Immvira Group Co.’s oncolytic herpes simplex virus product, MVR-T3011, showed early efficacy via intravesical administration in patients with high-risk BCG-failure non-muscle invasive bladder cancer.
With an eye on shutting down national security threats and securing American innovation, the U.S. House overwhelmingly passed the Biosecure Act Sept. 9 with a vote of 306-81. The next stop on the bill’s path to enactment is a Senate vote and, if it gets that, then on to the president’s desk.
Australia’s Health Department has released the final report of the Health Technology Assessment (HTA) Review that makes 50 recommendations for improving access to new health technologies while tackling inequity, simplifying HTA processes and making it easier for consumers and clinicians to participate.
Clinical updates from Asia, including trial initiations, enrollment status and data readouts and publications: Apollomics, Astrazeneca, Biogen, Hightide, Innovent, QL Biopharmaceutical, Ractigen, Telix.
Regulatory snapshots, including drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations in Asia-Pacific: Arcturus.
Biopharma happenings in Asia-Pacific including deals and partnerships, grants, preclinical data and other news in brief: Encell, Kazia, KM Biologics, Lucy Biotech, Oncopeptides, Osivax, SCBio.
More than three months ago, investors first learned that ivonescimab, a PD-1/VEGF-targeting bispecific antibody from Summit Therapeutics and Akeso Pharmaceuticals Inc., bested Keytruda (pembrolizumab) in PD-L1-positive non-small-cell lung cancer (NSCLC). At the 2024 World Conference on Lung Cancer over the weekend, Summit rolled out detailed data from the phase III Harmoni-2 trial, which included a nearly doubling of progression-free survival for ivonescimab compared to Merck & Co. Inc.’s established blockbuster drug.
Technological breakthroughs are changing the biopharmaceutical landscape and forcing regulators to think on their feet and facilitate (not impede) innovation, experts said at the Global Bio Conference (GBC) 2024. “Regulatory speed and agility are necessary amid emergencies to cater to unmet medical needs,” Choong May Ling, CEO of Singapore’s Health Sciences Authority, told audience members in Seoul, South Korea.
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