The approval was based on an open-label, multiple dose, multicenter, dose-finding study in 64 pediatric patients with CKD who were on hemodialysis and who had stable hemoglobin levels while previously ...

The FDA delayed an approval decision on Roche’s Mircera pending a fall advisory committee review, spelling temporary relief for marketers of similar biologics.Mircera, an experimental treatment for ...

Researchers have successfully developed a new electrophoretic method for detecting MIRCERA and other erythropoietins (EPO) in the blood. The technique, using SARCOSYL-PAGE, has specifically enhanced ...

Roche announced today that the U.S. Food and Drug Administration (FDA) has approved Mircera (methoxy polyethylene glycol-epoetin beta) for the treatment of anaemia associated with chronic kidney ...

Roche announced today that the European Commission has approved its innovative drug Mircera to treat anaemia associated with chronic kidney disease (CKD). The approval of Mircera results in a single ...

In its ongoing fight with Roche, Amgen now has stronger backing from a federal court. The U.S. District Court in Boston ruled yesterday that Amgen should get a permanent injunction against Roche's ...

(CN) - The Federal Circuit refused to lift an injunction barring F. Hoffman-La Roche Ltd. from importing its anemia treatment, Mircera, to the United States, saying the drug infringes on some of Amgen ...

IN 2015 VIFOR PHARMA (FORMERLY A COMPANY OF GALENICA GROUP) ENTERED INTO AN EXCLUSIVE LICENSE AGREEMENT WITH ROCHE FOR THE COMMERCIALISATION OF ITS MEDICINE MIRCERA ® in the US. MIRCERA ® IS A ...

Please provide your email address to receive an email when new articles are posted on . The FDA approved Mircera for the treatment of pediatric patients 5 to 17 years of age on hemodialysis who are ...

Data from the analysis of six major trials for the innovative new renal anaemia treatment MIRCERA, have shown that it effectively corrects and maintains haemoglobin levels in chronic kidney disease ...

BASEL, Switzerland, March 5 /PRNewswire/ -- The results of a large-scale study of patients with chronic kidney disease (CKD) who are not on dialysis, and who have never received a treatment for ...