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

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.

Compared with oral bisphosphonate use, denosumab use was associated with a 45% lower risk for fractures among patients on dialysis. Cardiovascular risk was 36% higher with denosumab. Among adults ...

Patients on dialysis who take denosumab face a 36% higher risk for major cardiovascular adverse events than patients who take oral bisphosphonates, according to a study published Jan. 6 in Annals ...

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

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 ...

a proposed denosumab biosimilar to Amgen’s PROLIA and XGEVA. GlyCoNex is a clinical stage biotechnology company focused on the development of glycan-directed cancer immunotherapies. The licensee ...

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 ...

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 ...

Results of the study showed that CT-P41 had equivalent efficacy and PD to reference denosumab, with similar PK and comparable safety and immunogenicity profiles. 2 About CT-P42 Phase III Clinical ...