Life Sciences News - Friday Aug 7 2026
Replimune's Tudriqev granted accelerated approval after two setbacks
FDA granted accelerated approval to Replimune’s melanoma therapy, Tudriqev (previously known as RP1) in combination with Bristol Myers Squibb’s Opdivo (nivolumab) in adult patients who experienced tumor progression despite prior anti-PD-1 therapy. Tudriqev (vusolimogene oderparepvec-wtpg) is a oncolytic viral immunotherapy based on a modified herpes simplex virus type 1 (HSV-1) that is injected directly at the tumor sites to eliminate cancer cells and trigger immune response to target cancer cells elsewhere. It is used in combination with the anti-PD-1 immunotherapy nivolumab. The FDA approval came after two prior rejections citing lack of control group in Phase 1/2 single-arm IGNYTE trial and unclear effectiveness in relation to the accompanying nivolumab. The approval is backed by clinical data that 24.2% patients responded to treatment with shrinking or disappearing tumors with a median response of 14.1 months. Replimune anticipates more data to verify the clinical benefit and continue the approval in a confirmatory late-stage trial that is expected to be concluded in 2030.
FDA approves Moderna's new mRNA flu vaccine
Moderna’s mRNA-based vaccine, mFlusiva, is approved for people ages 50 to 64 against seasonal influenza. Accelerated approval is granted for use in adults ages 65 or older contingent on results from a postmarketing study to confirm the clinical benefit. mFlusiva is the first of mRNA-based vaccine and marks the continuing expansion of Moderna’s respiratory portfolio.
Alteogen licenses subcutaneous biologic based on Hybrozyme platform
Alteogen signs a $365m exclusive licensing deal with an undisclosed global pharma to develop and commercialize a subcutaneous biologic product utilizing ALT-B4 (berahyaluronidase alfa), a recombinant human hyaluronidase developed using Alteogen’s Hybrozyme platform. Alteogen's Hybrozyme platform is a proprietary drug-delivery technology designed to convert traditional intravenous (IV) biologic drugs into rapid subcutaneous (SC) injections. Its core product, ALT-B4 (a proprietary recombinant human hyaluronidase enzyme), temporarily breaks down hyaluronan in skin tissue to allow large-volume drug dispersion under the skin.
