Baxter data files FEIBA NF BLA with FDA for prophylactic treatment of hemophilia A or B Baxter International Inc. today announced that the business offers submitted a biologics permit application health supplement to the U.S anmeldelser . Food and Medication Administration for the authorization of prophylaxis treatment of FEIBA NF [Anti-Inhibitor Coagulant Complex], Vapor and Nanofiltered Heated, in sufferers with hemophilia A or inhibitors and B. As many as 1 / 3 of individuals with hemophilia develop an inhibitor to aspect replacement used to take care of or prevent bleeding episodes. The current presence of an inhibitor makes response to treatment more difficult, and sufferers with inhibitors possess an increased threat of developing problems such as for example joint damage.
Bavarian Nordic receives SPA for Stage 3 research of PROSTVAC for advanced prostate cancer Bavarian Nordic A/S declared today that the business has received a letter of concurrence from the U.S. Meals and Medication Administration on a particular Protocol Evaluation for a Stage 3 study necessary for product registration because of its product applicant, PROSTVAC, for the treating sufferers with asymptomatic or symptomatic metastatic castration-resistant prostate cancer minimally. This contract reached with the FDA upon this SPA implies that the Phase 3 research can proceed as designed and, if successful, can form the principal clinical basis of item acceptance under a Biologics Licence Program.