HyClone Laboratories, LLC (“HyClone”), a cell culture media supplier, filed a Motion to Quash a subpoena issued by Amgen, ...

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.

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 ...

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

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 ...

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

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 ...

Alongside margin recovery, Biocon Biologics has also gained market share, with oncology remaining a key focus area.

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 ...