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Regulatory
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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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FDA approved icons and medical professional

New Ontak on track as Citius wins FDA’s nod for Lymphir in CTCL

Aug. 8, 2024
By Randy Osborne
Just ahead of the Aug. 13 PDUFA date, Citius Pharmaceuticals Inc. won the U.S. FDA’s go-ahead for Lymphir (denileukin diftitox-cxdl), a new immunotherapy for relapsed/refractory (r/r) cutaneous T-cell lymphoma (CTCL) after at least one prior systemic therapy. The drug is Cranford, N.J.-based Citius’ first approved therapy and the only CTCL treatment that targets the interleukin-2 receptor found on malignant T cells and regulatory T cells. It’s also the first green light given by the FDA for r/r CTCL since 2018.
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Boy in wheelchair, scenic overlook
Musculoskeletal

SAT-3247 adds rare pediatric disease designation

Aug. 8, 2024
After receiving Orphan Drug Designation earlier this year, Satellos Bioscience Inc. announced that the FDA has granted Rare Pediatric Disease Designation to SAT-3247 for the potential treatment of Duchenne muscular dystrophy (DMD).
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Cancer

Westgene therapeutic vaccine cleared for clinic in US, China

Aug. 8, 2024
Chengdu Westgene Biopharma Co. Ltd. (Westgene) has received approval from both China's National Medical Products Administration (NMPA) and the FDA for its therapeutic cancer vaccine WGc-043 to enter first-in-human trials.
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Conceptual image for brain cancer treatment

Servier’s glioma treatment approved by FDA

Aug. 7, 2024
By Lee Landenberger
In December 2020, Servier Pharmaceuticals LLC bought Agios Pharmaceuticals Inc.’s approved acute myeloid leukemia drug, Tibsovo (ivosidenib), and the rest of its oncology business in a deal valued at up to $2 billion. Now, the U.S. FDA has approved one of those assets, with the brand name Voranigo (vorasidenib), for treating gliomas.
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Pressure building for bipartisan 340B reforms

Aug. 7, 2024
By Mari Serebrov
With time running out on the 118th U.S. Congress, a group of lawmakers is urging the leadership of the House Energy and Commerce Committee to consider a bipartisan path forward on strengthening the 340B drug discount program.
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Laptop displaying FDA logo

US FDA’s health equity discussion paper suggests more up-front work

Aug. 7, 2024
By Mark McCarty
The U.S. FDA’s discussion paper for health equity for medical devices reiterates standing policy on clinical trial enrollment, such as that the device’s pivotal study should be reflective of the intended use population.
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