Wall Street breathed easier, and shares of Abivax SA found relief as further phase III data from the Abtect maintenance trial were disclosed with obefazimod in ulcerative colitis (UC).
The U.S. FDA’s new Precheck Pilot Program is taking flight with seven biopharma companies on board. As part of the Trump administration’s efforts to encourage onshoring of biopharma manufacturing, the program is intended to increase regulatory predictability, facilitate the construction of U.S. manufacturing sites and streamline the FDA’s plant assessments in advance of a specific product application.
AI, data and wearable technologies are transforming health care, giving patients greater access to information about their health and enabling faster, more responsive clinical trials, Anthony Costello, CEO of Medidata Solutions Inc., told BioWorld. As more people use wearable devices to monitor their health, they are increasingly able to react to those insights, while pharmaceutical companies are gaining a clearer picture how patients respond to treatments during clinical trials.
The academic authors of the paper describing the pivotal trial of Amgen Inc.’s Tavneos (avacopan) have retracted it from The New England Journal of Medicine because the primary endpoint assessments of nine patients were “re-adjudicated” after the database was locked and the study unblinded.
Deep brain stimulation (DBS) through implanted electrodes has enabled fundamentally new ways of treating certain disorders. More than 100,000 severely ill patients have received an implant to treat Parkinson’s disease, which is DBS’ greatest success story.
A U.S. biotechnology company founded by Deerfield Management Company L.P. licensed exclusive rights to Metis Techbio Co. Ltd.’s preclinical trispecific T-cell engager (TCE) for autoimmune disorders in a potential $1.62 billion deal.
Awards are an honor, but they are not why we do what we do. That's why this year's recognition from the APEX Awards is especially meaningful. BioWorld earned seven 2026 APEX Awards, including three Grand Awards and four Awards of Excellence. Judged by publishing industry peers, these honors recognize excellence across reporting, writing, visual storytelling and editorial collaboration. While we are proud of this recognition, what makes it especially rewarding is that it reflects the work our team does every day to serve the global life sciences community.
Regulatory snapshots for biopharma and med tech, including global submissions and approvals, and other regulatory decisions and designations: Acadia, Amgen, Arbor, Astrazeneca, Daiichi, Eli Lilly, Everest, Incyte, Johnson, Maat, Omeros, Pharmaessentia, Replimune, Xspray.
Biopharma and med-tech happenings, including deals and partnerships, and other news in brief: CSL Seqirus, Elixirgen, Incyte, Ipsen, Kartos, Larimar, Nippon, Sanofi, SNT, Waters.
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