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.

'The Pittsburgh Protocol' enables reduction of multiple anti-rejection drugs after transplantation

The Pittsburgh Protocol is unique in utilizing bone marrow cells to enable reduction of the need for multiple anti-rejection drugs after transplantation. The University of Pittsburgh Medical Center is currently the only transplantation center in the world to offer it. An early report of the initial experience with the "Pittsburgh Protocol" in three recipients of upper extremity transplants was presented during the 2010 Annual Clinical Congress of the American College of Surgeons.

7 Oct 2010

FDA approves Mylan's generic Prograf Capsules ANDA

Mylan Inc. today announced that its subsidiary Mylan Pharmaceuticals Inc. has received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Tacrolimus Capsules, 0.5 mg, 1 mg and 5 mg, the generic version of Astellas' Prograf® Capsules, a treatment to prevent rejection in people who have received certain organ transplants.

21 Sep 2010

Agensys commences AGS-16M8F ADC Phase I clinical trial for renal cancer

Agensys, Inc., an affiliate of Tokyo-based Astellas Pharma Inc., today announced that they have initiated a Phase I clinical trial of AGS-16M8F an antibody-drug conjugate (ADC) that is being developed for the treatment of metastatic renal cancer. An ADC uses the specific binding properties of an antibody to target a toxin in tumor cells, resulting in selective tumor cell killing.

2 Sep 2010

3Sbio, Isotechnika Pharma sign development and commercialization agreement for voclosporin inhibitor

Isotechnika Pharma Inc., a biopharmaceutical company focused on the discovery and development of immune modulating therapeutics, and 3SBio Inc., a leading China-based biotechnology company focused on researching, developing, manufacturing and marketing biopharmaceutical products, today announced the signing of a development and commercialization agreement for voclosporin, a next generation calcineurin inhibitor being developed for use in the prevention of organ rejection following transplantation and the treatment of autoimmune diseases.

25 Aug 2010

3SBio and Isotechnika enter strategic agreement for voclosporin in China

3SBio Inc., a leading China-based biotechnology company focused on researching, developing, manufacturing and marketing biopharmaceutical products and Isotechnika Pharma Inc., a biopharmaceutical company focused on the discovery and development of immune modulating therapeutics, today announced the signing of a development and commercialization agreement for voclosporin.

24 Aug 2010

FDA grants LifeCycle Pharma SPA for LCP-Tacro pivotal Phase 3 study in 'de novo' kidney transplant patients

LifeCycle Pharma A/S today announced receipt of agreement with the U.S. Food and Drug Administration on a Special Protocol Assessment of its pivotal Phase 3 study, Study 3002, for LCP-Tacro in patients, who have just received a kidney transplant.

12 Aug 2010

Limerick to announce new results from LIM-0705 human trials at 23rd Transplantation Society congress

Limerick BioPharma, Inc., a developer of innovative therapies that help cells pump out unwanted or toxic substances, will announce new results from human trials of its lead compound, LIM-0705, at the 23rd International Congress of the Transplantation Society in Vancouver, Canada, in an oral presentation on August 19, 2010.

29 Jul 2010

Astellas extends non-exclusive license agreement with Regeneron for VelocImmune technology

Regeneron Pharmaceuticals, Inc. and Astellas Pharma Inc. announced that Astellas has extended through 2023 the non-exclusive license agreement that allows Astellas to utilize Regeneron's VelocImmune® technology in its internal research programs to discover fully human monoclonal antibody product candidates.

28 Jul 2010

Seattle Genetics, Agensys commence ASG-5ME ADC phase I clinical trial for metastatic pancreatic cancer

Seattle Genetics, Inc. and Agensys, Inc., an affiliate of Tokyo-based Astellas Pharma Inc., today announced that they have initiated a phase I clinical trial of ASG-5ME for the treatment of metastatic pancreatic cancer. ASG-5ME is an antibody-drug conjugate (ADC) that is being co-developed by both companies for the treatment of solid tumors.

20 Jul 2010

FDA accepts to review sNDA for SPRYCEL for treating adult patients with CML

Bristol-Myers Squibb Company and Otsuka Pharmaceutical Co., Ltd. today announced that the U.S. Food and Drug Administration has accepted for filing and review the supplemental New Drug Application for SPRYCEL (dasatinib) for the treatment of adult patients with newly diagnosed chronic myeloid leukemia in chronic phase.

