On January 23, 2025, the District Court for the District of New Jersey entered a Consent Judgment and Injunction in view of a ...

As Sandoz gears up to launch one of the most anticipated biosimilars of the year, the company could face near-term ...

US biotech major Amgen =announced that it has reached resolution of its patent infringement litigation related to South Korea ...

Dialysis patients on denosumab (Prolia, Xgeva) had a lower risk for fracture but higher risk for a certain heart event, suggested an observational trial weighted to emulate a clinical trial.

In 2024, the FDA approved 19 biosimilars across various therapeutic areas, including the first biosimilars for ustekinumab ...

No dedicated clinical trials have compared denosumab and bisphosphonates for fracture prevention in patients on dialysis.

For dialysis-dependent patients treated for osteoporosis, denosumab is associated with a greater preventive effect on fractures but an increased risk for major adverse cardiovascular events (MACE) ...

Sandoz has claimed the first FDA approvals for biosimilars of Amgen’s blockbuster bone disease therapy denosumab, but has not said when it plans to launch them onto the US market. Amgen sells ...

FDA committee recommends Amgen's denosumab, for the treatment, but not prevention, of bone loss, while Lilly decides not to submit arzoxifene for regulatory review after 5-year trial. Later this ...

Novartis' soon-to-be-divested Sandoz unit has positive clinical trial data in hand for a biosimilar of Amgen's blockbuster osteoporosis therapy Prolia (denosumab), clearing the way for regulatory ...