Intellectual Property - February 5, 2015
FDA, Veloxis Dispute Continues
The U.S. Food and Drug Administration (FDA) has informed Veloxis Pharmaceuticals A/S that the FDA still maintains that the exclusivity for Astagraf XL should require delays in the formal approval of Envarsus® XR. The FDA has stated that it would be prepared to approve Envarsus XR for use only in patients transitioned from an immediate […]
Clinical Trials - January 22, 2015
Astra’s Brilinta Gets a Boost
On the heels of positive outcomes from a second study of the blood thinner Brilinta, AstraZeneca plans to use the results to bolster an application to the U.S. Food and Drug Administration (FDA) to expand and extend the use of the anti-platelet drug. Called the Pegasus study, it followed 21,000 patients who’d had heart attacks and found that long-term use of Brilinta in […]
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 […]
Drug Development Pharma - November 21, 2014
Joint Bionor, FDA Study Possible
Norwegian company Bionor Pharma is in talks with the U.S. Federal Drug Administration (FDA) about a possible collaboration on a study to test a trial HIV vaccine early next year. Bionor reported strong results in one of its tests of vaccine Vacc-4x in combination with the drug Revlimid. Vacc-4x works by activating the body’s immune system to kill […]
New Market - November 3, 2014
FDA approves AstraZeneca’s XIGDUO
The US Food and Drug Administration has approved AstraZeneca’s once-daily XIGDUO XR (dapagliflozin and metformin hydrochloride extended-release) for the treatment of adults with type 2 diabetes. XIGDUO XR is the first and only once-daily combination tablet of an SGLT2 inhibitor and metformin HCl extended-release to be approved in the United States. XIGDUO XR is indicated […]
