Cyclosporine News and Research

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Cyclosporine is a drug used to help reduce the risk of rejection of organ and bone marrow transplants by the body. It is also used in clinical trials to make cancer cells more sensitive to anticancer drugs.

International study to improve treatments for Duchenne muscular dystrophy

A large international study aimed at improving the care of muscular dystrophy patients worldwide is being launched by physicians, physical therapists, and researchers at the University of Rochester Medical Center.

3 Sep 2010

FDA approves Novartis' Tekamlo for treatment of high blood pressure

The US Food and Drug Administration (FDA) approved Tekamlo™ (aliskiren and amlodipine) tablets, a single-pill for the treatment of high blood pressure combining the only approved direct renin inhibitor, Tekturna® (aliskiren), with the widely used calcium channel blocker amlodipine. Tekamlo is approved as initial therapy for patients who are likely to need multiple drugs to achieve their blood pressure goals, and as replacement therapy for patients whose blood pressure is not adequately controlled with either aliskiren or amlodipine alone.

27 Aug 2010

Inspire Pharmaceuticals, Allergan sign amended agreement for ophthalmic formulations

Inspire Pharmaceuticals, Inc. announced today it has entered into an Amended and Restated License, Development and Marketing Agreement with Allergan, Inc., which revises terms related to the PROLACRIA (diquafosol tetrasodium ophthalmic solution) 2% development program and Inspire's right to receive revenues from Allergan based on net sales of RESTASIS (cyclosporine ophthalmic emulsion) 0.05% and any other human ophthalmic formulations of cyclosporine owned or controlled by Allergan.

25 Aug 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

Inspire second-quarter total revenue increases 18% to $27.3 million

Inspire Pharmaceuticals, Inc. announced today financial results for the second quarter ended June 30, 2010, reporting a net loss of $8.8 million or ($0.11) per share, an improvement from the second quarter of 2009 during which the Company incurred a net loss of $9.5 million or ($0.17) per share.

5 Aug 2010

Endo Pharmaceuticals total revenues for second-quarter 2010 increase 6% to $396.5 million

Endo Pharmaceuticals today reported financial results for the second quarter 2010. Total revenues during the second quarter of 2010 increased 6 percent to $396.5 million, compared with $373.1 million in the same quarter of 2009. Net income for the three months ended June 30, 2010 was $51.5 million, compared with $30.0 million in the comparable 2009 period.

30 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

Welchol plus metformin combination therapy reduces A1C, LDL-C levels in type 2 diabetes patients

Results of a new study demonstrated that initial combination therapy with Welchol® (colesevelam HCl) 3.75 g/d and metformin (initiated at 850 mg/d; uptitrated to 1700 mg/d thereafter) significantly improved glycemic and lipid control in drug-naive adult type 2 diabetes patients with high LDL cholesterol (LDL-C).

29 Jun 2010

JANUMET results in greater blood sugar reductions in patients with type 2 diabetes compared to pioglitazone

New data were presented at the American Diabetes Association 70th Annual Scientific Sessions from a study comparing JANUMET (sitagliptin/metformin) to pioglitazone. In this study, JANUMET resulted in significantly greater blood sugar reductions in patients with type 2 diabetes compared with pioglitazone.

28 Jun 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

LIVALO for primary hyperlipidemia or mixed dyslipidemia now available in U.S.

Kowa Pharmaceuticals America, Inc., and Eli Lilly and Company today announced that LIVALO® (pitavastatin) tablets is now available in retail pharmacies throughout the United States. LIVALO, a statin medication approved by the U.S. Food and Drug Administration (FDA) in August 2009 is indicated for adults as an adjunctive therapy to diet for the treatment of primary hyperlipidemia or mixed dyslipidemia. LIVALO is available in doses of 1 mg, 2 mg and 4 mg.

21 Jun 2010

Inspire's TIGER-1 Phase 3 clinical trial data with denufosol for CF presented at 33rd ECFS

Inspire Pharmaceuticals, Inc. announced today that data is being presented on denufosol tetrasodium, an investigational therapy for cystic fibrosis (CF), during an oral presentation and poster presentations at the 33rd Annual European Cystic Fibrosis Society (ECFS) Conference June 16 - 19, 2010 in Valencia, Spain.

18 Jun 2010

First clinical trial results of XOMA 052 in patients with uveitis of Behcet's disease presented at EULAR 2010

XOMA Ltd., a leader in the discovery and development of therapeutic antibodies, announced positive results from an open-label pilot study of XOMA 052 in patients with uveitis of Behcet's disease who were suffering from vision-threatening exacerbations despite maximal doses of immunosuppressive medicines.

17 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

Scientists present data on denufosol tetrasodium for CF at ATS 2010 International Conference

Inspire Pharmaceuticals, Inc. announced today that Inspire scientists and collaborators will present data on denufosol tetrasodium, an investigational therapy for cystic fibrosis, during an oral presentation at the American Thoracic Society 2010 International Conference May 14 - 19, 2010 in New Orleans, LA.

20 May 2010

Sanofi-aventis commences multinational Phase IIIb PALLAS trial of Multaq in permanent AF patients

Sanofi-aventis announced today the initiation of a multinational, randomized double-blind Phase IIIb trial, PALLAS, to assess the potential clinical benefit of Multaq(R) (dronedarone) in over 10, 000 patients with permanent atrial fibrillation (AF) to reduce major adverse cardiovascular events. The announcement was made during Heart Rhythm 2010, the Heart Rhythm Society's 31st Annual Scientific Sessions.

12 May 2010

Argos Therapeutics announces presentations on sCD83 protein capabilities at 2010 American Transplant Congress

Argos Therapeutics today announced two oral presentations detailing data on its soluble CD83 (sCD83) protein program at the 2010 American Transplant Congress, held May 1-5 in San Diego. The data, which were produced by Argos in collaboration with scientists from the University of Western Ontario, demonstrate that sCD83 is capable of inducing immune system tolerance to transplant grafts and suppressing an anti-donor antibody response, via a multi-faceted mechanism-of-action that impacts B and T cells, as well as dendritic cells.

5 May 2010

Inspire Pharmaceuticals reports net loss of $14.8M for first-quarter 2010

Inspire Pharmaceuticals, Inc. announced today financial results for the first quarter ended March 31, 2010, reporting a net loss of $14.8 million or ($0.18) per share.

3 May 2010