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.

Smoking withdrawal after liver transplantation may protect against neoplasia development

Spanish researchers have found that liver transplant recipients who quit smoking have a lower incidence of smoking-related malignancies than patients who keep smoking.

30 Mar 2011

Smoking cessation after liver transplantation reduces incidence of malignancy

Spanish researchers have found that liver transplant recipients who quit smoking have a lower incidence of smoking-related malignancies (SRM) than patients who keep smoking. In fact, SRMs were identified in 13.5% of deceased patients and smoking was associated with a higher risk of malignancy in this study. Full findings are published in the April issue of Liver Transplantation, a journal of the American Association for the Study of Liver Diseases.

29 Mar 2011

Variation in exposure to sunlight may affect sensitivity of individuals to drugs

A study from the Swedish medical university Karolinska Institutet has shown that the body's ability to break down medicines may be closely related to exposure to sunlight, and thus may vary with the seasons.

9 Mar 2011

Astellas' Protopic receives Health Canada approval for prevention of eczema flares

Astellas Pharma Canada, Inc. has announced that it has received approval from Health Canada for a new indication for its topical eczema therapy, Protopic® (tacrolimus ointment 0.03% and 0.1%). The new indication means that tacrolimus ointment can be prescribed for maintenance therapy to prevent flares and prolong flare free intervals in patients with moderate to severe atopic dermatitis (commonly called eczema).

17 Feb 2011

U.S. FDA clears QMS Everolimus Immunoassay to prevent rejection in kidney transplants

The U.S. Food and Drug Administration today announced that it has cleared a test to help manage potential organ rejection in kidney transplant patients. The test, called QMS Everolimus Immunoassay, monitors the blood level of everolimus, a drug that helps prevent rejection in kidney transplants.

14 Feb 2011

Positive results from LifeCycle Pharma's LCP-Tacro comparative trial in de novo liver transplant patients

LifeCycle Pharma A/S has announced positive top-line results from a Phase 2 clinical trial involving 58 patients comparing LCP-Tacro™ tablets administered once-daily versus Prograf® (tacrolimus) capsules (Astellas Pharma) administered twice-daily in de novo liver transplant patients for one year.

7 Jan 2011

Agensys and Seattle Genetics initiate ASG-5ME phase I clinical trial for castration-resistant prostate cancer

Agensys, Inc., an affiliate of Tokyo-based Astellas Pharma Inc., and Seattle Genetics, Inc. today announced that they have initiated a phase I clinical trial of ASG-5ME for the treatment of castration-resistant prostate cancer. ASG-5ME is an antibody-drug conjugate (ADC) targeting the SLC44A4 antigen and is being co-developed by both companies for the treatment of solid tumors.

21 Oct 2010

BARACLUDE sNDA receives FDA approval for treatment of CHB patients with decompensated liver disease

Bristol-Myers Squibb Company announced today that the U.S. Food and Drug Administration (FDA) has approved the supplemental New Drug Application (sNDA) of BARACLUDE for the treatment of chronic hepatitis B (CHB) in adult patients with decompensated liver disease.

18 Oct 2010

Bristol-Myers, Otsuka launch My SPRYCEL Support program to assist patients with CML

Bristol-Myers Squibb Company and Otsuka Pharmaceutical Co., Ltd. today announced the launch of My SPRYCEL (dasatinib) Support, a useful resource to assist adult patients with chronic myeloid leukemia (CML) who are taking SPRYCEL.

15 Oct 2010

'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