Regulatory snapshots, including global drug submissions and approvals, and other regulatory decisions and designations: Biogen, Cogent, Eisai, GSK, Mannkind, Merz.
Biopharma happenings, including deals and partnerships, and other news in brief: Arcutis, Bluejay, BNC Korea, Eclipse, Hanchorbio, Indivior, Kowa, Leios, Mirum, Terrain, Wuxi.
Although the American Academy of Pediatrics has been releasing guidances on vaccines for decades, the 2026 immunization schedule it issued Jan. 26 is creating some buzz given the U.S. CDC’s newly abbreviated childhood schedule that removed several routine recommendations.
Full-year biopharma deal value in 2025 reached $292.55 billion, the highest annual total in BioWorld’s records, following $78.93 billion in the fourth quarter (Q4). The annual total is a 27% increase from the $230.53 billion recorded in 2024.
Suzhou Alphamab Co. Ltd.’s HER2 bispecific antibody, anbenitamab (KN-026), combined with chemotherapy has the potential to become a new standard of care for patients with HER2-positive gastric cancer who failed at least one prior line of therapy, according to newly released phase III results that show the combo cut disease progression risk by 75%.
After a “brutal” year, there is reason for optimism, with the fourth quarter seeing an upswing in deal numbers and the amount raised, according to the UK Bioindustry Association’s final tally of biotech financing in 2025.
Following a clinical hold last October of Intellia Therapeutics Inc.’s Magnitude and Magnitude-2 phase III trials of CRISPR/Cas9 gene editing therapy nexiguran ziclumeran (nex-z) to treat transthyretin amyloidosis with cardiomyopathy (ATTR-CM) and polyneuropathy (ATTR-PN), respectively, the U.S. FDA lifted the hold on Magnitude-2, pushing the company’s shares up by 22% in early trading Jan. 27.
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