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.
Organ Rejection Prophylaxis
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…
Underused Drug Combo May Up Survival in Lung Transplant
No antibody induction therapy with sirolimus plus tacrolimus associated with maximal survival
Jakafi Approved for Steroid-Refractory Acute Graft-Versus-Host Disease
The FDA has approved Jakafi (ruxolitinib; Incyte) for treatment of steroid-refractory acute graft-versus-host disease (GVHD) in adult and pediatric patients ≥12 years old.
Envarsus XR Approved for New de novo Indication
Veloxis announced that the Food and Drug Administration (FDA) has approved Envarsus XR (tacrolimus extended-release) tablets to prevent organ rejection in de novo kidney transplant patients in combination with other immunosuppressants.
Cannabidiol Gets Orphan Drug Status for Preventing Ischemia-Reperfusion Injury
The designation was granted to Revive Therapeutics, a company that specializes in cannabis-based pharmaceuticals.
Posttransplant Outcomes Assessed in Patients Who Resumed TNFi Therapy
Of the 5256 patients who received a renal transplant in the study window (1/1/1998 – 12/31/2017), 14 met inclusion criteria.
