to Eydisbio Inc.’s EYD-001 (formerly HS-276), a highly selective and potent, orally bioavailable TAK1 inhibitor for the treatment of systemic sclerosis. Eydisbio plans to initiate clinical trials in the near future.
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Product recall concept image

Baxter recalls compounding inlets for Exactomix systems

Sep. 25, 2024
By Mark McCarty
The U.S. FDA announced a class I recall declared by Baxter Healthcare Corp., of Deerfield, Ill., for the automated compounding inlets used with the company’s Exactomix compounding systems due to the risk of particulate matter in the inlets.
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U.S. flag on columned building

Vascular Solutions-Medtronic patent scrum remanded to district court

Sep. 25, 2024
By Mark McCarty
The U.S. Court of Appeals for the Federal Circuit remanded a patent case to district court after finding that a patent applicant need not invoke identical terminology when describing a central feature of a catheter technology across multiple patents.
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Approved label with medical icons, professional

Take your (Niemann-) Pick: Intrabio’s Aqneursa wins FDA nod

Sep. 25, 2024
By Randy Osborne
With two drugs cleared by the U.S. FDA for Niemann-Pick disease type C (NPC) in less than seven days, Wall Street was pondering the differences between the compounds, given what’s known so far about each. Most recently, the FDA approved Intrabio Inc.’s Aqneursa (levacetylleucine) on its PDUFA date for the treatment of neurological manifestations of NPC in adults and pediatric patients weighing at least 15 kg, making Aqneursa the only approved stand-alone therapy indicated for NPC. On Sept. 20, Zevra Therapeutics Inc. won FDA clearance for Miplyffa (arimoclomol) as the first treatment for NPC.
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Immuno-oncology art concept
Immuno-oncology

KSQ Therapeutics’ TIL therapy cleared to enter clinic for solid tumors

Sep. 25, 2024
The FDA has cleared an IND application for a phase I/II study of KSQ-004EX, KSQ Therapeutics Inc.’s second engineered tumor-infiltrating lymphocyte (eTIL) program. KSQ-004EX consists of TIL in which the genes encoding SOCS1 and Regnase-1 are inactivated using CRISPR/Cas9 gene editing.
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Endocrine/metabolic

Arrowhead seeks clearance to advance ARO-INHBE into clinic for obesity

Sep. 25, 2024
Arrowhead Pharmaceuticals Inc. has filed for regulatory clearance to initiate a phase I/IIa trial of ARO-INHBE, the company’s investigational RNA interference (RNAi) therapeutic being developed for obesity.
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ODAC to explore PD-L1 levels’ limit case in PD-1 therapy

Sep. 24, 2024
By Randy Osborne
The U.S. FDA’s Oncologic Drugs Advisory Committee (ODAC) on Sept. 26 will take up a controversy that’s hardly new: whether approval of immune checkpoint inhibitor drugs should be restricted in accordance with PD-L1 expression.
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