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
Marengo Therapeutics has presented early-stage results from its STARt-002 clinical trial evaluating invikafusp alfa (Invika), a novel T cell immunotherapy candidate, in combination with sacituzumab govitecan (TRODELVY), an antibody-drug conjugate developed by Gilead Sciences. The data, shared during a late-breaking presentation at the 2025 San Antonio Breast Cancer Symposium, highlight the safety, pharmacodynamic activity, and
Insilico Medicine has licensed its AI-discovered oral PHD inhibitor ISM4808 to TaiGen Biotechnology for exclusive development and commercialization in the Greater China region, including Mainland China, Hong Kong, Macau, and Taiwan. The deal follows Investigational New Drug clearance in China in 2023 and positions TaiGen to bring the asset into clinical trials targeting anemia associated
Alphyn Biologics has secured $25 million in a twice-oversubscribed Series B financing round to support its clinical pipeline for dermatologic conditions. The funding will enable the company to advance a global Phase 2b trial of its lead asset, Zabalafin Hydrogel, for atopic dermatitis, while also launching a second Phase 2 program for molluscum contagiosum virus.
Swedish Orphan Biovitrum AB has received a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use for Aspaveli, the pegcetacoplan-based therapy developed in partnership with Apellis Pharmaceuticals Inc., for the treatment of C3 glomerulopathy and primary immune-complex membranoproliferative glomerulonephritis. The recommendation covers use in patients aged 12 years and older
Ractigen Therapeutics has initiated human testing of RAG-18, a novel small activating RNA (saRNA) therapeutic candidate for Duchenne muscular dystrophy (DMD), by dosing the first patient in an investigator-initiated trial at Peking Union Medical College Hospital in Beijing. The study is being led by Professor Dai Yi, a recognized expert in neuromuscular disorders, and will
Actinium Pharmaceuticals, Inc. has presented new preclinical data for its alpha-particle radiotherapy candidate ATNM-400 at the 2025 San Antonio Breast Cancer Symposium (SABCS), highlighting potent anti-tumor activity across hormone receptor–positive, triple-negative, and therapy-resistant breast cancer models. The findings suggest that ATNM-400 could become a differentiated treatment option for patients with tumors that have progressed after