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Home » Topics » Regulatory

Regulatory
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Neurology/psychiatric

Luye advances dual agonist for schizophrenia, Alzheimer’s

Aug. 12, 2024
By Tamra Sami
China’s National Medical Products Administration has cleared Luye Pharma Group Ltd.’s new schizophrenia candidate LY-03020 to enter phase I trials in China. Independently developed by Shanghai-based Luye, the new chemical entity is a dual agonist that targets both the trace amine-associated receptor 1 and the 5-HT2C receptor and is intended to treat schizophrenia and Alzheimer’s disease psychosis.
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Multiple sclerosis-damaged myelin
Neurology/psychiatric

Azer-cel gets IND clearance in multiple sclerosis

Aug. 12, 2024
Precision Biosciences Inc. has announced that its experimental allogeneic T cell therapy azercabtagene zapreleucel (azer-cel) for the treatment of multiple sclerosis (MS) has received IND clearance from the FDA.
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3D rendering of CAR T therapy in cell
Immune

BCMA-targeting CAR T cell cleared for clinic by China’s NMPA

Aug. 12, 2024
CSPC Pharmaceutical Group Ltd. has received clearance from China’s National Medical Products Administration (NMPA) to conduct clinical trials in China with its BCMA-targeting CAR T cell SYS-6020 for systemic lupus erythematosus (lupus) in China.
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Product recall concept image

Smith’s Medical, Medtronic report product recalls

Aug. 9, 2024
By Mark McCarty
Minneapolis-based Smiths Medical Inc., recalled two entries in the company’s CADD-Solis line of ambulatory infusion pumps due to problems with the preloaded software.
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Neural network
Musculoskeletal

Actio’s ABS-0871 gets orphan, rare pediatric disease designations

Aug. 9, 2024
Actio Biosciences Inc.’s ABS-0871 has received both orphan drug designation and rare pediatric disease designation from the FDA. ABS-0871 is in preclinical development for the treatment of Charcot-Marie-Tooth disease subtype 2C (CMT2C).
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Art concept for inflammation in the intestines
Gastrointestinal

TRX-103 cleared for clinic in treatment-refractory Crohn’s disease

Aug. 9, 2024
Tr1x Inc. has announced that the FDA has cleared its IND application for its engineered Tr1 Treg cell therapy TRX-103 for treatment-refractory Crohn’s disease.
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Yes, IGaN: Novartis’ proteinuria therapy receives FDA approval

Aug. 8, 2024
By Lee Landenberger
The U.S. FDA has granted accelerated approval to Novartis AG’s Fabhalta (iptacopan) for reducing proteinuria in adults with primary immunoglobulin A nephropathy (IgAN) at risk of rapid disease progression. The approval strengthens the company’s renal disease presence as it puts two other IgAN treatments through clinical trials.
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3D map of China

China to deepen health care reforms to increase primary care capacity

Aug. 8, 2024
By Tamra Sami
China will deepen its health care reforms and will focus on enhancing its public health care capacity at the primary care level and at public hospitals, according to resolutions passed at the third plenary session of the 20th Central Committee of the Communist Party of China in July.
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Medicare puzzle

US Medicare’s TCET final fuzzy on definition of ‘similar device’

Aug. 8, 2024
By Mark McCarty
The U.S. CMS announced the release of the Transitional Coverage for Emerging Technologies policy, which is less than clear on the definition of a key term.
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3-30-fractyl-revita.png

Fractyl says ablation provides sustained weight loss

Aug. 8, 2024
By Annette Boyle
Twelve-month results from Fractyl Health Inc.’s real-world registry show sustained, significant weight loss following treatment with its Revita procedure, which uses ablation to resurface the mucosal lining of the duodenum.
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