Vaxxas Pty Ltd, the Australian biotechnology company known for its high-density microarray patch (HD-MAP) platform, has secured a manufacturing licence from the Therapeutic Goods Administration (TGA) to produce its investigational vaccine delivery system under Good Manufacturing Practice (GMP) conditions. The licence, granted for its Brisbane-based biomedical facility, clears a critical regulatory hurdle and allows Vaxxas […]
TuHURA Biosciences, Inc. has announced a comprehensive corporate update that includes progress across three of its major immuno-oncology programs. The update covers the company’s lead asset IFx-2.0, currently in a Phase 3 trial in combination with pembrolizumab for advanced Merkel cell carcinoma; the next-stage development of TBS-2025, a VISTA-blocking monoclonal antibody being advanced for relapsed […]
Neurizon Therapeutics Limited has received clearance from the United States Food and Drug Administration for its investigational therapy NUZ-001 to be included in the HEALEY ALS Platform Trial, a globally recognized adaptive trial framework for amyotrophic lateral sclerosis. The decision formally designates NUZ-001 as Regimen I in the platform, allowing clinical site activation and study […]
Innovent Biologics has reported that mazdutide, its dual GLP-1 and glucagon receptor agonist, achieved statistically significant reductions in both body mass index and weight in Chinese adolescents with obesity during a 12-week Phase 1b clinical trial. The trial met its primary endpoint, demonstrated a favorable safety profile, and paves the way for a Phase 3 […]
NanOlogy, LLC, a Texas-based clinical-stage oncology company, has announced the launch of a drug development program focused on diffuse intrinsic pontine glioma, known as DIPG, a universally fatal pediatric brainstem tumor. The company is advancing Large Surface Area Microparticle Cisplatin, or LSAM-cisplatin, designed for stereotactic intratumoral administration in children. Investigational New Drug–enabling studies are underway, […]
Guardant Health brings its Guardant360 CDx test to Policlinico Gemelli in Italy. Find out how in-house liquid biopsy could reshape cancer diagnostics in Europe.
Eli Lilly and Indiana University are launching a $40M clinical trial and Alzheimer’s research initiative in Indiana. See what it could mean for U.S. pharma.
