Chemotherapy is often seen solely as a tumor-targeting treatment, yet new evidence reveals a paradox: the tissue injury it causes can reprogram the body’s defenses, influencing the risk of metastasis. Researchers from the University of Lausanne and collaborators reported that chemotherapy reshapes the gut-immune axis by inducing microbiota-derived indole-3-propionic acid, which reprograms myelopoiesis to curb monocyte-driven immunosuppression and metastasis in colorectal cancer.
Regulatory snapshots, including global drug submissions and approvals, and other regulatory decisions and designations: Biogen, Drug Farm, Glaukos, Guerbet, Immix , Johnson & Johnson, Shorla.
The days of the U.S. FDA considering as trade secrets country-of-origin info for drugs and their ingredients have to end, the Senate Aging Committee was told at a Jan. 29 hearing on truth in drug labeling.
Oncology-focused Eikon Therapeutics Inc. set the terms of its IPO Jan. 28, selling 17.648 million shares at a price range between $16 to $18 per share. At the top of the range, the Millbrae, Calif.-based biopharma company would raise about $317.7 million.
For years, Japan’s “drug lag” was shorthand for slow regulatory reviews and delayed approvals compared with the U.S. and Europe. But even as regulatory timelines have shortened, review capacity has expanded and international alignment has improved, Japanese patients still face gaps in access to innovative drugs.
The presbyopia space gained another player as Tenpoint Therapeutics Ltd. won the U.S. FDA’s go-ahead for Yuvezzi (carbachol and brimonidine tartrate ophthalmic solution, 2.75%/0.1%, previously known as Brimochol PF), the first and only dual-agent eye drop for the treatment of adult presbyopia.