November 26, 2024 - 🧬 [nGram] Your Weekly Business Development Insights (19th Nov - 25th Nov): FDA Approvals & Major Financing in Biopharma


  1. BioNJ members pledge paid time off for employees participating in clinical trials to enhance health equity.
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  2. FDA approves Attruby for reducing cardiovascular death and hospitalization in Transthyretin Amyloid Cardiomyopathy patients.
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  3. Eflornithine and lomustine improve survival in recurrent grade 3 IDH mutant astrocytoma, per Phase 3 STELLAR study.
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  4. Adcendo raises $135M to advance first-in-class ADCs for cancer treatment.
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  5. FDA approves Shorla's IMKELDI, an oral solution for treating Chronic Myeloid Leukemia and other cancers.
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  6. Citius Pharma's FDA meeting outlines NDA pathway for Mino-Lok in treating catheter-related bloodstream infections.
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  7. NIH advances stroke drug development with new clinical platform for preclinical study graduate.
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  8. Pfizer appoints Chris Boshoff as new R&D chief to revitalize oncology and innovation strategy.
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  9. Humacyte to present Phase 3 trial results on bioengineered vessels for End Stage Renal Disease at VEITH Symposium.
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  10. Vaping causes immediate negative effects on vascular function, similar to traditional smoking, even without nicotine.
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  11. Kyowa Kirin invests $330M in Kura's ziftomenib for Acute Myeloid Leukemia, aiming for FDA approval by 2025.
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  12. Boston Scientific to acquire Intera Oncology, enhancing liver cancer treatment with FDA-approved hepatic artery infusion therapy.
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  13. Adcendo raises $135M to advance ADC candidates targeting cancers with high unmet needs, including soft tissue sarcoma.
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  14. FDA approves StemCyte's REGENECYTE™ for hematopoietic stem cell therapy in blood and immune disorders.
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  15. FDA approves Ziihera for HER2-positive Biliary Tract Cancer, marking a milestone for Zymeworks' bispecific antibody technology.
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  16. FDA grants RMAT designation to Intellia's CRISPR therapy for Hereditary Transthyretin Amyloidosis with Polyneuropathy.
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  17. DNA sequencing market to reach $21.3 billion by 2031, driven by clinical applications and genomic projects.
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  18. Scinai's equity rises to $10M after EIB loan conversion; positive psoriasis trial feedback received.
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  19. InxMed's Ifebemtinib gains Breakthrough Therapy status for NSCLC with KRAS G12C mutation in China.
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  20. Alpheus Medical's sonodynamic therapy doubles survival in Phase 1/2 trial for recurrent high-grade gliomas.
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  21. Zai Lab and Pfizer collaborate to commercialize XACDURO® for carbapenem-resistant Acinetobacter baumannii in China.
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  22. EndoTheia's FlexStone Basket completes successful trial, enhancing precision in kidney stone removal.
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  23. Plus Therapeutics' CNSide assay improves diagnosis and management of Leptomeningeal Metastases, showing 2.8x sensitivity over standard cytology.
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  24. Lineage Cell Therapeutics announces $66 million direct offering for cell therapy development.
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  25. Gilead acquires Aelix's HTI vaccine program after promising Phase 2 results for HIV treatment.
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