October 16, 2024 - 🧬 [nGram] Your Weekly Business Development Insights (9th Oct 24 - 15th Oct 24): FDA Approvals & Major Pharma Collaborations


  1. Immatics reports 54% objective response rate in Phase 1b trial of IMA203 for metastatic melanoma, advancing to Phase 3 trial.
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  2. Immatics advances IMA203 cell therapy to Phase III for Melanoma, targeting progression-free survival as primary endpoint.
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  3. MeiraGTx's gene therapy AAV-GAD shows improved motor function in Phase II trial for Parkinson's Disease.
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  4. Allakos reports Phase 1 trial results showing subcutaneous AK006 is well-tolerated with 77% bioavailability in healthy volunteers.
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  5. Jazz Pharmaceuticals reports significant survival benefits in Phase 3 trial of Zepzelca and atezolizumab for extensive-stage small cell lung cancer.
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  6. FDA approves Roche's Itovebi for advanced hormone receptor-positive, HER2-negative breast cancer with PIK3CA mutation, doubling progression-free survival.
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  7. FDA approves Accord BioPharma's IMULDOSA, a biosimilar to STELARA, for treating chronic inflammatory conditions like Psoriasis and Crohn's Disease.
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  8. FDA approves Pfizer's HYMPAVZIâ„¢ for Hemophilia A and B, offering a once-weekly subcutaneous treatment option without inhibitors.
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  9. Pfizer partners with Triana Biomedicines in a $1.5B deal to develop molecular glue degraders for cancer and other diseases.
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  10. FDA approves Novocure's Optune Lua for metastatic Non-Small Cell Lung Cancer, showing significant survival benefits in Phase 3 LUNAR study.
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  11. Cytosurge and Lexogen partner to enhance live-cell sequencing, integrating FluidFM® and LUTHOR HD for scalable transcriptomics research.
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  12. Boehringer Ingelheim partners with Circle Pharma to develop a novel cyclin inhibitor for hard-to-treat cancers, with potential milestone payments up to $607 million.
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  13. Johnson & Johnson's nipocalimab shows promise in adolescents with Myasthenia Gravis, supporting FDA review for adult use.
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  14. Lantern Pharma's LP-184 receives FDA Fast Track Designation for Glioblastoma, advancing in Phase 1A trials to improve treatment options for this aggressive brain cancer.
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  15. FDA approves Genentech's Itovebi for treating advanced hormone receptor-positive, HER2-negative breast cancer with PIK3CA mutation, doubling progression-free survival.
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  16. Children's Hospital of Philadelphia receives $10 million ARPA-H award to develop a data-sharing tool for Cancer and Rare Diseases research.
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  17. Tencent invests $30 million in Insighta to advance AI-driven early cancer detection technology.
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  18. GEn1E Lifesciences reveals a novel dual signal modulator, GEn-1124, showing promise in treating inflammatory and autoimmune diseases by targeting the p38α:MK2 complex.
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  19. Eli Lilly invests $364M in the UK for its first European Gateway Lab, focusing on obesity and life sciences innovation.
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  20. Tevogen Bio's Phase I trial shows promising results for TVGN 489, an allogeneic T-cell therapy for SARS-CoV-2, with 99% viral elimination by day 14 and no Long COVID development in immunocompromised patients.
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  21. Hoth Therapeutics secures US patent for HT-ALZ, advancing Alzheimer's Disease treatment towards clinical trials.
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  22. Vizgen and Ultivue merge to enhance spatial multi-omics, combining genomics and proteomics technologies for deeper insights into disease mechanisms.
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  23. NEXGEL anticipates record Q3 2024 revenue of $2.85 million, marking a 133% year-over-year increase.
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  24. Madrigal Pharmaceuticals launches Rezdiffra, the first approved drug for Metabolic Dysfunction-Associated Steatohepatitis, with a targeted marketing strategy and plans for European expansion.
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  25. Klotho Neurosciences appoints Shire Pharmaceuticals co-founder Peter Moriarty as COO to advance cell and gene therapies for neurodegenerative diseases like Alzheimer's Disease and Parkinson's Disease.
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