Janssen Pharmaceutical Inc.
NEWS
The approval is based on the Phase III UNIFI study that showed that after eight weeks of taking a single intravenous dose of Stelara, patients saw “clinical remission in a significantly greater proportion of UC patients.”
Last week was busy for clinical trial news. Here’s a look.
Janssen Pharmaceutical of Johnson & Johnson released new long-term data from the open-label period of its Phase III VOYAGE 1 clinical trial.
The U.S. Food and Drug Administration approved Janssen Pharmaceutical’s Xarelto for the prevention of venous thromboembolism, or blood clots, in acutely sick patients in hospitals who are at risk for blood clots but who are not at high risk of bleeding.
Insilico Biotechnology AG and the Janssen Pharmaceutical Companies of Johnson & Johnson announced an agreement to apply Insilico’s predictive Digital Twins for the early selection of high-performing cells to further boost efficiency and throughput of their cell line development workflow.
Janssen’s Invokana snagged another regulatory approval to reduce the risk of end-stage kidney disease, cardiovascular death and worsening of kidney function in adults with type 2 diabetes and diabetic kidney disease.
Treatment with Erleada plus androgen deprivation therapy resulted in a 25% reduction in the risk of death compared to placebo in prostate cancer patients.
The FDA’s latest approval for Darzalex is based on results from the Phase III CASSIOPEIA trial that showed the addition of Darzalex to VTd before and after ASCT resulted in deeper responses in patients with the blood cancer.
Phase 3 TITAN is the first registrational study to achieve statistical significance in dual primary endpoints of overall survival and radiographic progression-free survival in patients with mCSPC regardless of extent of disease
JOBS
IN THE PRESS