Entvin AI Secures $500K from Y Combinator to Transform FDA Drug Approval Process
• Entvin AI, founded by three IIT Bombay graduates, has raised $500K from Y Combinator to streamline the complex FDA drug approval process through specialized AI solutions.
• The company's AI platform automates regulatory documentation, compliance verification, and monitoring tasks, with early users reporting hundreds of hours saved in manual regulatory work.
• Entvin AI aims to accelerate pharmaceutical development timelines and reduce compliance costs in a multi-billion-dollar market, addressing critical inefficiencies that delay life-saving treatments.
U.S. Gene Therapy Market Projected to Reach $22.23 Billion by 2034, Growing at 19.8% CAGR
• The U.S. gene therapy market is expected to grow from $4.37 billion in 2025 to $22.23 billion by 2034, driven by increasing investments, rising prevalence of chronic diseases, and integration of advanced technologies.
• Gene silencing has emerged as the dominant segment in the market, while oncology applications currently lead but neurology treatments are anticipated to gain significant market share in the coming decade.
• Artificial intelligence is revolutionizing gene therapy development by analyzing genomic data, identifying therapeutic targets, enabling personalized treatment strategies, and optimizing manufacturing processes to reduce costs.
Immuneel Launches Qartemi, a CAR T-cell Therapy for Non-Hodgkin's Lymphoma in India
• Immuneel Therapeutics has launched Qartemi, India's first CAR T-cell therapy for treating adult B-cell Non-Hodgkin Lymphoma (B-NHL).
• Qartemi is a personalized therapy that modifies a patient’s T-cells to target and eliminate cancer cells, offering hope for lasting remission.
• Clinical trials in India and Spain demonstrated that Qartemi's safety and efficacy are similar to US FDA-approved CAR T-cell therapies.
• Priced at approximately ₹35 to ₹50 lakh, Qartemi is significantly more affordable than similar treatments in the US.
India's Indigenous CAR T-Cell Therapy Revolutionizes Cancer Treatment at One-Tenth Global Cost
• India has successfully developed NexCAR19, its first indigenous CAR T-cell therapy for blood cancers, priced at approximately Rs 40 lakh ($50,000) compared to $400,000 in the United States.
• Clinical trials involving 64 patients with advanced lymphoma or leukemia showed promising results, with 67% experiencing significant cancer reduction and about half achieving complete remission.
• Unlike U.S. approved therapies that use mouse-derived antibody fragments, India's "humanized" CAR T-cells caused fewer severe side effects, with no reported neurologic complications and only 5% experiencing severe cytokine release syndrome.
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