October 22, 2024 - 🧬 [nGram] Your Weekly Business Development Insights (15th Oct - 21st Oct): FDA Approvals & Key Clinical Trials


  1. ARTHEx Biotech doses first patient in Phase I-IIa trial of ATX-01 for Myotonic Dystrophy Type 1, targeting microRNA 23b.
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  2. Nurix Therapeutics' BTK degrader NX-5948 shows 77.8% response rate in Phase 1 trial for Waldenstrom’s Macroglobulinemia.
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  3. Nektar's NKTR-255 combined with CAR-T therapy shows doubled 12-month relapse-free survival in B-cell Acute Lymphoblastic Leukemia patients.
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  4. Teleflex's Barrigel™ rectal spacer shows safety and efficacy in reducing rectal radiation exposure during Prostate Cancer therapy, as presented at ASTRO 2024.
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  5. Noema Pharma's NOE-105 (gemlapodect) meets all endpoints in Phase 2a trial for Tourette Syndrome, showing significant tic reduction and no serious adverse events.
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  6. Factor Bioscience and Eterna Therapeutics partner to advance cell therapies for Oncology, Autoimmune, and Rare Diseases.
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  7. PatchRx and Optimize Health partner to enhance remote monitoring for chronic conditions, improving medication adherence and reducing healthcare costs.
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  8. Tonix Pharmaceuticals receives initial payment from U.S. Department of Defense for $34 million contract to develop broad-spectrum antivirals.
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  9. Sanofi and Orano Med partner to develop next-generation radioligand therapies for rare cancers using lead-212 isotopes.
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  10. Novocure's Tumor Treating Fields receives FDA approval for metastatic Non-Small Cell Lung Cancer, marking a significant survival improvement.
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  11. Valneva and LimmaTech's tetravalent Shigella vaccine candidate receives FDA Fast Track designation to expedite development for Shigellosis.
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  12. Theriva Biologics' VCN-01 receives orphan medicinal product designation from the European Commission for Retinoblastoma treatment.
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  13. FDA approves Astellas' VYLOY™ (zolbetuximab-clzb) for first-line treatment of advanced gastric and gastroesophageal junction adenocarcinoma with CLDN18.2-positive tumors.
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  14. Glaukos' Epioxa achieves primary efficacy endpoint in Phase 3 trial for Keratoconus, supporting upcoming FDA submission.
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  15. Merck's CAPVAXIVE™ shows strong immune response in Phase 3 trial for adults at risk of Pneumococcal Disease.
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  16. Rosalind Franklin University receives $100,000 grant to study molecular mechanisms in metastatic Breast Neoplasms.
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  17. Monopar files a provisional patent for new radiopharmaceutical linkers, enhancing stability and biodistribution for cancer treatment.
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  18. The Michael J. Fox Foundation launches LITE to accelerate LRRK2-targeted therapies and biomarkers for Parkinson's Disease.
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  19. Terray Therapeutics secures $120M in Series B funding to advance AI-driven small molecule drug development and immunology programs.
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  20. SONIRE's HIFU therapy system receives FDA Breakthrough Device designation for Pancreatic Neoplasms treatment.
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  21. The National Kidney Foundation invests in Revalia Bio to advance personalized therapies for Chronic Kidney Disease using human organ data.
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  22. OmniaBio opens Canada's largest cell and gene therapy manufacturing facility, enhancing access to advanced treatments and employing AI for efficiency.
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  23. AscellaHealth acquires CHAPPER healthcare to expand global specialty pharmaceutical distribution and enhance market access.
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  24. Kexing Biopharm launches Apexelsin® in the EU market at CPHI Milan 2024, marking a significant step in its global anti-cancer strategy.
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  25. Nurix Therapeutics appoints Anil Kapur to its board, enhancing commercialization strategy for NX-5948 in B-cell malignancies.
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