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Last updated on April 24, 2014 at 21:24 EDT

Latest Tacrolimus Stories

2013-01-03 08:23:25

HORSHOLM, Denmark, Jan. 3, 2013 /PRNewswire/ -- Veloxis Pharmaceuticals A/S today is announcing that the LCP-Tacro Phase III clinical trial in stable kidney transplant patients, the 3001 study, has been published online in the American Journal of Transplantation. The article reports on the randomized, controlled, multicenter Phase III trial, which demonstrated that LCP-Tacro dosed once-daily was not inferior to the current leading transplant drug, Prograf(®), dosed twice-daily....

2012-12-11 12:01:29

An experimental drug combination for preventing graft-versus-host disease (GVHD) was not significantly better than the standard regimen on key endpoints, according to a report of a phase 3 trial at the American Society of Hematology annual meeting. The combination of two immunosuppressive compounds -- tacrolimus plus sirolimus -- did not provide a statistically significant, GVHD-free survival benefit over the long-used standard of care, tacrolimus plus methotrexate, said researchers from...

2012-12-06 08:28:06

HORSHOLM, Denmark, Dec. 6, 2012 /PRNewswire/ -- Veloxis Pharmaceuticals A/S (OMX: VELO) today announced results of a preliminary analysis from the first 16 patients in its Switching STudy of Kidney TRansplant PAtients with Tremor to LCP-TacrO (STRATO) clinical trial. Results from the first 16 patients demonstrated a trend toward a reduction in tremor following the switch from twice-daily tacrolimus to once-daily LCP-Tacro. "Tremor is a common side effect of tacrolimus administration and it...

2012-12-04 16:26:55

NORTHBROOK, Ill., Dec. 4, 2012 /PRNewswire/ -- Astellas Pharma US, Inc. ("Astellas"), a U.S. subsidiary of Tokyo-based Astellas Pharma Inc. (Tokyo: 4503), announced today that the U.S. Food and Drug Administration (FDA) has accepted for review the company's New Drug Application (NDA) for tacrolimus extended release capsules, for the prophylaxis of organ rejection in adult kidney transplant recipients and adult male liver transplant recipients. Based upon the September receipt of the NDA...

2012-11-02 11:25:50

BOSTON, Nov. 2, 2012 /PRNewswire/ -- Late-breaking Oral SessionMonday, November 12, 2012 - 3:00-4:30 pmAuditorium, Hynes Convention Center The six abstracts that will be presented at our late-breaking oral session relate to new therapies for patients with chronic liver diseases. Four of the six studies (see numbers 1 - 4 below) report on the results of oral therapy for the treatment of hepatitis C, a disease that affects more than 3 million Americans and that is currently...

2012-10-10 07:28:02

HORSHOLM, Denmark, Oct. 10, 2012 /PRNewswire/ -- Veloxis will give two upcoming data presentations that further define the profile of LCP-Tacro compared to other tacrolimus formulations. The first study demonstrates the potentially flexible dosing that may improve dosing convenience for transplant patients. A second study demonstrates the enhanced bioavailability of tacrolimus driven by LCP-Tacro's proprietary formulation, compared to another once-daily tacrolimus formulation, which could...

2012-10-05 02:23:20

HORSHOLM, Denmark, Oct. 5, 2012 /PRNewswire/ -- Veloxis Pharmaceuticals A/S (OMX: VELO) today announced that it has entered into an exclusive distribution agreement with Chiesi Farmaceutici S.p.A, a fully integrated European Pharmaceutical company focused on respiratory disease and special care products, for the commercialization and distribution of its novel formulation immunosuppressant drug candidate LCP-Tacro in certain countries, including Europe, Turkey and CIS countries. Under...

2012-09-24 06:26:59

NORTHBROOK, Ill., Sept. 24, 2012 /PRNewswire/ -- Astellas Pharma US, Inc. ("Astellas"), a U.S. subsidiary of Tokyo-based Astellas Pharma Inc. (Tokyo: 4503), today announced it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) seeking approval for tacrolimus extended release capsules for the prophylaxis of organ rejection in adult kidney transplant recipients and adult male liver transplant recipients. Developed by Astellas, tacrolimus...

2012-05-31 10:24:42

In the news release, Veloxis Pharmaceuticals to Present Results from a Patient Subgroup Analysis of Once-Daily LCP-Tacro(TM) in Stable African-American Kidney Transplant Patients at American Transplant Congress (ATC), issued 31-May-2012 by Veloxis Pharmaceuticals A/S over PR Newswire, we are advised by the company that the end of the second paragraph should read "second quarter of 2013" rather than "second quarter of 2012" as originally issued inadvertently. The complete, corrected release...

2012-05-31 06:28:23

HORSHOLM, Denmark, May 31, 2012 /PRNewswire/ -- Veloxis Pharmaceuticals A/S (OMX: VELO) today announced that a subgroup analysis of African-American stable kidney transplant patients enrolled in Study 3001, a Phase 3 non-inferiority study, suggests that these patients may be safely converted from twice-daily Prograf(®) to once-daily LCP-Tacro. In addition, there was a trend toward fewer biopsy-proven acute rejections (BPARs) with LCP-Tacro compared to Prograf. The analysis will be...