Content about Dialysis

March 11, 2014

Prasco Laboratories announced on Tuesday that it has started shipping the generic version of Hectorol (doxercalciferol) 0.5-, 1.0- and 2.5-mcg capsules, each in 50-count bottles under the Prasco label.

CINCINNATI — Prasco Laboratories announced on Tuesday that it has started shipping the generic version of Hectorol (doxercalciferol) 0.5-, 1.0- and 2.5-mcg capsules, each in 50-count bottles under the Prasco label.

Prasco entered into a distribution and supply agreement with Genzyme, a Sanofi company, for doxercalciferol capsules, the generic version of Hectorol 0.5-, 1.0- and 2.5-mcg capsules.
 

February 18, 2014

Roxane Labs on Tuesday announced the introduction of doxercalciferol capsules, available in strengths of 0.5-mcg, 1-mcg, and 2.5-mcg in 50-count bottles for immediate shipment to wholesalers and pharmacies across the nation.

COLUMBUS, Ohio — Roxane Labs on Tuesday announced the introduction of doxercalciferol capsules, available in strengths of 0.5-mcg, 1-mcg, and 2.5-mcg in 50-count bottles for immediate shipment to wholesalers and pharmacies across the nation.  

Doxercalciferol is used to lower elevated parathyroid hormone levels in patients who undergo kidney dialysis. Roxane Labs’ doxercalciferol capsules is AB Rated in the Food and Drug Administration Orange Book to Hectorol (doxercalciferol) capsules, 0.5-mcg, 1-mcg, and 2.5-mcg.

February 6, 2014

Sandoz announced the launch of doxercalciferol injection vials, the first generic version of Genzyme’s Hectorol.

PRINCETON, N.J. — Sandoz announced the launch of doxercalciferol injection vials, the first generic version of Genzyme’s Hectorol. Doxercalciferol injection vials are used for the treatment of secondary hyperparathyroidism in patients with chronic kidney disease on dialysis.

“Sandoz is pleased to be the first company to market a high quality, affordable generic version of this important product to dialysis patients in the US,” Peter Goldschmidt, President of Sandoz, said.  

August 8, 2013

Keryx Biopharmaceuticals announced the submission of a new drug application to the Food and Drug Administration seeking approval for the marketing and sale of Zerenex (ferric citrate coordination complex), the company's drug candidate for the treatment of elevated serum phosphorus levels, or hyperphosphatemia, in patients with chronic kidney disease on dialysis.

NEW YORK — Keryx Biopharmaceuticals, Inc., today announced the submission of a new drug application to the U.S. Food and Drug Administration seeking approval for the marketing and sale of Zerenex (ferric citrate coordination complex), the company's drug candidate for the treatment of elevated serum phosphorus levels, or hyperphosphatemia, in patients with chronic kidney disease on dialysis.

July 16, 2013

Diplomat Specialty Pharmacy is supporting a summer camp for children with chronic kidney disease, the company said Tuesday.

FLINT, Mich. – Diplomat Specialty Pharmacy is supporting a summer camp for children with chronic kidney disease, the company said Tuesday.

Diplomat said it would support the National Kidney Foundation of Michigan's 27th consecutive Kid's Camp in Fenton, Mich., which started Sunday and lasts through Friday.

September 4, 2012

Generic drug maker Impax Labs has settled with a subsidiary of Sanofi regarding generic versions of two drugs for dialysis patients, Impax said Tuesday.

HAYWARD, Calif. — Generic drug maker Impax Labs has settled with a subsidiary of Sanofi regarding generic versions of two drugs for dialysis patients, Impax said Tuesday.

Impax announced a settlement with Genzyme concerning generic versions of Renvela (sevelamer carbonate) 800 mg tablets and 2.4 g and 0.8 g oral suspension and Renagel (sevelamer hydrochloride) tablets in the 400 mg and 800 mg strengths.

April 10, 2012

Biotech manufacturer Amgen will acquire the private South San Francisco, Calif.-based drug developer Kai Pharmaceuticals for $315 million, the companies said Tuesday.

THOUSAND OAKS, Calif. — Biotech manufacturer Amgen will acquire the private South San Francisco, Calif.-based drug developer Kai Pharmaceuticals for $315 million, the companies said Tuesday.

