Ready or not, the future has arrived. Novel AI and brain-computer interface (BCI) systems are no longer confined to the realm of science fiction. As an increasingly intertwined human-machine model moves closer to adoption in real-world clinical and military practice, technological advances are sparking concerns over public health, ethics and national security. Read More
With the U.S. FDA go-ahead granted June 26 for Viridian Therapeutics Inc.’s IGF-1R antagonist Lumvoa (veligrotug-vvze, or “veli”) as a new thyroid eye disease (TED) therapy – due to launch immediately, the company said – Wall Street will be watching near-term payer dynamics. The drug is set to take on similarly targeted Tepezza (teprotumumab-trbw), owned by Amgen Inc. and approved in January 2020 to treat TED. Read More
One company was looking to add to its royalty stream and R&D portfolio. The other was seeking strategic alternatives in the wake of clinical misfires over the last few years. In an agreement aimed at satisfying both goals, Zymeworks Inc. will acquire Theravance Biopharma Inc., paying $17 per share, or about $929 million, though the transaction is structured in a way that minimizes the former’s current capital position. Read More
Following an initial rebuff in February 2026, the EMA’s Committee for Medicinal Products for Human Use (CHMP) is recommending approval of Acadia Pharmaceuticals Inc.’s Daybu (trofinetide) for treating neurobehavioral symptoms of Rett syndrome, after it took another look at the file. Read More
The gut microbiota may be altered in people with depression as a result of treatment. These microorganisms reorganize differently in individuals who respond to therapy. In a multiomics study of antidepressant-naive patients presented at the 2026 World Congress of Neuropsychopharmacology (CINP), scientists from National Taiwan University found that patients who improved after antidepressant treatment maintained a more balanced and functional microbial ecosystem, recovered beneficial metabolites, and displayed blood-based biological signals that aligned with these changes. Read More
Roche Holding AG is looking to take a share of Illumina Inc.’s dominance in the gene sequencing market with the launch of Axelios 1, its next-generation sequencing (NGS) platform designed for accuracy, speed, flexibility, scalability and cost efficiency. The move signals a potential shift in the sequencing landscape as the technology aims to address critical bottlenecks in genomics. Read More
Samsung Bioepis Co. Ltd. announced positive top-line phase I and phase III data for SB-27, a proposed biosimilar to Merck & Co. Inc.’s blockbuster immunotherapy Keytruda (pembrolizumab). Preliminary analysis of parallel-run global phase I and phase III studies demonstrated SB-27’s clinical and pharmacokinetic (PK) equivalence to the reference product, according to a company announcement. Read More
While the U.S. Supreme Court made it clear earlier this month in Hikma v. Amarin that skinny labels are still on the board for generics, the court didn’t resolve all disagreements over the generic carveouts. Read More
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. Read More
Biopharma and med-tech companies raising money in public or private financings, including: Definium, Idorsia, Imagion, Ligand, Nuvation, Proqr, Uniqure. Read More
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. Read More
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. Read More
