Renal Business Today

U.S. Food And Drug Administration (FDA)

Rockwell Completes Patient Enrollment for Phase 2b Study

WIXOM, Mich.—Rockwell Medical Technologies, Inc., a manufacturer and developer of concentrates and specialty pharmaceuticals for dialysis patients, reported that patient enrollment has been completed for its ongoing Phase 2b dose-ranging study for its iron deficiency anemia ...More
April 30, 2009
Posted in News, Business, Clinical & Pharma, Practice Management
WHO Raises Swine Flu Pandemic Alert to Phase 5

GENEVA—The World Health Organization on Wednesday raised its pandemic alert to phase 5, which indicates that the swine flu is spreading from human to human and nearing the pandemic phase. ...More
April 29, 2009
Posted in News, Business, Clinical & Pharma, Practice Management
Rockwell Medical Updates DSMB Interim Results

WIXOM, Mich.—Rockwell Medical Technologies, Inc., a manufacturer and developer of concentrates and specialty pharmaceuticals for dialysis patients, reported the independent Data Safety Monitoring Board (DSMB) providing oversight for the ongoing SFP Phase 2b dose-range study ...More
April 16, 2009
Posted in News, Business, Clinical & Pharma
FDA: Pharmacies Will Change Dramatically by 2019

By 2019 a typical pharmacy will display extensive racks of self-testing kits for the risks of gene-associated diseases and a counseling center along side the prescription counter, where the pharmacist will help patients manage drugs designed for their personal genetic ...More
March 18, 2009
Posted in News, Government & Regulation
Obama Announces FDA Commissioner

WASHINGTON—President Barack Obama named Dr. Margaret Hamburg as commissioner of the U.S. Food and Drug Administration and Dr. Joshua Sharfstein as the principal deputy commissioner. ...More
March 18, 2009
Posted in News, Business, Government & Regulation
FDA to Review 2 Proposed Diabetes Drugs

WASHINGTON—The U.S. Food and Drug Administration’s Endocrinologic and Metabolic Drugs Advisory Committee will review two proposed drugs to treat Type 2 diabetes next month, reported CNN.The committee will discuss Bristol-Myers Squibb Co.'s saxagliptin tablets on ...More
March 9, 2009
Posted in News, Business, Clinical & Pharma, Government & Regulation
Genzyme Transitions Renagel Users to Renvela

Earlier this year, Cambridge, Mass.-based Genzyme Corp. announced that it’s working with physicians to transition all U.S. patients on the phosphate binder Renagel to Renvela by Sept. 30. ...More
February 26, 2009
Posted in Articles, Business, Clinical & Pharma, Government & Regulation
FDA Seeks Information on Nephros’ 510k Applications

RIVER EDGE, N.J.—Medical device company Nephros Inc. said it has received initial responses from the U.S. Food and Drug Administration’s review of the company's 510(k) submissions for dialysis devices. ...More
February 25, 2009
Posted in News, Business, Clinical & Pharma, Government & Regulation
FDA Sets New Standards for Heparin, Glycerin

ROCKVILLE, Md.—In a continuing effort to prevent counterfeit and adulterated medications from reaching American consumers, the U.S. Food and Drug Administration (FDA) is adopting stricter standards for heparin and glycerin—two widely used drug products at the center of ...More
February 5, 2009
Posted in News, Clinical & Pharma, Government & Regulation
EPO-Secreting Pump Effective in Treating Anemia in CKD

LONDON—Medgenics said Feb. 3 that its Epodure Biopump, which secretes erythropoietin into the body using tissue from a patient’s own skin, has successfully demonstrated safety and efficacy for the sustained protein therapy of anemia in chronic kidney disease patients. ...More
February 3, 2009
Posted in News, Clinical & Pharma, Government & Regulation