December 17, 2024 - 🧬 [nGram] Your Weekly Business Development Insights (10th Dec - 16th Dec): FDA Approvals & Breakthroughs in Cancer & Diabetes


  1. Intensity Therapeutics presents promising Phase 2 data for INT230-6 in Triple Negative Breast Cancer at SABCS 2024.
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  2. FDA approves Crenessity for Congenital Adrenal Hyperplasia, reducing glucocorticoid dose in adults and children.
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  3. MannKind's Afrezza shows non-inferiority to injections in Phase 3 trial for Pediatric Diabetes.
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  4. HUTCHMED's ORPATHYS® and TAGRISSO® combo receives Breakthrough Therapy Designation in China for EGFR mutation-positive NSCLC with MET amplification.
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  5. Sinovac begins Phase III trial for bivalent vaccine against Hand, Foot, and Mouth Disease in children.
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  6. SK Biopharmaceuticals partners with ProEn Therapeutics to develop radiopharmaceuticals for oncology by 2027.
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  7. FDA grants Breakthrough Device Designation to MeMed Severity test for suspected Sepsis management.
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  8. Agendia's MammaPrint and BluePrint predict chemotherapy response and CDK4/6 resistance in early-stage Breast Neoplasms.
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  9. Jazz Pharmaceuticals announces CEO Bruce Cozadd's retirement plan, with a successor search to conclude by 2025.
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  10. Global hematology market projected to grow at 8% CAGR by 2030, driven by blood disorder prevalence and technological advancements.
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  11. Vir Biotechnology's tobevibart and elebsiran receive FDA and EMA designations for Chronic Hepatitis Delta treatment.
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  12. Promise Bio secures $8.3M to advance precision medicine for immune-mediated diseases using AI and epiproteomics.
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  13. Merck discontinues vibostolimab and favezelimab trials for Non-Small Cell Lung Cancer and Hodgkin Lymphoma due to futility.
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  14. Bio-Thera Solutions expands LATAM partnership with SteinCares, adding a third biosimilar for distribution in Brazil and LATAM.
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  15. FDA approves CRENESSITY for Classic Congenital Adrenal Hyperplasia, offering a new treatment option after 70 years.
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  16. Bausch + Lomb acquires Elios Vision, enhancing minimally invasive glaucoma surgery capabilities with ELIOS laser technology.
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  17. Candid Therapeutics announces three new collaborations to develop T-cell engager antibodies for autoimmune diseases.
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  18. FDA approves Crenessity for Congenital Adrenal Hyperplasia, reducing glucocorticoid dose in adults and children.
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  19. Merus doses first patient in Phase 2 trial of petosemtamab for metastatic colorectal cancer.
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  20. GXP-Storage receives investment from Whistler Capital to expand biorepository and regulated material management services.
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  21. Contineum Therapeutics begins Phase 1b trial of PIPE-791 for Idiopathic Pulmonary Fibrosis and Progressive Multiple Sclerosis.
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  22. Menarini's Obicetrapib shows significant LDL-C reduction in Phase 3 trials for Atherosclerotic Cardiovascular Disease and Familial Hypercholesterolemia.
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  23. Adcendo exercises option to use Biocytogen's antibodies, advancing ADC development for cancer treatment.
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  24. Immutep reveals LAG-3 binding mechanism to MHC Class II, advancing cancer and autoimmune therapy development.
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  25. FDA approves VTAMA cream for Atopic Dermatitis in patients aged 2 and older.
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