FDA clears mAbxience–Amneal denosumab biosimilars, opening a new front in osteoporosis and oncology pricing

By on    Pharma & Biotech  

FDA clears mAbxience–Amneal denosumab biosimilars, opening a new front in osteoporosis and oncology pricing

mAbxience and Amneal Pharmaceuticals have secured U.S. Food and Drug Administration (FDA) approval for two denosumab biosimilars, Boncresa and Oziltus, referencing Prolia and XGEVA respectively, clearing a long-anticipated regulatory hurdle in osteoporosis and oncology supportive care. The approvals position Amneal Pharmaceuticals as the exclusive U.S. commercial partner, with mAbxience responsible for development and manufacturing, marking […]

Why Sōlaria Biō’s new gut–bone research could disrupt standard osteoporosis care

By on    Pharma & Biotech  

Why Sōlaria Biō’s new gut–bone research could disrupt standard osteoporosis care

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 […]