On November 8, 2024, the U.S. FDA issued a historic approval of the seventh CAR-T cell therapy to be approved in the U.S. and the 11th CAR-T therapy to be approved globally. This approval was for Autolus Inc.’s Aucatzyl (obecabtagene autoleucel), a CD19-directed genetically modified autologous T cell immunotherapy, for adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL). Autolus is a U.K. biotech company that develops novel gene-modified T cell therapies for the treatment of cancer. [Read more…]
Is the CAR-T Cell Therapy Craze Driving Pharma Investment?
Without a doubt, the cell therapy industry is coming of age. In addition to growing numbers of cell therapy clinical trials, numerous cell therapy products have been approved by regulatory agencies worldwide and 150+ cell therapy companies are competing within the global marketplace. These metrics are extremely important because they indicate that the market for cell therapy products is expanding.
However, one of the most telling trends within the industry is a growing interest among Big Pharma in cell therapy companies. [Read more…]
Fiocruz and Caring Cross To Offer Drastically More Affordable CAR-T Therapy in Brazil and Latin America
Local production will permit CAR-T treatment to be available free of charge to patients.
The cost to the Brazilian public health system will be slashed to 10% of the amount currently charged in Europe and the USA (only US$35,000 per dose).
RIO DE JANEIRO and GAITHERSBURG, Md., March 26, 2024 — Fundação Oswaldo Cruz (Fiocruz), a foundation from the Brazilian government’s Ministry of Health, and Caring Cross, a 501(c)(3) non-profit dedicated to accelerating the development of advanced medicines and enabling access to advanced medicinal cures for all patients, everywhere, today announced a collaboration to develop local manufacturing of chimeric antigen receptor (CAR)-T cell and stem cell gene therapies for oncology, infectious, and genetic diseases in Brazil, including CAR-T cell therapies for leukemia, lymphoma, and HIV infection. [Read more…]
Cellipont Bioservices and Wugen Sign Agreement for the Clinical Manufacture of Wugen’s Off-the-shelf CAR-T Cellular Therapies
The Woodlands, TX, and St. Louis, MO, March 14, 2024 – Cellipont Bioservices, a leading cell therapy Contract Development and Manufacturing Organization (CDMO), and Wugen, Inc., a clinical-stage biotechnology company developing allogeneic, off-the-shelf cell therapies to treat a broad range of hematological and solid tumor malignancies, today announced the signing of an agreement for the manufacturing of their CAR-T cell therapies. [Read more…]
Celularity – Big Bucks, Billionaire Investors, Bold Dreams
Celularity is a biotechnology company that specializes in leveraging biologically active cell populations within the postpartum human placenta. Founded on the pioneering work of Robert Hariri, MD, PhD, in human placenta-derived cellular therapeutics and biomaterials, Celularity is uniquely positioned to harness the potential of most biocreative event on earth: human birth. [Read more…]
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