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Mircera belongs to a class of drugs known as erythropoiesis stimulating agents, or ESAs, that have been the subject of a safety review by the FDA.
The technique, using SARCOSYL-PAGE, has specifically enhanced sensitivity for MIRCERA, but does not alter the performance characteristics of SDS-PAGE for detecting other EPOs.
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 ...
Mircera is an erythropoietin receptor activator with greater activity in vivo as well as increased half-life, in contrast to erythropoietin. It is formulated as a sterile, preservative-free ...
The judge refereeing the turf battle between Roche and Amgen over anemia meds has taken a time-out to consult the experts. Judge William Young said he's grappling "with complex issues" in the patent ...
LONDON (MarketWatch) -- Swiss drugmaker Roche said Friday that it has received a positive opinion from the European Committee for Medicinal Products for Human Use (CHMP) recommending a marketing ...
Amgen Inc. has won a key patent trial that it hopes will prevent Roche Holding AG from launching its anemia drug Mircera in the U.S. The victory Tuesday will likely protect Amgen's most valuable ...
Roche said it would begin taking steps to market Mircera if the judge doesn't rule on Amgen's injunction request on Feb. 28, when oral arguments are scheduled in the case.
FDA delay on Mircera a reprieve for Amgen, J&J . The FDA delayed an approval decision on Roche’s Mircera pending a fall advisory committee review, spelling temporary relief for marketers of similar ...
Amgen Inc. said a federal court granted the biotechnology company a permanent injunction prohibiting Roche Holding AG from selling its Mircera anemia treatment in the U.S., while also upholding a ...