Pharma Business - April 17, 2016
Veloxis moves Danish activates to the US
Veloxis Pharmaceuticals A/S has decided to close its office in Hørsholm, Denmark, and move all activities to the US where most of the company’s current activities is already located. The process is expected to be completed during the second half of 2016. “As most of the company’s activities are located in the U.S. combined with […]
Drug Development Pharma - April 22, 2015
More Good News for Kidney Transplant Drug
Trials of once-daily Envarsus® XR, an investigational drug under FDA review for the prevention of organ rejection in adult kidney transplant patients, demonstrated that a lower dose in African-American patients is sufficient for therapeutic tacrolimus blood concentrations, compared to twice-daily immediate release tacrolimus, according to Veloxis. Veloxis is seeking an order requiring the FDA to […]
Regulatory compliance - December 22, 2014
Veloxis Responds to Court Order
Veloxis Pharmaceuticals A/S commented on an order issued by the U.S. District Court for the District of Columbia in connection with the action it filed on December 16 against the U.S. Food and Drug Administration (FDA). Veloxis is seeking an order requiring the FDA to grant final approval to Envarsus(® )XR. “We are pleased that […]
Companies - December 18, 2014
Veloxis Files Suit Against FDA
Denmark’s Veloxis Pharmaceuticals A/S announced that it has filed an action in federal district court for the District of Columbia against the U.S. Food and Drug Administration, seeking an order requiring the FDA to grant final approval to Envarsus® XR. Envarsus XR is a once-daily extended-release tablet indicated for prophylaxis of organ rejection in kidney […]
