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.
Organ Rejection Prophylaxis
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.
Adverse Effect of Osteoporosis Drug May Help Treat Hair Loss
Researchers found that a non-immunosuppressant drug originally designed to treat osteoporosis (WAY-316606) targeted the same mechanism by antagonizing SFRP1, and after treating hair follicles with WAY-316606 for 6 days, the authors found enhanced human hair growth.
Envarsus XR sNDA Seeking New Indication Submitted to FDA
In the study, Envarsus XR proved non-inferior to immediate-release tacrolimus as seen by treatment failure rates.
