On the eve of the June 17 Vaccines and Related Biological Products Advisory Committee (VRBPAC) meeting, which will discuss Moderna Inc.’s mRNA-1010, researchers at Washington University School of Medicine in St. Louis have reported that the vaccine conferred broader and more durable protection than a standard flu shot.
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.
Biopharma and med-tech happenings, including deals and partnerships, and other news in brief: Antharis, Faeth, Horizon, Lonza, Medtronic, Otsuka, SL, Scientia, Sensei, Transcend.
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.
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.
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.
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.
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.
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.
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