Content about Biopharmaceuticals

February 28, 2013
Outlook for biosimilars remains cloudy

Biosimilar medicines have been approved and routinely prescribed in Europe for nearly seven years, and creation of a clear pathway for Food and Drug Administration review and approval of generic versions of bioengineered drugs was enshrined into law in the United States with the passage of the Patient Protection and Affordable Care Act nearly three years ago.

Biosimilar medicines have been approved and routinely prescribed in Europe for nearly seven years, and creation of a clear pathway for Food and Drug Administration review and approval of generic versions of bioengineered drugs was enshrined into law in the United States with the passage of the Patient Protection and Affordable Care Act nearly three years ago. But IMS Health and other industry experts agree it could still be years before biosimilars are available to pharmacies and patients in this country.

October 31, 2012
Sandoz starts phase-3 trial of biosimilar anemia drug

Generic drug maker Sandoz has started a late-stage clinical trial in the United States for a biosimilar treatment for anemia, the company said.

HOLZKIRCHEN, Germany — Generic drug maker Sandoz has started a late-stage clinical trial in the United States for a biosimilar treatment for anemia, the company said.

Sandoz, the generics arm of Swiss drug maker Novartis, said it had started enrolling patients for a phase-3 study of epoetin alfa, a biosimilar version of Epogen and Procrit, made by Amgen and Johnson & Johnson and used to treat anemia associated with chronic kidney disease.

June 7, 2012
Perrigo wins approval for renal failure drug

The Food and Drug Administration has approved a drug for kidney disease made by Perrigo.

ALLEGAN, Mich. — The Food and Drug Administration has approved a drug for kidney disease made by Perrigo.

Perrigo announced the approval of calcium acetate capsules, a generic version of Nabi Biopharmaceuticals' Phoslo Gelcaps. The drug is used to treat end-stage renal failure.

Perrigo settled a patent infringement lawsuit concerning the drug last year, though terms of the settlement were not disclosed. Annual sales of the branded version of the drug and generic versions were $95 million, according to Wolters Kluwer Health.

April 18, 2011
Keryx, Torii commence phase-3 trial for Zerenex in Japan

A U.S. drug maker and its Japanese partner have started a late-stage clinical trial of a drug for treating elevated phosphate levels in the body, the two announced Monday.

NEW YORK — A U.S. drug maker and its Japanese partner have started a late-stage clinical trial of a drug for treating elevated phosphate levels in the body, the two announced Monday.

Keryx Biopharmaceuticals and Torii Pharmaceutical, the pharmaceuticals subsidiary of Japan Tobacco, started a phase-3 trial of Zerenex (ferric citrate) in Japan for patients with hyperphosphatemia. The drug also is in phase-3 trials in the United States as a treatment for hyperphosphatemia in patients with end-stage kidney disease on dialysis.

March 7, 2011
Keryx to present phase-3 clinical data for Zerenex at conference

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.

December 1, 2010
Keryx: Zerenex reduces phosphate levels in patients on kidney dialysis

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
Keryx to commence phase-3 trial for Zerenex

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.

 

August 9, 2010
GSK to pay Nabi third milestone for PentaStaph

Nabi Biopharmaceuticals will receive an $8 million payment from British drug maker GlaxoSmithKline following a...