Organ Rejection Prophylaxis
The designation was granted to Revive Therapeutics, a company that specializes in cannabis-based pharmaceuticals.
Of the 5256 patients who received a renal transplant in the study window (1/1/1998 - 12/31/2017), 14 met inclusion criteria.
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.
For this review, researchers performed an extensive literature search for studies and cases where an adverse drug reaction occurred likely due to an interaction between an herbal and a prescribed medicine.
Tepadina, an alkylating agent, is indicated to reduce the risk of graft rejection when used with high-dose busulfan and cyclophosphamide as a preparative regimen for allogeneic hematopoietic progenitor (stem) cell transplantation (HSCT) for pediatric patients with class 3 beta-thalassemia.
Thymoglobulin was originally approved for the treatment of renal transplant acute rejection in 1998. It is available as single-use 10mL vials containing 25mg of anti-thymocyte globulin as a lyophilized powder.
Researchers have successfully grown human stem cells in pig embryos, setting in motion a path of research which could lead to human organs being grown in animals for the purpose of transplantation.
The prospect of human stem cells developing in an animal's brain also becomes a possibility, raising serious ethical dilemmas that go to the core of what it is to be human.
Veloxis announced that the Food and Drug Administration (FDA) has approved updates to the Envarsus XR (tacrolimus extended-release tablets) labeling regarding pharmacokinetics (PK) and pharmacogenomics (PG) data from the ASERTAA trial.
AbbVie announced that the Food and Drug Administration (FDA) has granted a fourth Breakthrough Therapy designation for Imbruvica (ibrutinib) and an Orphan Drug designation for the potential treatment of chronic graft-versus-host-disease (cGVHD) after failure of one or more lines of systemic therapy.
Mycophenolate mofetil appears safe and effective for the treatment of autoimmune hepatitis (AIH), according to the results of a study published in Alimentary Pharmacology & Therapeutics.
Veloxis announced that Envarsus XR (tacrolimus extended-release) tablets are now available for the prophylaxis of rejection in kidney transplant patients converted from immediate-release tacrolimus formulations, in combination with other immunosuppressants.
The FDA has granted Fast Track designation to Cinryze (C1 esterase inhibitor [human]; Shire) as an adjunct to Donor Specific Antibodies (DSA) reduction therapy in renal transplant patients with acute Antibody Mediated Rejection (AMR).
Veloxis announced that the Food and Drug Administration (FDA) has approved Envarsus XR (tacrolimus extended-release) tablets for the prophylaxis of rejection in kidney transplant patients who require or desire conversion from other twice-daily tacrolimus products to once-daily Envarsus XR.
Bristol-Myers Squibb Company announced results from the Phase 3 BENEFIT trial in kidney transplant patients receiving Nulojix (belatacept) vs. cyclosporine.
Generic formulations of tacrolimus were found to be just as good as the brand Prograf (Astellas) version, researchers from the University of Cincinnati have found.
The Food and Drug Administration (FDA) has granted Orphan Drug designation to Glassia (alpha1-proteinase inhibitor [human]) for the treatment of Graft-versus-host disease (GVHD).
Plexison announced that the Food and Drug Administration (FDA) has approved Pleximmune, a first-in-class blood test to predict acute cellular rejection of transplanted livers and intestines in children.
Pre-liver transplant (LTx) hyponatremia does not affect post-LTx survival, but hypernatremia is a significant risk factor for post-LTx mortality.
The FDA has granted Orphan Drug designation to Soliris (eculizumab; Alexion), a first-in-class terminal complement inhibitor for the prevention of delayed graft function (DGF) in renal transplant patients.
Veloxis announced the submission of a New Drug Application (NDA) to the FDA for Envarsus (tacrolimus; formerly LCP-Tacro) for prophylaxis of organ rejection in patients receiving allogenic kidney transplants.
The FDA has granted Orphan Drug designation to Envarsus (tacrolimus; Veloxis) for prophylaxis of organ rejection in patients receiving allogenic kidney transplants.