Bantam Pharmaceutical has treated the first patient with BTM-3566 in a Phase 1 clinical trial at the Princess Margaret Cancer Centre in Toronto. The study marks the first-in-human administration of the company’s lead investigational therapy, a first-in-class small molecule designed to treat aggressive cancers by modulating the OMA1-ATF4 integrated stress response pathway. This trial includes […]
Innoviva Specialty Therapeutics has received approval from the U.S. Food and Drug Administration for NUZOLVENCE (zoliflodacin), a first-in-class, single-dose oral antibiotic for the treatment of uncomplicated urogenital gonorrhea in adults and adolescents. This approval, based on the largest-ever Phase 3 clinical trial for a new treatment against Neisseria gonorrhoeae, marks the first new oral gonorrhea […]
Cellenkos, Inc., a clinical-stage biotechnology company developing allogeneic regulatory T cell (Treg) therapies, has unveiled new data from its investigational product CK0804, presented at the 67th American Society of Hematology (ASH) Annual Meeting. The findings highlight the potential of a dose-intensive regimen of CK0804 to reduce spleen volume, improve symptoms, and lower transfusion dependence in […]
ImmunityBio Inc. has received a positive recommendation from the European Medicines Agency for conditional marketing authorization of its immunotherapy ANKTIVA (nogapendekin alfa inbakicept) in combination with Bacillus Calmette-Guérin for the treatment of BCG-unresponsive non-muscle invasive bladder cancer carcinoma in situ. The recommendation positions ANKTIVA as the first immunotherapy in the European Union for this indication, […]
Veritiv Operating Company has launched TempSafe PalletShield, a pre-qualified, fiber-based pallet shipper for cold chain logistics, designed to offer curbside recyclability without compromising thermal performance. The system delivers more than five days of validated temperature control and is capable of holding up to 596 liters and 300 pounds of dry ice, specifically targeting the needs […]
Innoviva Specialty Therapeutics has reported publication of pivotal Phase 3 data in The Lancet showing that its investigational oral antibiotic zoliflodacin was non-inferior to the current standard-of-care dual therapy for uncomplicated urogenital gonorrhea. The study, conducted in partnership with the Global Antibiotic Research & Development Partnership, or GARDP, compared a single oral dose of zoliflodacin […]
Indivumed GmbH and the Wilmot Cancer Institute at the University of Rochester Medical Center have expanded their collaboration to accelerate the development of patient-derived tumor models and AI-informed therapeutic discovery for solid tumors with high unmet clinical need. What this collaboration changes for the cancer model ecosystem The expansion of the Indivumed and University of […]
Kazia Therapeutics Limited has presented new clinical and translational data at the 2025 San Antonio Breast Cancer Symposium demonstrating that paxalisib, its investigational brain-penetrant PI3K/mTOR inhibitor, may suppress circulating tumor cell clusters and reverse immune exhaustion in two of the most treatment-resistant breast cancer subtypes—HER2-positive metastatic breast cancer and triple-negative breast cancer. The early evidence, […]
Diakonos Oncology Corporation has received over $7 million from the Cancer Prevention and Research Institute of Texas to initiate a Phase 1/2 clinical trial of its double-loaded dendritic cell therapy, DOC1021, in patients with refractory melanoma. The grant places the investigational therapy into its third solid tumor indication and signals rising institutional interest in immune-based […]
Natera Inc. and Medica Scientia Innovation Research (MEDSIR) have announced a collaborative effort on the MiRaDoR study, a multicenter, phase II clinical trial focused on hormone receptor-positive, HER2-negative (HR+/HER2-) breast cancer. Sponsored by MEDSIR and funded by F. Hoffmann-La Roche Ltd., the trial uses Natera’s Signatera assay to guide therapy decisions based on circulating tumor […]