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.
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.
In October, the Nobel Committee awarded the 2025 Nobel Prize in Physiology or Medicine to Shimon Sakaguchi, Mary Brunkow and Fred Ramsdell for their discoveries in the field of autoimmunity. As has become typical for the scientific Nobel Prizes, the award-winning research is by now several decades old. But the discoveries were the basis for ongoing research into how to prevent autoimmunity that notched significant wins in 2025, in both basic research and in the clinic.
Secondary lymphedema is a chronic condition that often affects the upper or lower extremities and is characterized by progressive retention of lymphatic fluid at affected sites. At the affected sites, this progressive fluid retention often leads to pain, decreased function and wounds. The condition is commonly associated with cancer surgery that requires the removal of draining lymph nodes.
In October, the Nobel Committee awarded the 2025 Nobel Prize in Physiology or Medicine to Shimon Sakaguchi, Mary Brunkow and Fred Ramsdell for their discoveries in the field of autoimmunity. As has become typical for the scientific Nobel Prizes, the award-winning research is by now several decades old. But the discoveries were the basis for ongoing research into how to prevent autoimmunity that notched significant wins in 2025, in both basic research and in the clinic.
Zelluna ASA has submitted a clinical trial application (CTA) to the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) for ZI-MA4-1 (ZIMA-101), the company’s lead candidate. ZI-MA4-1 is a novel MAGE-A4-targeting T-cell receptor-natural killer (TCR-NK) therapy.
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