Sen-Jam Pharmaceutical has disclosed a significant equity-based agreement with TASK Clinical, under which the global contract research organization will fund two-thirds of the Phase 3 trial for SJP-001. The candidate, a first-in-class therapy targeting alcohol-induced inflammation, now becomes one of the few mid-stage biotech programs to receive such substantial CRO-driven capital support. The partnership is […]
Sōlaria Biō has disclosed new mechanistic data showing that its synbiotic medical food, Bondia, reinforces gut barrier integrity, reduces systemic inflammation, and suppresses osteoclast activity—offering biological insight into the 85 percent improvement in bone density reported in a prior large-scale clinical trial. These results support Bondia’s positioning as a novel intervention for osteopenia and age-related […]
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 […]
Anixa Biosciences Inc. has reported final Phase 1 results for its investigational breast cancer vaccine targeting the α-lactalbumin protein, showing that the primary endpoints were met and 74 percent of participants demonstrated protocol-defined immune responses. The data were presented at the 2025 San Antonio Breast Cancer Symposium and build the case for a Phase 2 […]
A new phase III clinical trial published in The Lancet has shown that proton therapy significantly improves overall survival and reduces treatment-related toxicities in patients with oropharyngeal cancers compared to traditional photon-based radiation. Conducted across 21 U.S. institutions and led by researchers at the University of Texas MD Anderson Cancer Center, the study is the […]
Amgen has received approval from the United States Food and Drug Administration for Uplizna (inebilizumab-cdon) to treat adults with generalized myasthenia gravis who are anti-acetylcholine receptor or anti-muscle specific tyrosine kinase antibody positive. The greenlight makes Uplizna the first and only CD19-targeted B cell therapy approved for this patient population, introducing a twice-yearly dosing regimen […]
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 […]
Akeso Inc. has secured clearance from the United States Food and Drug Administration to initiate COMPASSION-37, a global Phase III trial evaluating cadonilimab, a first-in-class PD-1/CTLA-4 bispecific antibody, as part of a first-line treatment regimen for HER2-negative, unresectable or metastatic gastric and gastroesophageal junction adenocarcinoma. The randomized, multicenter trial will compare cadonilimab plus chemotherapy against […]
Orphalan, the international pharmaceutical company known for developing orphan drugs, has announced the acquisition of Orphelia Pharma, a specialist in rare and severe pediatric diseases. The deal enhances Orphalan’s position in the European rare disease market, particularly within pediatric neurology and oncology, and signals a strategic pivot toward deeper vertical integration in pediatric formulations and […]
STADA Arzneimittel AG and Bio-Thera Solutions have secured a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use for Gotenfia, a proposed biosimilar to the tumor necrosis factor alpha inhibitor golimumab. The product references Simponi, an originator drug widely prescribed for multiple autoimmune conditions. If approved, Gotenfia would be marketed […]