The deal includes the acquisition of KAI-4169, an experimental drug Kai is developing for secondary hyperparathyroidism in patients with chronic kidney disease who are on dialysis. Amgen has provided a loan to fund phase-3 clinical studies of the drug and will acquire rights to it worldwide, except for Japan.

January 12, 2012

Active Health Foods has introduced an energy bar designed for dialysis patients.

RIVERSIDE, Calif. — Active Health Foods has introduced an energy bar designed for dialysis patients.

The Active X double chocolate chip bar is made with an exclusive, proprietary formula and joins the company's current lineup of energy bars sold under the Active X and Active X Plus brands.

January 11, 2012

Fleming Pharmaceuticals has sold rights of several of its products to Valeant International, Fleming said Wednesday.

ST. LOUIS — Fleming Pharmaceuticals has sold rights of several of its products to Valeant International, Fleming said Wednesday.

Fleming announced the sale of the OTC nasal spray Ocean, the prescription kidney dialysis vitamin supplement Nephrocaps, the magnesium supplement Magonate and ProBarimin QT, a medical food product for patients who have received weight loss surgery. Financial terms were not disclosed.

June 3, 2011

The gold standard long-term glucose monitoring test for patients with diabetes proved to be of limited value in dialysis patients, according to a new study at Wake Forest Baptist Medical Center released Wednesday.

WINSTON-SALEM, N.C. — The gold standard long-term glucose monitoring test for patients with diabetes proved to be of limited value in dialysis patients, according to a new study at Wake Forest Baptist Medical Center released Wednesday.

March 7, 2011

Late-stage clinical trial data for a Keryx Biopharmaceuticals drug to treat kidney disease will be presented at a medical conference in Las Vegas.

NEW YORK — Late-stage clinical trial data for a Keryx Biopharmaceuticals drug to treat kidney disease will be presented at a medical conference in Las Vegas.

Keryx said Monday that phase-3 data for the drug Zerenex (ferric citrate), a drug for abnormally high phosphate levels in patients with end-stage kidney disease on dialysis, will be presented at the upcoming National Kidney Foundation spring clinical meetings in April.

The company announced “positive” results from a phase-3 trial of the drug in November.

February 8, 2011

The Food and Drug Administration has given expedited review to a drug for preventing hemodialysis failure in patients with end-stage kidney disease.

CAMBRIDGE, Mass. — The Food and Drug Administration has given expedited review to a drug for preventing hemodialysis failure in patients with end-stage kidney disease.

The FDA granted fast-track review status to the cell-based therapy Vascugel, made by Pervasis Therapeutics. The FDA grants the status to accelerate review of treatments for serious and life-threatening conditions, particularly those that address serious, unmet medical conditions.

December 1, 2010

Drug maker Keryx Biopharmaceuticals got promising results from a late-stage clinical trial of a drug for treating elevated phosphate levels, also known as hyperphosphatemia, in patients on kidney dialysis, the company said Tuesday.

NEW YORK — Drug maker Keryx Biopharmaceuticals got promising results from a late-stage clinical trial of a drug for treating elevated phosphate levels, also known as hyperphosphatemia, in patients on kidney dialysis, the company said Tuesday.

In a phase-3 trial, Zerenex (ferric citrate) significantly reduced phosphate levels in patients with end-stage kidney disease on dialysis.

October 25, 2010

Drug maker Keryx Biopharmaceuticals has finished enrolling participants for a late-stage clinical trial of a...

NEW YORK Drug maker Keryx Biopharmaceuticals has finished enrolling participants for a late-stage clinical trial of a drug for patients on kidney dialysis, Keryx said Tuesday.

 

The company is conducting a phase-3 trial of Zerenex (ferric citrate) in patients with end-stage kidney disease on dialysis who have excessive phosphorous levels, a condition known as hyperphosphatemia.

 

 

Keryx said it expects to complete the study and report top-line data by the end of the year.

 

September 28, 2010

Keryx has begun its phase-3 clinicial trial of a drug designed to treat elevated serum...

NEW YORK Keryx has begun its phase-3 clinicial trial of a drug designed to treat elevated serum phosphorous levels in patients with end-stage renal disease on dialysis.

July 5, 2010

Generic drug maker Impax Labs is challenging the patent on a drug used to treat...

May 5, 2010

Keryx Biopharmaceuticals has started a late-stage clinical trial of a drug for patients on kidney...