December 24, 2024 - 🧬 [nGram] Your Weekly Business Development Insights (17th Dec - 23rd Dec): FDA Approvals & Major Acquisitions


  1. IRX4204 shows promise in repairing myelin and restoring function in Multiple Sclerosis model.
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  2. FDA accepts Arbor's IND for ABO-101, a gene editing therapy for Primary Hyperoxaluria Type 1.
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  3. OraSure Technologies acquires Sherlock Biosciences to enhance rapid STI diagnostics with molecular self-tests.
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  4. Silexion partners with Evonik to develop advanced siRNA formulation for KRAS-driven cancers.
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  5. ExeGi Pharma's EXE-346 shows safety and reduces stool frequency in Phase 1b trial for ileal pouch-anal anastomosis patients.
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  6. TAE Life Sciences and CNAO partner to advance Boron Neutron Capture Therapy for metastatic cancers.
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  7. HKBU's aptamer for X-linked Hypophosphatemia receives Orphan Drug and Rare Pediatric Disease Designations from U.S. FDA.
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  8. Fierce Biotech highlights top 2024 trends, including ADC deals, cell therapy shifts, and biotech bankruptcies.
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  9. ÅŒURA secures $200M in Series D funding to expand smart ring offerings and global presence.
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  10. Actuate Therapeutics reports positive Phase 2 results for elraglusib in metastatic pancreatic cancer, showing improved survival rates.
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  11. EMA validates Cytokinetics' application for aficamten to treat obstructive Hypertrophic Cardiomyopathy.
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  12. EYLEA HD meets Phase 3 trial endpoint, improving vision with extended dosing for Macular Edema following Retinal Vein Occlusion.
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  13. FDA grants Priority Review to Nuvation Bio's taletrectinib for advanced ROS1-positive Non-Small Cell Lung Cancer.
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  14. Kynexis reports positive Phase 1 results for KYN-5356, targeting Cognitive Impairment in Schizophrenia.
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  15. FDA approves first generic GLP-1 injection for Type 2 Diabetes, enhancing patient access and affordability.
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  16. Orexo partners with Abera to develop nasal powder vaccines using AmorphOX technology for enhanced stability and efficacy.
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  17. Teva and Sanofi's Duvakitug shows promising Phase 2b results for Ulcerative Colitis and Crohn's Disease, advancing to Phase 3 trials.
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  18. FDA approves GEMTESA for Overactive Bladder in men with Benign Prostatic Hyperplasia.
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  19. FDA approves Ensartinib for ALK-positive metastatic Non-Small Cell Lung Cancer, offering a new first-line treatment option.
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  20. Assembly Bio secures $30.1M from Gilead to advance Hepatitis D virus candidate ABI-6250 development.
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  21. Novo Holdings completes $16.5 billion acquisition of Catalent, enhancing pharmaceutical development and supply capabilities.
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  22. Terray partners with Gilead to leverage AI for small molecule drug discovery using the tNova platform.
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  23. Ultragenyx doses first patient in Phase 3 trial of GTX-102 for Angelman Syndrome.
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  24. CD40 targeted therapies expected to gain first approval by 2027, with over 20 therapies in clinical trials.
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  25. Gene-edited pig kidney transplant offers new hope for end-stage kidney disease patients.
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