Astrazeneca plc is investing $15 billion in China through 2030 to expand R&D and manufacturing, marking one of the largest long-term investments by a multinational pharma company in the country. The U.K.-based company also struck a deal worth up to $3.5 billion with China’s CSPC Pharmaceuticals Group Ltd. to accelerate the development of next-generation therapies for obesity and type 2 diabetes.
Liver fibrosis in the course of metabolic dysfunction-associated steatohepatitis (MASH) could be significantly reduced using CAR T-cells generated in vivo. Scientists at the Icahn School of Medicine at Mount Sinai have developed an experimental cell therapy that eliminates only one type of liver cell, the stellate cells that express fibroblast activation protein alpha (FAP). This strategy not only reduced fibrosis but also reversed liver damage.
Early data of Waldenström’s non-Hodgkin lymphoma patients enrolled in a trial testing Immunitybio Inc.’s off-the-shelf allogeneic CD19 chimeric antigen receptor natural killer cell therapy (CAR-NK), used in combination with anti-CD20 drug rituximab, led to durable complete responses without lymphodepletion.
CAR T cells have made headlines for their ability to fight hematological cancers, but they have proven largely ineffective against solid tumors. To fight such tumors, many groups have engineered T cells to carry T-cell receptors (TCRs) that target cancer antigens, but this approach requires using T cells taken from the patient and it is ineffective against parts of the tumor that have lost expression of the target antigen. As an alternative strategy, researchers at Zelluna ASA in Norway have engineered natural killer (NK) cells to express TCRs against solid tumor antigens.
There was an upbeat message for cell and gene therapy companies in the 2026 industry update presented as the J.P. Morgan Healthcare Conference opened on Monday, with Tim Hunt, CEO of the Alliance for Regenerative Medicine, telling delegates that after lean years of learning, adapting and setbacks, the sector is now self-sustaining.
A second complete response letter issued by the U.S. FDA for Atara Biotherapeutics Inc.’s allogeneic T-cell immunotherapy Ebvallo (tabelecleucel) for Epstein-Barr virus positive post-transplant lymphoproliferative disease is “a complete reversal of position” by the agency, which had previously confirmed the single arm Allele trial was enough to support a BLA under the accelerated approval pathway, the company said.
Moving away from a one-size-fits-all approach, the U.S. FDA's CBER released details Jan. 11 about how it’s leveraging its growing experience with cell and gene therapies (CGTs) to exercise greater regulatory flexibility in chemical, manufacturing and control requirements for the products.
A2 Biotherapeutics Inc. has gained IND clearance from the FDA for A2B-543 for the treatment of germline heterozygous HLA-A*02 adults with recurrent unresectable, locally advanced or metastatic solid tumors.
Ernexa Therapeutics Inc. has successfully completed a pre-IND meeting with the FDA, setting a pathway toward submitting an IND and initiating a first-in-human trial for the treatment of ovarian cancer, expected in the second half of this year.
Abbvie Inc. signed a $1.1 billion New Year’s Eve deal with China’s Zelgen Biopharmaceuticals Co. Ltd., gaining ex-China rights to Zelgen’s lead oncology asset, alveltamig (ZG-006), a trispecific T-cell engager targeting delta-like ligand 3. Under terms of the deal, Abbvie will pay Zelgen an up-front fee of $100 million, and Zelgen is eligible to receive $60 million in near-term milestones and could receive up to $1.075 billion in additional development, regulatory and commercial milestones, alongside tiered royalties on net sales outside China. Zelgen retains full rights in China.
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