Tacrolimus News and Research

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Tacrolimus is a drug used to help reduce the risk of rejection by the body of organ and bone marrow transplants.

Veloxis Pharmaceuticals seeks FDA approval to market Envarsus for prevention of organ rejection

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.

30 Dec 2013

Researchers explore ways to overcome transplant rejection

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.

27 Dec 2013

U.S. FDA grants Veloxis Orphan Drug status for Envarsus

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.

24 Dec 2013

Bortezomib reduces GVHD, boosts survival for patients receiving stem-cell 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.

9 Dec 2013

Merck announces approval of NOXAFIL delayed-release tablets by FDA

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.

27 Nov 2013

FDA approves OLYSIO (simeprevir) for treatment of chronic hepatitis C infection

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.

23 Nov 2013

FDA accepts Merck's NOXAFIL IV solution NDA for priority review

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.

18 Nov 2013

Novel combination anti-psoriasis therapy targets genetic abnormalities in deeper layers of the skin

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.

15 Nov 2013

Results announced for Phase 3B/4 study of RAPAMUNE in kidney transplant patients

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.

12 Nov 2013

UC researchers receive FDA grant to study generic tacrolimus in high-risk transplant patients

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.

7 Nov 2013

Study reveals that Medicaid beneficiaries with lupus not following treatment plans

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.

28 Oct 2013

Vanderbilt adds genetic screening for drug tacrolimus to PREDICT program

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.

27 Aug 2013

FDA approves Astellas' ASTAGRAF XL for prophylaxis of organ rejection in kidney transplant 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.

20 Jul 2013

Veloxis seeks EMA approval to market LCP-Tacro for kidney transplant patients

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.

29 Apr 2013

FDA accepts Merck's NDA for NOXAFIL tablets

Merck, known as MSD outside the United States and Canada, today announced that its New Drug Application for an investigational, tablet formulation of the company's antifungal agent, NOXAFIL (posaconazole), has been accepted for review by the U.S. Food and Drug Administration.

11 Apr 2013

Abstracts on Bristol-Myers Squibb's research in liver disease accepted for presentation

Bristol-Myers Squibb Company announced today that 14 abstracts on the Company's research in liver disease have been accepted for presentation at The International Liver CongressTM 2013, the 48th annual meeting of the European Association for the Study of the Liver, in Amsterdam, April 24 - 28.

8 Apr 2013

TSRI scientists identify new drugs for human prion disease

Human diseases caused by misfolded proteins known as prions are some of most rare yet terrifying on the planet—incurable with disturbing symptoms that include dementia, personality shifts, hallucinations and coordination problems.

4 Apr 2013

FDA approves Novartis’ Zortress to prevent organ rejection after liver transplantation in adults

Novartis announced today that the US Food and Drug Administration (FDA) has approved Zortress (everolimus) for the prophylaxis of organ rejection in adult patients receiving a liver transplant.

16 Feb 2013

Delaware District Court rules in favor of Pfizer in RAPAMUNE patent case

Pfizer Inc. said today that the United States District Court for the District of Delaware ruled that Pfizer's patent covering a method for using sirolimus, the active ingredient in RAPAMUNE®, for the inhibition of organ transplant rejection is valid and infringed.

31 Jan 2013

Tacrolimus breast milk transfer concerns allayed

Breastfeeding mothers taking tacrolimus do not pass the immunosuppressant on to their babies when breastfeeding, study results show.

29 Jan 2013