FDA approves Novocure’s innovative HFE transducer arrays for use with Optune Gio for glioblastoma
- The FDA has approved Novocure's new Head Flexible Electrode (HFE) transducer arrays for use with Optune Gio in treating glioblastoma multiforme (GBM).
- These new arrays are lighter and thinner, utilizing a flexible polymer material instead of ceramic discs, enhancing patient comfort.
- Optune Gio is a wearable device that uses Tumor Treating Fields (TTFields) to disrupt cancer cell division.
- Novocure plans to transition U.S. Optune Gio users to the new HFE arrays by mid-2025.
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Zevra Therapeutics announces U.S. commercial availability of MIPLYFFA for Niemann-Pick disease type C
- MIPLYFFA, the first FDA-approved treatment for Niemann-Pick disease type C, is now available in the U.S.
- The drug is indicated for use with miglustat to treat neurological symptoms in patients aged 2 and older.
- Zevra's AmplifyAssist program supports patients with insurance, copay assistance, and therapy management.
- MIPLYFFA was granted multiple designations by the FDA, including Breakthrough Therapy and Orphan Drug.
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Amprion announces landmark study in The Lancet Neurology
- Amprion's study in The Lancet Neurology highlights the synuclein seed amplification assay (synSAA) for differentiating synuclein seeds.
- The assay distinguishes between Type 1 seeds (linked to PD, DLB, iRBD) and Type 2 seeds (associated with MSA) based on fluorescence levels.
- Conducted across seven institutions in four countries, the study achieved 100% agreement with the gold standard of pathology.
- Amprion plans to scale and validate synSAA for commercial use, with a clinical launch anticipated in the second half of 2025.
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Amneal resubmits DHE autoinjector NDA and receives FDA approval for exenatide
- Amneal resubmitted its NDA for a DHE autoinjector for treating migraines and cluster headaches.
- The autoinjector offers a single-dose, ready-to-use solution without refrigeration or assembly.
- FDA approval for exenatide, a generic GLP-1 agonist, marks Amneal's first in this category.
- Exenatide is indicated for improving glycemic control in adults with type 2 diabetes.
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Quiver Bioscience publishes study on Fragile X syndrome therapeutic discovery
- Quiver Bioscience's study in Nature Communications Biology highlights their Genomic Positioning System (GPS) platform.
- The platform integrates human neuronal electrophysiology data with AI/ML for drug discovery in Fragile X Syndrome (FXS).
- The study used iPSCs from FXS patients and CRISPR/Cas9 to identify disease-relevant cellular features.
- Quiver aims to use this platform to develop precision therapies for CNS disorders.
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Virpax extends agreement with U.S. Department of Health for NES100 development
- Virpax Pharmaceuticals has extended its cooperative research and development agreement with the National Center for Advancing Translational Sciences (NCATS), part of the NIH.
- The collaboration focuses on NES100, an intranasal peptide for managing acute and chronic non-cancer pain.
- NES100 uses nanotechnology to enhance enkephalin delivery to the brain, potentially offering a non-addictive alternative to opioids.
- The extension supports ongoing pre-clinical and clinical development efforts for NES100.
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