The recent FDA approval of Rubraca (rucaparib) for pre-chemotherapy use in BRCA-mutated metastatic castration-resistant prostate cancer marks a strategic inflection for the field. This expanded indication, driven by head-to-head superiority over docetaxel in the TRITON3 Phase 3 trial, positions BRCA mutations as the first molecular biomarker in prostate cancer to carry actionable, label-defining weight in […]
For much of the past two decades, monoclonal antibodies have dominated modern drug development. Their ability to bind with high specificity, block protein function, and engage immune mechanisms has transformed the treatment of cancer, autoimmune disorders, and infectious disease. But despite their blockbuster status, biologics have a blind spot. They are largely excluded from the […]
Mabwell Biopharmaceuticals has received Investigational New Drug (IND) clearance from the United States Food and Drug Administration to initiate a Phase IIa clinical study for its anti-ST2 monoclonal antibody, 9MW1911, in patients with moderate-to-severe chronic obstructive pulmonary disease. This regulatory milestone comes on the heels of a completed Phase IIa study in China, where Mabwell […]
In the decades-long war against disease, pharmaceutical companies have learned to build drugs like locksmiths—designing compounds that fit neatly into molecular pockets, disabling enzymes and receptors with surgical precision. But not every biological lock comes with a keyhole. Protein–protein interactions, or PPIs, often involve broad, flat, and shifting surfaces that refuse to conform to conventional […]
Menarini Silicon Biosystems has reported new secondary analysis results from the PACE trial, reinforcing the potential of its CELLSEARCH Circulating Tumor Cell (CTC) enumeration system as a predictive biomarker for guiding treatment escalation in hormone receptor-positive, HER2-negative metastatic breast cancer. Published in Clinical Cancer Research, the findings suggest that CTC counts in blood samples could […]
Takeda Pharmaceutical Company Limited has reported positive topline results from two pivotal Phase 3 studies of its investigational drug zasocitinib (TAK-279), a once-daily oral tyrosine kinase 2 (TYK2) inhibitor, in adults with moderate-to-severe plaque psoriasis. The trials met all primary and secondary endpoints, with more than 50 percent of participants achieving near-complete skin clearance (PASI […]
The U.S. Food and Drug Administration has approved Johnson & Johnson’s RYBREVANT FASPRO (amivantamab and hyaluronidase-lpuj), the first subcutaneous version of its bispecific EGFR-MET antibody therapy, for patients with EGFR-mutated non-small cell lung cancer (NSCLC). The approval spans all current RYBREVANT indications and is based on the Phase 3 PALOMA-3 study, which demonstrated comparable pharmacokinetics […]
Innovent Biologics, Inc. has achieved a landmark moment in China’s clinical research trajectory with the back-to-back publication of two Phase 3 clinical trials of mazdutide, a dual GCG/GLP-1 receptor agonist, in Nature as Accelerated Article Previews. These studies, known as DREAMS-1 and DREAMS-2, evaluated the drug as monotherapy and as an add-on therapy in Chinese […]
