Renal Business Today

Anemia

OIG: CMS Could Save Millions by Adjusting ESRD Bundle for Anemia Drugs

The Centers for Medicare & Medicaid Services could have saved $529 million if the end-stage renal disease payment bundle had been adjusted to reflect current utilization of anemia management drugs, the Office of Inspector General concluded this week in a new report. ...More
5 days ago
Posted in News
Slide Show: Dialysis Anemia Trends

The following analyses are selected excerpts from the full report and are presented across all respondents. Other subgroup analyses such as by practice setting, dialysis modality, and size of dialysis organization are not presented. Customized analyses upon request. ...More
2 weeks ago
Posted in Galleries
Omontys Recalled: Affymax, Takeda Looking for Root Cause

On Sunday, February 24, Omontys (peginesatide), which was approved in March 2012 by the U.S. Food and Drug Administration (FDA), was voluntarily recalled by Affymax and Takeda due to reports of fatalities and severe hypersensitivity reactions. Since the incident, Affymax ...More
March 8, 2013
Posted in Articles, Business
Management of Anemia in Children on Dialysis Examined

WASHINGTON —Children on dialysis who have anemia and who require high doses of drugs to treat it have an increased risk of dying prematurely, according to a study appearing in an upcoming issue of the Journal of the American Society of Nephrology (JASN). The findings ...More
March 8, 2013
Posted in News, Clinical & Pharma
Affymax CEO Discusses Omontys Recall

PALO ALTO, Calif.— Affymax CEO John Orwin spoke up February 25 regarding the voluntary recall of its FDA-approved anemia drug Omontys (peginesatide). ...More
February 27, 2013
Posted in News, Business
Affymax, Takeda Recall Omontys Due to Reactions, Deaths

PALO ALTO, Calif.— Affymax Inc. and Takeda Pharmaceuticals are voluntarily recalling all lots of the anemia drug Omontys after reports of fatalities and anaphylaxis, a life-threatening allergic reaction. ...More
February 25, 2013
Posted in News, Business
New England Journal of Medicine Publishes Pivotal Trial Data for Omontys

PALO ALTO, Calif. & DEERFIELD, Ill.—Affymax and Takeda Pharmaceuticals U.S.A. announced that pivotal Phase 3 data on the safety and efficacy of Omontys were published in the January 24 issue of the New England Journal of Medicine (NEJM). These studies, known as EMERALD ...More
January 24, 2013
Posted in News
Takeda, Affymax Announce Supply Agreement for Omontys with DSI Renal

DEERFIELD, Ill. & PALO ALTO, Calif.—Takeda Pharmaceuticals U.S.A. and Affymax announced that Takeda Pharmaceuticals America has entered into a supply agreement for sourcing and supply of Omontys (peginesatide) Injection with DSI Renal. Omontys is the only once-monthly ...More
January 8, 2013
Posted in News
Affymax and Takeda Announce Permanent J-Code for Omontys Injection

PALO ALTO, Calif. & DEERFIELD, Ill.—Affymax and Takeda Pharmaceuticals U.S.A. (TPUSA) announced that the J-code assigned by the Centers for Medicare and Medicaid Services (CMS) for Omontys (peginesatide) Injection is now effective. This permanent Omontys-specific ...More
January 2, 2013
Posted in News, Clinical & Pharma
AMAG Pharmaceuticals Announces FDA Submission of Supplemental Drug Application for Feraheme

LEXINGTON, Mass.—AMAG Pharmaceuticals announced that it has submitted a supplemental new drug application (sNDA) to the United States Food and Drug Administration (FDA) for Feraheme (ferumoxytol) Injection for Intravenous (IV) use. ...More
December 28, 2012
Posted in News, Business