Renal Business Today

U.S. Food And Drug Administration (FDA)

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
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
Kidneys Sometimes Removed Unnecessarily Due to Misdiagnosis of Genetic Disorder

CINCINNATI, Ohio—Thousands of individuals have had kidneys removed unnecessarily because doctors misdiagnosed their disease. ...More
January 11, 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
Earlier Endpoints Proposed for Clinical Trials in CKD

NEW YORK—The U.S. Food and Drug Administration (FDA) is now considering new endpoints for clinical trials in chronic kidney disease (CKD) patients as a result of a special scientific workshop convened by the National Kidney Foundation (NKF) and the FDA on December 3-4 in ...More
December 5, 2012
Posted in News, Clinical & Pharma
FDA Grants Diazyme Clearance to Market a New Biomarker for Early Detection of Kidney Disease

LA JOLLA, Calif.— Diazyme Laboratories announced that the U.S. Food and Drug Administration (FDA) has granted Diazyme 510(k) clearance to market its Cystatin C POC Test Kit on the SMART Point of Care System. The SMART Point of Care chemistry system offers a wide range of ...More
November 13, 2012
Posted in News, Clinical & Pharma
Curing Kidney Disease: Dream or Reality?

SAN DIEGO—Ronald J. Falk, MD, FASN, president of the American Society of Nephrology (ASN), the world’s largest professional society devoted to the study of kidney disease, urges his colleagues to envision a cure for kidney disease. ...More
November 1, 2012
Posted in News, Government & Regulation
UCSF Artificial Kidney Project Receives $3 Million in New Funding

SAN FRANCISCO—A $750,000 gift from the John and Marcia Goldman Foundation is spurring a UCSF-led effort to create the first implantable artificial kidney for patients with kidney failure. ...More
October 2, 2012
Posted in News, Government & Regulation
New Partnership Between ASN, FDA to Advance Treatment for Patients with Kidney Disease

WASHINGTON—The American Society of Nephrology (ASN) and the U.S. Food and Drug Administration (FDA) are pleased to announce a new partnership: the Kidney Health Initiative (KHI). ...More
September 27, 2012
Posted in News, Government & Regulation, Practice Management