Tacrolimus is a drug used to help reduce the risk of rejection by the body of organ and bone marrow transplants.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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%).
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.
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.
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.
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
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.
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.
The experimental drug belatacept can prevent graft rejection in kidney transplant recipients while better preserving kidney function when compared with standard immunosuppressive drugs, data from two international phase III clinical trials show.
Takeda Global Research & Development Center, Inc., U.S., (TGRD U.S.) announced today that it has initiated a trial to study how dexlansoprazole and several other proton pump inhibitors (PPIs) affect the pharmacokinetics and pharmacodynamics of Plavix (clopidogrel bisulfate) in healthy subjects. Takeda has been evaluating all published data and communications from the U.S. Food and Drug Administration (FDA) regarding the potential risks associated with concomitant use of clopidogrel and PPIs.
Psoriasis, a chronic disease that causes red, raised patches of skin, is increasingly seen as a systemic disease with links to arthritis and cardiovascular disease. The December issue of Mayo Clinic Women's HealthSource provides an overview of this sometimes embarrassing condition, what's known about it and how it's treated.
A drug that has become a mainstay of multiple myeloma treatment may outperform alternative therapies in re-establishing the immune system of patients who have received stem cell transplants from unrelated, partially matched donors, according to early clinical trial results to be presented by Dana-Farber Cancer Institute investigators at the American Society of Hematology's (ASH) annual meeting on Sunday, Dec. 6 (Abstract 48, Ernest N. Morial Convention Center, Room 243-245, 5:45 pm CT).