Regulatory snapshots for biopharma and med tech, including global submissions and approvals, and other regulatory decisions and designations: Alvotech, Artiva, Intrabio, Oncolys, Pfizer, Sanofi, Vcare, Vor, Remegen, Xspray.
Biopharma and med-tech happenings, including deals and partnerships, and other news in brief: Aclarion, Ayumi, Colospan, Corxel, Everest, Galmed, GNI, Karo, Lenz, Moberg, Novo Nordisk, Raymond, Sangamo, Senseonics, Takeda, Teva.
China’s National Medical Products Administration (NMPA) on June 4 granted conditional approvals to two oncology drugs from Lupeng Pharmaceutical Co. Ltd. and Vcare Pharmatech Co. Ltd., as well as one hemophilia drug developed by Staidson Biopharmaceutical Co. Ltd.
Japan has granted marketing approval to Oncolys Biopharma Inc.’s oncolytic adenovirus product, Telomelysin (suratadenoturev, OBP-301), for treating esophageal cancer in patients who are not eligible for curative resection or chemoradiotherapy. The approval marks the first oncolytic adenovirus product approved for esophageal cancer.
Wuxi Apptec isn’t going down without a fight after the U.S. Department of Defense added it to the Section 1260H list June 8 as a designated “Chinese military company,” which makes it a “biotechnology company of concern” under the Biosecure Act. “Such designation is mistaken and baseless,” the global contract research, development and manufacturing organization said in an open letter to its life sciences partners. “We will pursue every available avenue to correct this mistake.” That includes appealing the designation.
Total med-tech financing through the first five months of 2026 reached $11.01 billion, falling between 2024’s $12.76 billion and 2023’s $8.95 billion over the same period, and trailing 2025’s $14.83 billion.
Scientists at Columbia University have used base editing to make precise changes in the genomes of human embryos, avoiding the damage to chromosomes that occurs following two-stranded DNA cuts with conventional Crispr-Cas9 editing.
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