Azathioprine Discontinuation Up for Patients With CC Genotype
Patients with rs2814778-CC also have lower last leukocyte count and lower dosing; findings persist after adjustment for race
Organ Rejection Prophylaxis
CellCept Approval Expanded to Include Pediatric Recipients of Heart, Liver Transplants
The expanded approval was based on pediatric extrapolation of efficacy from adequate and well-controlled studies and pharmacokinetic data in adult heart transplant and liver transplant patients.
In Breakthrough Transplant, Man Receives Genetically Modified Pig Heart
The Maryland heart patient is still doing well three days after the procedure was performed
Doctors Report That Kidney Grown in Pig Worked in a Human
Kidney came from pig genetically engineered to grow an organ with a low risk for being rejected by the human body
Prograf Approved to Prevent Organ Rejection in Lung Transplantation
The approval was based on an observational study using real-world data collected on all lung transplants in the US.
FDA: More Data on Remestemcel-L for Graft Versus Host Disease Needed
In the CRL, the FDA recommended that the Company conduct at least 1 additional randomized, clinical study.
Inolimomab BLA Submitted for Graft Versus Host Disease
The BLA submission includes data from a phase 3 study comparing inolimomab to antithymocyte globulin in 100 adults with steroid-refractory aGvHD.
Tacrolimus Inhalation Powder Gets Orphan Drug Status for Organ Rejection Prophylaxis
The FDA has granted Orphan Drug Designation to Tacrolimus Inhalation Powder (TFF Pharmaceuticals) for prophylaxis of lung allograft rejection.
Remestemcel-L Under Review for Steroid-Refractory Acute Graft Versus Host Disease
The FDA has accepted for Priority Review the Biologics License Application for remestemcel-L (RyoncilTM; Mesoblast Limited) for the treatment of children with steroid-refractory acute graft versus host disease (SR-aGVHD).
Certain Blister Packages of Sandimmune, Neoral Not Child Resistant
Certain blister packages of Sandimmune (cyclosporine capsules) and Neoral (cyclosporine capsules) may not meet child-resistant packaging requirements, according to manufacturer Novartis. The Company announced that it is working with the Consumer Product Safety Commission to address the packaging issue. In a press statement, Novartis stressed that there are no quality or efficacy issues with the…
