News

STRATO study of LCP-Tacro (Veloxis Pharmaceuticals) shows benefits for Kidney Transplant patients

Data from the STRATO study demonstrates the potential for LCP-Tacro (tacrolimus once daily), from Veloxis Pharmaceuticals, to improve tacrolimus-induced tremors in stable Kidney Transplant patients. In this open-label trial, 44 kidney transplant patients who were stable on twice-daily tacrolimus and had a complaint of hand tremor were switched to once-daily LCP-Tacro. Tremor was evaluated using the FTM scale and by ...

FDA approves Zortress (Novartis)for prophylaxis of organ rejection in Liver Transplant patients

Novartis announced that the FDA has, on 15 February 2013 ,approved Zortress (everolimus) for the prophylaxis of organ rejection in adult patients receiving a Liver Transplant.

Zortress is the first mammalian target of rapamycin (mTOR) inhibitor approved for use following Liver Transplantation. It is also the first immunosuppressant approved by the FDA in over a decade for use following ...

Phase III study of LCP-Tacro (Veloxis Pharmaceuticals) shows drug is non-inferior to current treatment in Kidney Transplant patients

New data on the 3001 Study of LCP-Tacro, from Veloxis Pharmaceuticals, in stable Kidney Transplant patients has been published. This randomized, controlled, multicenter Phase III trial demonstrated that LCP-Tacro dosed once-daily was not inferior to the current leading transplant drug, Prograf, dosed twice-daily. Results demonstrated that patients can be successfully converted from twice-daily Prograf to once-daily LCP-Tacro, which may increase ...

Phase II study of RiaSTAP (CSL Behring) shows the drug has benefits in Critical Care patients

Clinical study results show that RiaSTAP (fibrinogen concentrate [human]), from CSL Behring, can significantly reduce the need for blood transfusion when given in a Critical Care situation, as an intra-operative, targeted first-line hemostatic therapy in bleeding patients undergoing aortic replacement surgery. The Phase II prospective study, led by Niels Rahe-Meyer of the Clinic for Anesthesiology and Intensive Care Medicine, at ...

Two year results of Certican (Novartis ) in Liver Transplant rejection confirm superiority over tacrolimus

Novartis announced new two-year results from the largest Phase III study ever in Liver Transplantation that confirmed comparable efficacy to control and superior renal function results previously seen at 12 months. The trial evaluated the introduction of Certican (everolimus) with reduced exposure tacrolimus administered twice-daily starting one month after liver transplantation versus standard-exposure tacrolimus.

At 24 months, the incidence ...

Astellas submits NDA for Advagraf for prophylaxis of Organ Rejection

Astellas Pharma US has submitted a New Drug Application (NDA) to the FDA seeking approval for Advagraf (tacrolimus extended release capsules) for the prophylaxis of Organ Rejection in adult kidney transplant recipients and adult male liver transplant recipients. The NDA submission is based on six randomized and comparative studies of 2,842 (1,689 tacrolimus extended release) kidney transplant recipients and 689 ...

Phase II results positive for Prochymal (Osiris Therapeutics)following Myocardial Infarction

A Phase II, multi-center, randomized, double-blind, placebo-controlled study is evaluating the safety and efficacy of Prochymal (ex-vivo cultured adult human mesenchymal stem cells) intravenous infusion from Osiris Therapeutics, following acute myocardial infarction. A total of 220 patients were randomized (1:1) at 33 centers in the United States and Canada and received a single intravenous infusion of Prochymal or placebo within ...

Health Canada approves Prochymal (Osiris Therapeutics) for Graft-v-Host Disease in children

Canadian health regulators have approved Prochymal, from Osiris Therapeutics, for acute Graft-v-Host Disease in children who are not responding to steroid therapy, making it the first stem cell drug to be approved for a systemic disease anywhere in the world. Prochymal was authorized under Health Canada's Notice of Compliance with conditions (NOC/c) pathway, which provides access to therapeutic products that ...

New study for Architect Tacrolimus assay (Abbott Diagnostics)

A new study published in the journal Clinical Chemistry reported Architect Tacrolimus assay from Abbott Diagnostics provides accurate and consistent medication monitoring for patients taking tacrolimus, an immunosuppressive medication, after receiving solid organ transplantation. This study showed tacrolimus values were not comparable between laboratories and across methods, but the Architect assay was close to the target values and comparable from ...