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 ...

BASEL, Switzerland Roche Holding has agreed to the U.S. District Court for Massachusetts’ conditions in an attempt to gets its anemia drug Mircera on the market, according to the Wall Street Journal.

(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 ...

The battle between Roche and Amgen over the former’s bid to launch Mircera has taken a fresh turn with the news that the Swiss firm is appealing against a preliminary court injunction that prevents US ...

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 ...

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 ...

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 ...

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 ...

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 ...