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Regulatory
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Obesity and heart disease illustration

FDA clears GT Metabolic’s magnetic bariatric surgery system

Oct. 30, 2024
By Annette Boyle
GT Metabolic Solutions Inc. received U.S. FDA clearance for its Magdi bariatric surgery system. The system uses magnets to create side-to-side duodeno-ileal anastomosis without cutting intestinal tissue or leaving foreign materials in the body permanently.
Read More
Hands holding tablet and glass of water

Lexicon looks to go where no other oral drug has gone before

Oct. 29, 2024
By Mari Serebrov
Lexicon Pharmaceuticals Inc. is counting on the Oct. 31 meeting of the U.S. FDA’s Endocrinologic and Metabolic Drugs Advisory Committee to help it break through the type 1 diabetes (T1D) door with Zynquista (sotagliflozin), proposed as an adjunct to insulin to improve glycemic control in people with T1D and mild to moderate chronic kidney disease.
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Astellas withdraws its EU MAA for geographic atrophy

Oct. 29, 2024
By Tamra Sami
Astellas Pharma Inc. has withdrawn its marketing authorization application from the EMA for its avacincaptad pegol intravitreal solution for the treatment of geographic atrophy secondary to age-related macular degeneration. “The company's decision to withdraw its application followed interactions” with the EMA’s Committee for Medicinal Products for Human Use, an Astellas spokesperson told BioWorld.
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Dae chul CHOI CEO Ngenebio

Ngenebio launches RNA diagnostic panel for solid tumor detection

Oct. 29, 2024
By Marian (YoonJee) Chu
Ngenebio Co. Ltd. launched a precision diagnostic panel called Oncoaccupanel RNA in South Korea Oct. 29 as a test to detect oncogenic fusion genes commonly found in solid tumors.
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US CRS weighs in on improving gene therapy regulatory landscape

Oct. 28, 2024
By Mari Serebrov
Although more and more gene therapies are getting the FDA stamp of approval, concerns persist about their potential long-term risks. U.S. lawmakers have proposed several pieces of legislation over the past few years to address some of the uncertainties. Now the Congressional Research Service (CRS) is suggesting other requirements Congress may want to consider to improve the regulatory landscape for gene therapies, especially those intended to treat blood disorders.
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Robert Califf with American flag

FDA’s Califf: Misinformation an emergency, docs must weigh in

Oct. 28, 2024
By Mark McCarty
FDA commissioner Bob Califf made it his mission to counter medical and food product misinformation, and described the dilemma as an emergency at an Oct. 28 public meeting.
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Johns Hopkins Medicine surgeons performing a kidney transplant.

Paragonix’s Kidney Vault receives FDA nod for organ transport

Oct. 28, 2024
By Annette Boyle
The U.S. FDA cleared Paragonix Technologies Inc.’s Kidneyvault portable renal perfusion system, which combines digital monitoring capabilities and hypothermic perfusion technology to preserve donor kidneys during transportation.
Read More
Illustration of the neuromuscular junction
Neurology/psychiatric

MDA’s Kickstart program announces orphan drug designation for congenital myasthenic syndrome

Oct. 28, 2024
The Muscular Dystrophy Association (MDA)’s Kickstart program has announced receipt of both U.S. orphan drug and rare pediatric disease designations in support of work for congenital myasthenic syndrome caused by choline acetyltransferase (CHAT) gene deficiency. The FDA awarded the orphan drug designation to AVCHAT-01X (AAV serotype 9 human choline acetyltransferase).
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RNA strand
Ear, nose & throat

Ribox’s RXRG-001 cleared to enter clinic for radiation-induced xerostomia and hyposalivation

Oct. 28, 2024
Ribox Therapeutics Ltd. has obtained IND clearance from the FDA for the company’s circular RNA therapy, RXRG-001.
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3D illustration of cancer in crosshairs
Cancer

WRN inhibitor IDE-275 gains IND clearance for phase I study in MSI-high tumors

Oct. 28, 2024
Ideaya Biosciences Inc. has announced FDA clearance of an IND application for IDE-275 (GSK-959), a small-molecule inhibitor of Werner helicase (WRN) discovered by Ideaya in collaboration with GSK plc.
Read More
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