- In May 2024, GSK plc announced that the U.S. Food and Drug Administration (FDA) approved a 200 mg subcutaneous formulation of Benlysta (belimumab), a monoclonal antibody that specifically inhibits B-lymphocyte stimulator (BLyS). This approval allows for treatment in patients aged five years and older with active systemic lupus erythematosus (SLE) who are already receiving standard therapy. The extension of Benlysta’s use to this new patient demographic is expected to significantly contribute to revenue growth for GSK. This milestone underscores the company’s commitment to advancing treatment options for individuals affected by SLE
- In September 2024, Otsuka Pharmaceutical Co., Ltd. announced that it had submitted a New Drug Application (NDA) in Japan for OPC-34712 (brexpiprazole) as a treatment for agitation associated with dementia of the Alzheimer's type. This application marks a significant step in expanding the company's central nervous system (CNS) portfolio, highlighting its continued efforts to address unmet medical needs in neuropsychiatric disorders
- In March 2025, Roche reported positive interim results from its Phase III SKYSCRAPER-08 study evaluating the efficacy of tiragolumab, its novel anti-TIGIT immunotherapy, in combination with atezolizumab for patients with unresectable, locally advanced, or metastatic esophageal squamous cell carcinoma (ESCC). These findings demonstrate Roche’s strategic commitment to pioneering next-generation immuno-oncology treatments targeting difficult-to-treat cancers
- In July 2024, Biogen and UCB announced positive topline results from their Phase 3 study evaluating zilucoplan, a complement C5 inhibitor, in patients with generalized myasthenia gravis (gMG). The trial met its primary endpoint, showing statistically significant improvements in disease severity. This milestone further strengthens Biogen’s position in the neurology space and underscores UCB’s focus on delivering transformative therapies for rare autoimmune conditions
