(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 ...
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.
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 ...
New data for Roche’s anaemia drug Mircera confirm that the drug can raise haemoglobin levels in the blood with twice-monthly dosing, suggesting it will mount a strong challenge to current treatments ...
Roche is appealing to a higher power on Mircera. The Swiss drugmaker is appealing a lower court ruling barring U.S. sales of the anemia med, claiming that Mircera doesn't infringe on Amgen's patents ...
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 ...
ZURICH, May 25 (Reuters) - Roche Holding AG's potential blockbuster drug Mircera has been cleared by European authorities, who recommended allowing sales to treat anaemia linked to kidney disease.
The FDA has approved Roche's anemia drug Mircera, but don't look for any big new product launches soon. Last month Amgen won a patent infringement case on the therapy. And Roche is studying its ...
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 ...