Demonstrating better tolerability and safety in comparison with standard of care, Edgewise Therapeutics Inc.’s EDG-7500 is moving toward a phase III trial for both obstructive and nonobstructive hypertrophic cardiomyopathy (HCM), the most common form of genetic heart disease. Boulder, Colo.-based Edgewise reported top-line phase II results from part D of the Cirrus-HCM trial, showing meaningful responses in terms of hemodynamics, biomarkers and patient-reported measures. Read More
Moderna Inc. will soon find out if the tumult-ridden U.S. FDA’s switcheroo in mid-February will stick regarding mRNA-1010, a prospective new seasonal influenza vaccine. The Vaccines and Related Biological Products Advisory Committee on June 17 takes up the matter of the shot, which trails a curious history. Read More
The EMA’s 2025 annual report highlights the pressure it is under to streamline and simplify assessment processes, and the expanded – and explicit – role the agency now has in boosting the competitive position of the EU in the development and manufacturing of drugs. Read More
Liability remains one of the biggest barriers to the adoption of AI in healthcare. As more tools get developed for use in clinical settings, a key question persists: Who is ultimately at fault when something goes wrong – the hospital, the clinician or the developer? That uncertainty is making clinicians hesitant to adopt new technologies, delegates heard at the HLTH Europe conference in Amsterdam on June 16. Read More
Dimerix Ltd. has signed an exclusive licensing deal with Everest Medicines Ltd. to commercialize its phase III kidney disease candidate DMX-200 in a transaction worth up to AU$481 million (US$340 million), plus sales royalties. Read More
Clonal hematopoiesis (CH), where few blood stem cells produce a significant fraction of mature blood cells that are genetically identical, is partly an inevitable feature of aging. Certainly, it is near universal in those older than 60. CH is not itself a disease, but 1%-2% of CH cases progress to acute myeloid leukemia, and it raises the risk of some other types of cancer as well. A total of eight genes are responsible for 95% of CH cases, George Vassiliou told the audience in Saturday’s plenary session at the 2026 Annual Congress of the European Hematology Association (EHA 2026). Read More
New hires and promotions in the biopharma and med-tech industries, including: 4basebio, Atara, Bio Usawa, BRC, Conexeu, Fate, Hansa, Immuneering, Reunion, Spruce, Spyglass, Turbett Surgical, Xortx. Read More
Clinical updates for biopharma and med tech, including data readouts and publications: Ascendis, Context, Crinetics, Eli Lilly, Elicio, H. Lundbeck, Humacyte, Incyte, Intellia, Intrommune, J&J, Legend, Lyell, Marea, Mirum, Neumora, Orsobio, Rhythm, Spyre. Read More
Biopharma and med-tech happenings, including deals and partnerships, and other news in brief: Antharis, Faeth, Horizon, Lonza, Medtronic, Otsuka, SL, Scientia, Sensei, Transcend. Read More
Regulatory snapshots for biopharma and med tech, including global submissions and approvals, and other regulatory decisions and designations: Alk, Astrazeneca, Bayer, Belite, Guardant, Merck, Precigen, Roche, Sanofi. Read More
