October 25, 2024 - 🧬 [nGram] Your Weekly Business Development Insights (18th Oct - 24th Oct): BioNTech-OncoC4 Trial Hold, Novo & Ionis CHMP Nods, Novartis' Kisqali® Approval


  1. FDA imposes partial hold on BioNTech-OncoC4's Phase III trial for Non-Small Cell Lung Cancer due to varying patient results.
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  2. LaNova Medicines initiates Phase 1 trial for LM-299, an anti-PD-1/VEGF bispecific antibody, and completes $42M Series C1 financing to advance its oncology pipeline.
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  3. George Medicines' GMRx2 triple combination pill shows superior efficacy and safety in Phase III trial for Hypertension, published in The Lancet.
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  4. Nurix Therapeutics' BTK degrader NX-5948 shows 77.8% response rate in Phase 1 trial for relapsed/refractory Waldenstrom’s Macroglobulinemia.
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  5. Can-Fite's Piclidenoson shows significant efficacy in canine Osteoarthritis study, leading to a $325M licensing deal with Vetbiolix.
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  6. EMA's CHMP recommends Novo Nordisk's hemophilia therapy and Ionis-AstraZeneca's TTR therapy for approval.
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  7. Supernus Pharmaceuticals' SPN-820 shows rapid improvement in Major Depressive Disorder in Phase 2a trial, with plans for Phase 2b data in Treatment-Resistant Depression next year.
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  8. Cofactor Genomics' OncoPrism receives Medicare coverage for predicting immunotherapy response in head and neck squamous cell carcinoma.
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  9. Novartis' Kisqali receives positive CHMP opinion for reducing recurrence risk in HR+/HER2- early breast cancer.
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  10. FDA approves BOTOX® Cosmetic for temporary improvement of moderate to severe platysma bands, expanding its aesthetic indications.
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  11. Accord Healthcare's ustekinumab biosimilar, Imuldosa®, receives positive CHMP opinion for immunology conditions.
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  12. Roche's VENTANA CLDN18 RxDx Assay receives FDA approval as the first companion diagnostic for gastric and gastroesophageal junction cancer, enabling targeted treatment with VYLOY.
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  13. FibroBiologics partners with Charles River to manufacture fibroblast cell therapies for Diabetic Foot Ulcer clinical trial in 2025.
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  14. ITM and NTP renew technology license and sign a new agreement to boost global production of Lutetium-177 for cancer treatment.
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  15. Legacy and Posterity Health partner to enhance access to male fertility care through a hybrid model offering at-home testing and telehealth services.
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  16. US Heart & Vascular partners with Birmingham Heart Clinic to enhance cardiovascular care in Alabama.
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  17. REGiMMUNE and Kiji Therapeutics merge to form a leading Treg biotech, planning IPO by 2025.
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  18. Advanced Care Group expands nationwide by acquiring 3D Medical Staffing and integrating AI-powered recruiting solutions.
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  19. Avantor completes $650 million divestiture of its clinical services business to Audax Private Equity, focusing on strategic growth in lab and production sectors.
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  20. Audax Private Equity acquires Avantor's clinical services, rebrands as Resonant Clinical Solutions to enhance clinical trial services.
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  21. KdT Ventures secures over $100M for life sciences investments; Terray raises $120M in Series B funding.
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  22. Bright Minds Biosciences announces a US$35 million private placement to fund neurological and psychiatric drug development.
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  23. ARTHEx Biotech doses first patient in Phase I-IIa trial of ATX-01 for Myotonic Dystrophy Type 1, a novel anti-microRNA therapeutic.
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  24. Inventiva secures €348M for late-stage lanifibranor trials in Metabolic Dysfunction-Associated Steatohepatitis.
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  25. KFSHRC leads in cancer treatment with CAR-T cell therapy and CRISPR, achieving a 90% recovery rate for leukemia.
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