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Makary, Prasad suggest more spokes for bespoke pathway

Nov. 13, 2025
By Mari Serebrov
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In an article that reads like informal guidance, U.S. FDA Commissioner Marty Makary and CBER Director Vinay Prasad discussed the criteria for using the agency’s novel plausible mechanism pathway for personalized treatments when a randomized trial isn’t feasible, as well as future uses of the approval path that could expand beyond gene and cell therapies to other biologics and even small molecules.
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Lyell loves it: ICT phase I mCRC prospect floats license deal

Nov. 10, 2025
By Randy Osborne
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CEO Lynn Seely said Lyell Immunopharma Inc. is going “full steam ahead” with development of rondecabtagene autoleucel (ronde-cel, also known as LYL-314) amid the excitement of the firm’s latest news: the buy of global rights to LYL-273, an autologous guanylyl cyclase-C-targeted CAR T-cell candidate for metastatic colorectal cancer (mCRC), from Innovative Cellular Therapeutics Inc. (ICT) for an up-front payment of $40 million and 1.9 million shares of Lyell common stock.
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Art concept for epigenetic editing

Epigenetic switch and gene editing activate human T cells

Oct. 24, 2025
By Mar de Miguel
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Durable reprogramming of human T cells may now be possible thanks to a new technique based on the CRISPRoff and CRISPRon methodology. Researchers from the Arc Institute, Gladstone Institutes, and the University of California San Francisco have stably silenced or activated genes in this type of immune cell without cutting or altering its DNA, making T cells more resistant, active, and effective against tumors.
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Illustration of human body surrounded by DNA, cell and drug icons
Drug design, drug delivery & technologies

At ESGCT, emerging technologies for in vivo therapies

Oct. 9, 2025
By Mar de Miguel
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The transition from complex and costly ex vivo strategies to platforms that enable direct cellular intervention within the body, known as in vivo therapies, is marking a paradigm change in the field of gene and cell therapies by simplifying manufacturing, improving tissue targeting and expanding clinical access to treatments.
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Microscope on Japan flag

Bio Japan 2025: Nobel Prizes invigorate Japan’s bio industry

Oct. 8, 2025
By Tamra Sami
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Bio Japan 2025 was abuzz with the news that Japan has once again snagged the Nobel Prize in Physiology or Medicine, with Shimon Sakaguchi winning for his discovery of a subtype of CD4-expressing T cells that affect the immune response. Earlier today, Susumu Kitagawa snatched the second Nobel Prize for Japan, this time in chemistry. Both Nobel Prize winners were professors at Kyoto University.
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Red CAR T cell on blue blackground
Drug design, drug delivery & technologies

ESGCT 2025: Redefining CAR T cells across cancer and autoimmunity

Oct. 8, 2025
By Mar de Miguel
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As the many challenges facing cell therapies are being addressed, the CAR T field continues to evolve beyond its original design of T cells engineered to target hematological malignancies. During the 32nd Annual Congress of the European Society of Gene and Cell Therapy (ESGCT), held in Seville Oct. 7-10, several studies showed how this technology is being redefined as programmable and adaptable immune cells with expanded functional versatility.
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Natural killer cell attacking cancer cell

Takeda ditches cell therapy business

Oct. 2, 2025
By Tamra Sami
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Takeda Pharmaceutical Co. Ltd. is exiting all work in cell therapies and will seek an external partner to advance the company’s research and clinic-ready cell therapy programs, the company said, noting that it is not currently running any clinical trials using cell therapy technology.
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