Two phase III studies of setrusumab, Orbit and Cosmic, for treating brittle bones have failed and left the developers floundering on Wall Street. Neither of Ultragenyx Pharmaceutical Inc. and Mereo Biopharma Group plc’s studies of the monoclonal antibody in treating osteogenesis imperfecta hit statistical significance in their primary endpoints, though they did achieve their secondary endpoints. The companies are still looking at the numbers to determine their next steps. Read More
The strategy of taking aim at IL-4Ra (type I and II receptors) and IL-31 by way of a bispecific antibody in atopic dermatitis (AD) has not worked out as well as Johnson & Johnson (J&J) hoped when, last May, the firm paid $1.25 billion to bring the product aboard by acquiring Yellow Jersey Therapeutics, a wholly owned subsidiary of Numab Therapeutics AG. Read More
China’s National Medical Products Administration approved Innovent Biologics Inc.’s NDA for Tabosun (ipilimumab N01, IBI-310) in combination with sintilimab as neoadjuvant treatment for stage IIB-III resectable microsatellite instability-high or mismatch repair deficient colon cancer. Read More
U.S. policy, China’s strategic rise, blockbuster deals and AI dominated South Korea’s biotechnology industry this year, with U.S. tariffs and the Biosecure Act’s hitch onto 2026 legislation serving as major topics of speculation. Read More
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. Read More
BioWorld logged 170 clinical trial updates across phases I through III in November 2025, a decline from 252 updates in October and 230 in September, but higher than the 95 reported in August. Read More
Regulatory snapshots, including global drug submissions and approvals, and other regulatory decisions and designations: Agios, Omeros, Sanofi and SN Bioscience. Read More
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