Latest news

• FDA advisory committee votes against approval of AZ, FibroGen's roxadustat

  According to analysis included in the FDA briefing documents, roxadustat was comparable to epoetin alfa, a standard therapy for anaemia in CKD, on the composite measure of major adverse cardiovascular events ... MACE). However, the FDA raised concerns

• FDA questions safety profile of AZ, FibroGen’s anaemia drug roxadustat

  According to this analysis, roxadustat was comparable to epoetin alfa, a standard therapy for anaemia in CKD, on the composite measure of major adverse cardiovascular events (MACE). ... events. The risk is thought to be most acute with epoetin alfa when

• GSK files anaemia drug daprodustat in Japan, its first market

  If approved, daprodustat would be an oral alternative to erythropoiesis-stimulating agents (ESAs) such as Kyowa Kirin’s Espo (epoetin alfa) and biosimilars that have to be delivered by injection.

• AZ preps new roxadustat filings, though data foxes investors

  events. The risk is thought to be most acute with epoetin alfa when treatment is started, typically in patients in newly-initiated (incident) dialysis. ... Epoetin alfa is sold by Amgen as Epogen and Janssen as Procrit, but these brands were joined by

• First-line ovarian approval cements AZ’s Lynparza lead

  The ROCKIES trial revealed a significant improvement for the oral drug in haemoglobin versus injectable epoetin alfa in dialysis-dependent CKD patients, the patient population for which it has just been