Takeda Pharmaceutical Co. Ltd.’s anti-CD38 antibody, mezagitamab (TAK-079), sustained kidney function up to 18 months after treatment ended in patients with primary immunoglobulin A (IgA) nephropathy, showing early signs of disease modification in a phase Ib study presented at the American Society of Nephrology’s Kidney Week 2025 in Houston.
Biopharma financings from January through October 2025 totaled $61.45 billion, roughly in line with the $61.04 billion raised during the same period in 2023 but down sharply from last year’s $93.83 billion.
Blocking progesterone receptor (PR) activity has long been viewed as a possible approach to breast cancer prevention. Historically, most supporting evidence came from animal models, epidemiological studies or mechanistic pathway analyses. Now, a team at the University of Manchester has uncovered direct mechanistic and clinical evidence that PR antagonists can reprogram the breast tissue microenvironment, suggesting a novel avenue for reducing breast cancer risk in women.
Enara Bio Ltd. is staking a claim to having validated the first in a new class of tumor antigens derived from unannotated regions of the dark genome, describing its findings in talks and posters being presented at the Society of Immunotherapy in Cancer (SITC) meeting in National Harbor, Md., Nov. 5-9, 2025.
Industry watchers were surprised when Eli Lilly and Co.’s oral GLP-1 candidate, orforglipron, did not appear among the first nine recipients of the U.S. FDA’s commissioner’s national priority voucher (CNPV) program aimed at shortening regulatory review times, boosting domestic manufacturing and improving affordability. But orforglipron, which recently nailed endpoints in a second phase III trial and has been hailed a potentially best-in-class compound, was among the second batch of six drugs added to the CNPV list.
Regulatory snapshots, including global drug submissions and approvals, and other regulatory decisions and designations: Averoa, Biohaven, Calico, Forcast, Kwangdong, Leukogene, Tenpoint, Zhaoke.
Biopharma happenings, including deals and partnerships, and other news in brief: Ailux, Atai, Aveo, Beckley, BMS, Dispatch, Eli Lilly, Evotec, Hibercell, Karo, Moberg, Nona, Polyactiva, Raresight, Sandoz, Umoja, Xtalpi.
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