12 Jul 2010

Watson Laboratories receives FDA approval for Tacrolimus ANDA

Watson Pharmaceuticals, Inc., today announced that its subsidiary, Watson Laboratories, Inc., has received approval from the United States Food and Drug Administration on its Abbreviated New Drug Application (ANDA) for Tacrolimus 5 mg capsules, the generic equivalent to Astellas' Prograf® capsules.

2 Jul 2010

Cyclosporine treatment develops higher de novo cancer risk in liver transplant patients: Researchers

Researchers at Erasmus MC University Medical Centre in The Netherlands found that cyclosporine treatment is a significant risk factor for the development of de novo cancer in liver transplant patients. Full details appear in the July issue of Liver Transplantation, a journal published by Wiley-Blackwell on behalf of the American Association for the Study of Liver Diseases.

25 Jun 2010

Merck proposes to initiate Phase II proof-of-concept clinical study of posaconazole for chronic Chagas disease

Merck today announced plans to initiate a Phase II investigational proof-of-concept clinical study to evaluate its oral antifungal agent posaconazole for the treatment of chronic Chagas disease. Chagas disease results from infection with the parasite Trypanosoma cruzi that is spread by biting insects. The disease is estimated to affect approximately eight million people in Latin America, of whom approximately 30-40 percent will develop serious cardiac disease, digestive disease, or both as a result of this infection.

24 Jun 2010

Four-year follow-up results from SPRYCEL Phase 3 study in CML-CP presented at ASCO

Bristol-Myers Squibb Company and Otsuka Pharmaceutical Co., Ltd. today announced four-year follow-up results from a Phase 3 randomized, open-label, dose-optimization study of SPRYCEL® (dasatinib) in chronic-phase chronic myeloid leukemia (CML-CP) patients resistant or intolerant to Gleevec®* (imatinib mesylate). At four years, for all patients administered SPRYCEL 100 mg once daily, overall survival was 82% (95% CI: 76%-88%) and progression-free survival was 66% (95% CI: 57%-74%).

9 Jun 2010

Dr. Reddy's Laboratories launches tacrolimus capsules in the US market

Dr. Reddy's Laboratories today announced that it has launched tacrolimus capsules, (0.5mg, 1mg, 5mg), a bioequivalent generic version of Prograf Capsules, in the US market on May 20, 2010. The United States Food & Drug Administration granted an approval of Dr. Reddy's ANDA for tacrolimus capsules on May 13, 2010.

21 May 2010

Belatacept preserves kidney function in transplant recipients better than cyclosporine, says study

Two-year results from phase III clinical trials show the experimental immunosuppressive drug belatacept can better preserve kidney function in kidney transplant recipients while preventing graft rejection when compared with the standard immunosuppressive drug cyclosporine.

3 May 2010

Seattle Genetics, Agensys present ASG-5ME ADC preclinical data at 101st AACR

Seattle Genetics, Inc. and Agensys, Inc., an affiliate of Tokyo-based Astellas Pharma Inc., today reported preclinical data with ASG-5ME, an antibody-drug conjugate (ADC) that is being co-developed by both companies for the treatment of solid tumors. In models of human prostate and pancreatic cancer, ASG-5ME was found to have potent and long lasting antitumor activity. The findings were presented at the 101st Annual Meeting of the American Association for Cancer Research (AACR) being held in Washington, D.C.

22 Apr 2010

Isotechnika Pharma releases fourth quarter financial results; reviews operational and scientific highlights for 2009

Isotechnika Pharma Inc. has released its financial results for the fourth quarter and year ended December 31, 2009 and provided a review of the Company's operational and scientific highlights for 2009

25 Mar 2010

Positive results from Limerick BioPharma's LIM-0705 Phase 1a trial

Limerick BioPharma, Inc., a developer of innovative therapies that help cells pump unwanted or toxic substances away from vulnerable tissues, has announced positive results of a Phase 1a trial for its lead compound, LIM-0705, which has completed its first in man study.

10 Mar 2010

KAPIDEX to be marketed as DEXILANT in the U.S.

Takeda Pharmaceuticals North America, Inc. announced today that KAPIDEX™ (dexlansoprazole) will be marketed in the United States under the new product trade name DEXILANT™ (dexlansoprazole). The product is indicated for heartburn associated with symptomatic non-erosive gastroesophageal reflux disease (GERD), the healing of erosive esophagitis (EE) and the maintenance of healed EE.

5 Mar 2010