Content about Transplantation medicine

December 10, 2012

Astellas Pharma US has announced the Food and Drug Administration's approval to review the new drug application for tacrolimus extended-release capsules.

NORTHBROOK, Ill. — Astellas Pharma US announced the Food and Drug Administration's review of their new drug application for tacrolimus extended-release capsules, a once-daily formulation of the calcineurin-inhibitor immunosuppressant tacrolimus, for the prophylaxis of organ rejection in adult kidney transplant recipients and adult male liver transplant recipients.

August 13, 2012

An experimental drug therapy under development by Novartis for liver transplant patients appears to provide similar efficacy and better kidney function, compared with a drug made by Astellas Pharma, according to results of a late-stage clinical trial.

EAST HANOVER, N.J. — An experimental drug therapy under development by Novartis for liver transplant patients appears to provide similar efficacy and better kidney function, compared with a drug made by Astellas Pharma, according to results of a late-stage clinical trial.

A phase-3 study published in the American Journal of Transplantation found that patients taking RAD001 (everolimus) with a reduced dose of Astellas' Prograf (tacrolimus) experienced equal efficacy and superior kidney function to patients taking Prograf alone.

April 2, 2012

Two drug makers have finalized the design of a late-stage clinical trial for a vaccine against a common virus that can cause complications later in life.

SAN DIEGO — Two drug makers have finalized the design of a late-stage clinical trial for a vaccine against a common virus that can cause complications later in life.

Vical and Astellas Pharma announced Monday that they had finalized the general design of a phase-3 trial of TransVax, a vaccine against cytomegalovirus, or CMV, for transplant recipients.

June 16, 2011

The Food and Drug Administration has approved a new drug for preventing organ rejection in kidney transplant patients, the agency said Wednesday.

SILVER SPRING, Md. — The Food and Drug Administration has approved a new drug for preventing organ rejection in kidney transplant patients, the agency said Wednesday.

The FDA approved Bristol-Myers Squibb’s Nulojix (belatacept), for preventing acute rejection in adult patients. The drug is approved for use with other immune system-suppressing drugs, specifically Novartis’ Simulect (basiliximab), Genentech’s CellCept (mycophenolate mofetil) and corticosteroids.

September 14, 2010

The Food and Drug Administration has approved new dosing recommendations for children and adolescents using...

WASHINGTON The Food and Drug Administration has approved new dosing recommendations for children and adolescents using a drug for heart and kidney transplants.

 

The agency announced Wednesday the recommendations, designed to prevent overdosing in children taking Genentech’s antiviral Valcyte (valganciclovir), particularly among those of low weight, smaller size and very low serum creatinine.

 

 

August 10, 2010

The Food and Drug Administration is allowing kidney transplant patients to use a drug for...

July 5, 2010

The Food and Drug Administration has approved a drug made by Watson Pharmaceuticals for treating...

May 20, 2010

Dr. Reddy’s Labs has launched a treatment for organ transplant patients, the Indian generic drug...