Renal Business Today

Secondary Hyperparathyroidism

Sensipar Label Gets Safety Update

The U.S. Food and Drug Administration has approved a change to the safety labeling of Amgen’s Sensipar (cinacalcet). ...More
September 13, 2011
Posted in Blog, Clinical & Pharma, Government & Regulation
Bundle Affects Secondary Hyperparathyroidism Treatment

EXTON, Pa.—The new dialysis bundled payment system has started to change a number of key areas in the management of secondary hyperparathyroidism in the dialysis setting, seemingly in an effort to save costs, according to a new report from BioTrends Research Group. ...More
May 26, 2011
Posted in News, Business, Clinical & Pharma, Government & Regulation
KAI Starts Secondary Hyperparathyroidism Drug Study

SOUTH SAN FRANCISCO, Calif.—KAI Pharmaceuticals has started to enroll the first patients in a Phase 2 study of KAI-4169, a novel pharmaceutical agent being tested for the treatment of secondary hyperparathyroidism (SHPT). ...More
March 17, 2011
Posted in News, Clinical & Pharma
Cytochroma Starts Phase 2B Study of Vitamin D Capsules

MARKHAM, Ontario—Cytochroma has started a repeat-dose safety and efficacy study of CTAP101 Capsules in patients with vitamin D insufficiency, secondary hyperparathyroidism (SHPT) and stage 3 chronic kidney disease (CKD). ...More
February 17, 2011
Posted in News, Clinical & Pharma
Teva, Barr Can't Sell Generic Sensipar

THOUSAND OAKS, Calif.—Teva Pharmaceuticals and Barr Laboratories will not be able to sell generic versions of Amgen’s Sensipar after a U.S. District Court in Delaware granted an injunction last week. ...More
January 10, 2011
Posted in News, Business, Government & Regulation
FDA Approves Hectorol Vial Dosing Option

CAMBRIDGE, Mass.—The U.S. Food and Drug Administration (FDA) has approved a 2 mcg/mL vial dosing option of Hectorol (doxercalciferol injection), for the treatment of secondary hyperparathyroidism in patients with CKD on dialysis, according to a Dec. 22 news release. ...More
December 22, 2010
Posted in News, Clinical & Pharma, Government & Regulation
KAI Starts of Phase 1b Study Secondary Hyperparathyroidism Drug

SOUTH SAN FRANCISCO, Calif.—KAI Pharmaceuticals announced Sept. 27 that it has started to enroll the first patients in a Phase 1b study of KAI-4169, a novel pharmaceutical agent being tested for the treatment of secondary hyperparathyroidism (SHPT). ...More
September 27, 2010
Posted in News, Clinical & Pharma
FDA Tentatively Approves Generic Sensipar

JERUSALEM—The U.S. Food and Drug Administration has tentatively approved a generic form of Sensipar, according to a May 14 press release from the generic drug’s manufacturer Teva Pharmaceuticals. ...More
May 17, 2010
Posted in News, Business, Clinical & Pharma
Obesity May Affect Kidneys Differently in Whites, Blacks

NEW YORK—Obese African-Americans may be more vulnerable to the effects of chronic kidney disease than obese whites, according to new findings from the National Kidney Foundation’s Kidney Early Evaluation Program (KEEP). ...More
March 1, 2010
Posted in News, Business, Clinical & Pharma
Genzyme Launches 1 mcg Hectorol Capsules

CAMBRIDGE, Mass.—Genzyme Corp. announced Aug. 10 that it has launched a 1 mcg formulation of Hectorol (doxercalciferol capsules). ...More
August 11, 2009
Posted in News, Business, Clinical & Pharma

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