Tacrolimus is a drug used to help reduce the risk of rejection by the body of organ and bone marrow transplants.
Veloxis Pharmaceuticals A/S and Chiesi Farmaceutici S.p.A. today announced that the European Commission (EC) has granted marketing authorization for Envarsus for the prevention of organ rejection in adult kidney and liver transplant patients in the European Union.
Microorganisms like bacteria and fungi can evade treatment by acquiring mutations in the genes targeted by antibiotics or antifungal drugs.
Boehringer Ingelheim today announced that new data will be presented from 7 abstracts for Gilotrif (afatinib) and investigational compounds, including nintedanib and BI 836845, from its oncology pipeline at the 50th Annual Meeting of the American Society of Clinical Oncology (ASCO) in Chicago, IL, on May 30 – June 3, 2014.
Janssen Research & Development, LLC (Janssen) today announced it has submitted a Supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) for simeprevir, an NS3/4A protease inhibitor marketed as OLYSIO™ in the United States, in combination with the nucleotide analog NS5B polymerase inhibitor sofosbuvir developed by Gilead Sciences, Inc.
Every organ transplant patient in the world faces the potential danger of his/her body rejecting a new organ, such as a heart, kidney or liver. Immunosuppressant drugs are required to help prevent rejection.
Merck, known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration has approved NOXAFIL (posaconazole) injection (18 mg/ mL), a new formulation of NOXAFIL for intravenous (IV) use.
Veloxis Pharmaceuticals A/S, today announced that it has submitted a New Drug Application to the U.S. Food and Drug Administration seeking approval for the marketing and sale of Envarsus (formerly LCP-Tacro) for the prevention of organ rejection in kidney transplant recipients.
Given that 10.5 % of patients who receive a transplant reject the new organ, researchers at the Center of Research and Advanced Studies of the National Polytechnic Institute (Cinvestav) are working in the design of a tool capable of preventing this problem.
Veloxis Pharmaceuticals A/S, today announced that Envarsus was granted Orphan Drug status by the U.S. Food and Drug Administration (FDA) for prophylaxis of organ rejection in patients receiving allogenic kidney transplants.
Adding bortezomib (Velcade) to standard preventive therapy for graft-versus-host-disease (GVHD) results in improved outcomes for patients receiving stem-cell transplants from mismatched and unrelated donors, according to researchers from Dana-Farber Cancer Institute.
Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has approved NOXAFIL® (posaconazole) 100 mg delayed-release tablets.
Janssen Therapeutics, Division of Janssen Products, LP, announced today the U.S. Food and Drug Administration has approved OLYSIO (simeprevir), an NS3/4A protease inhibitor, for the treatment of chronic hepatitis C infection as part of an antiviral treatment regimen in combination with pegylated interferon and ribavirin in genotype 1 infected adults with compensated liver disease, including cirrhosis.
Merck, known as MSD outside the United States and Canada, today announced that its New Drug Application for an investigational intravenous solution formulation of the company's antifungal agent, NOXAFIL (posaconazole), has been accepted for priority review by the U.S. Food and Drug Administration.
A novel combination anti-psoriasis therapy has potential for superior and longer-lasting therapeutic effects than current topical treatments by targeting genetic abnormalities in deeper layers of the skin. This research is being presented at the 2013 American Association of Pharmaceutical Scientists Annual Meeting and Exposition, the world's largest pharmaceutical sciences meeting, in San Antonio, Nov. 10-14.
Pfizer Inc. (NYSE:PFE) announced today top-line results from a Phase 3B/4 study of RAPAMUNE® (sirolimus) evaluating kidney transplant patients who transitioned from tacrolimus-based therapy (TAC) to RAPAMUNE® 3 to 5 months after transplant.
Transplant researchers at the University of Cincinnati have received a grant from the U.S. Food and Drug Administration to study the safety and efficacy of a generic immunosuppressive drug in high-risk transplant patients.
Medicaid beneficiaries with lupus are not adequately following their treatment plans, and this puts them at risk for poor health outcomes, according to research presented this week at the American College of Rheumatology Annual Meeting in San Diego. For most lupus medications, fewer than one in three beneficiaries were found to be adherent.
Vanderbilt has added genetic screening for the drug tacrolimus to its personalize medicine pharmacogenomics program PREDICT. The new drug screening protocol was added following data that shows a single genetic variation largely impacts different dose requirements for patients.
Astellas Pharma US, Inc., a U.S. subsidiary of Tokyo-based Astellas Pharma Inc., announced today that the U.S. Food and Drug Administration has approved ASTAGRAF XLTM (tacrolimus extended-release capsules) for the prophylaxis of organ rejection in patients receiving a kidney transplant with mycophenolate mofetil and corticosteroids, with or without basiliximab induction.
Veloxis Pharmaceuticals A/S today announced that it has submitted a Marketing Authorization Application to the European Medicines Agency seeking approval to market LCP-Tacro for the prevention of organ rejection in kidney transplant patients in the European Union.