Tag Archive for: Phase III trial

The British drugmaker’s shot, called Arexvy, met the primary goal in the Phase-III trial of eliciting an immune response in adults of the reported age group who are at an increased risk of catching the virus due to certain underlying medical conditions, the company said.

Pluvicto improved radiographic progression-free survival in PSMA-positive patients with metastatic castration-resistant prostate cancer who had not been treated with taxane-based chemotherapy.

The competitors posted promising survival data for their respective blockbuster PD-1 inhibitors—Keytruda and Opdivo—emphasizing the potential of these therapies in bladder cancer patients.

Early stage ALK-positive non-small cell lung cancer patients treated with Roche’s Alecensa saw an “unprecedented” 76% drop in the risk of recurrence or death, the company announced.

Dialysis giant DaVita raised concerns over Novo Nordisk’s interim analysis of a kidney outcomes study of semaglutide, pointing to the potentially limited applicability of the findings.

Following the recommendations of an independent Data Monitoring Committee, Novo Nordisk has halted a Phase III kidney outcomes study of semaglutide ahead of schedule due to strong efficacy signals.

At the six-month follow-up, about 40% of patients treated with Newron Pharmaceuticals’ evenamide improved so much that they no longer meet the Phase II study’s original eligibility criteria.

Merck on Thursday reported that its blockbuster PD-1 inhibitor Keytruda (pembrolizumab) met one of its dual primary endpoints in the Phase III AMBASSADOR trial in muscle-invasive urothelial carcinoma.

Amgen’s regulatory ambitions for its non-small cell lung cancer drug Lumakras (sotorasib) ran into headwinds Tuesday, after FDA staff indicated in their briefing document that there might not be sufficient evidence of its efficacy to justify full approval.

With Intercept’s failure to emerge as the non-alcoholic steatohepatitis market leader, Madrigal Pharmaceuticals is seeking to take leadership of the space fueled by a half-a-billion-dollar public offering.