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Raptor initiates enrollment in pivotal Phase 3 clinical trial of DR Cysteamine for nephropathic cystinosis

Raptor Pharmaceutical Corp. announced that it has enrolled the first patient in a pivotal Phase 3 clinical trial of its proprietary delayed-release oral formulation of cysteamine bitartrate ("DR Cysteamine") in patients with nephropathic cystinosis ("cystinosis").

28 Jun 2010

EMA CHMP recommends marketing approval of BRINAVESS for conversion of recent onset AF to sinus rhythm

Merck and Cardiome Pharma Corp. today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended marketing approval for BRINAVESS® (vernakalant), an investigational intravenous (IV) formulation for the conversion of recent onset atrial fibrillation (AF) to sinus rhythm in adults.

28 Jun 2010

Final results of VIAject vs. RHI Phase 3 study in type 2 diabetes patients presented at 70th ADA

The final results of a six-month, multi-center, open-label Phase 3 study of VIAject® (more-rapid-acting injectable human insulin) versus regular human insulin (RHI) in 471 patients with type 2 diabetes were presented today by Helena Rodbard, M.D., at the 70th Scientific Sessions of the American Diabetes Association. Dr. Rodbard was a principal investigator of this study, which was designed to evaluate the safety and efficacy of VIAject® versus regular human insulin when used in combination with insulin glargine.

28 Jun 2010

EVISTA improves bone quality as measured by HRpQCT: IIT

Interim data from a prospective Investigator Initiated Trial presented today at the ECTS, the 37th European Symposium on Calcified Tissues, in Glasgow, demonstrates that EVISTA (raloxifene 60mg; once-daily, distributed in 34 countries by DAIICHI SANKYO), indicated for the treatment and prevention of osteoporosis in postmenopausal women, improves bone quality as measured by the high-resolution peripheral quantitative computed tomography.

28 Jun 2010

St. Mary Medical Center opens new outpatient center for chronic wound treatment

High Desert residents suffering from hard-to-heal wounds now have greater resources to help heal their wounds and get their lives back. St. Mary Medical Center, a 190-bed acute care hospital in the High Desert of Southern California, announced today the opening of its Center for Wound Care and Hyperbaric Medicine.

28 Jun 2010

Medtronic initiates enrollment in ASPIRE study of MiniMed Paradigm x54 Low Glucose Suspend integrated system

Demonstrating its dedication to close the loop for diabetes management, Medtronic, Inc. today announced that the first patient has been enrolled as part of the ASPIRE study of the MiniMed Paradigm x54 System featuring Low Glucose Suspend automation. Low Glucose Suspend works by automatically suspending insulin delivery temporarily if blood glucose levels become too low as defined by the patient and his or her healthcare provider and is a feature available commercially in Medtronic's Paradigm® Veo™ System in more than 35 countries outside of United States.

28 Jun 2010

Tolerx presents preclinical data on TRX518 anti-GITR immunotherapy for cancer

Tolerx, Inc., a biopharmaceutical company developing novel therapies to treat autoimmune diseases and cancer by modulating T cell activity, presented results from preclinical studies with TRX518, an early-stage agent Tolerx is developing as a treatment for cancer. TRX518 is a monoclonal antibody to glucocorticoid-induced tumor necrosis factor receptor (GITR) and is designed to enhance the immune system's ability to attack tumors by activating and rendering T effector cells resistant to T regulatory cell suppression.

28 Jun 2010

TRL commences operations at San Diego facility with focus on biological drugs for autoimmune diseases

Tanabe Research Labs USA, Inc. (TRL) today announced commencement of its new operations at the TRL facility in San Diego with a focus on biological drugs for the treatment of autoimmune diseases. TRL began its new activities in May with the appointment of three new senior executives: Masaki Yamada, Ph.D., Chief Executive Officer; Toshihiro Hosaka, Ph.D., Senior Vice President, and Roland Newman, Ph.D., VP and Chief Scientific Officer.

28 Jun 2010

Poster presentation at MASCC Conference summarizes MuGard clinical experience

ACCESS PHARMACEUTICALS, INC., a biopharmaceutical company specializing in products for cancer and supportive care, is presenting a scientific poster today at the Multinational Association of Supportive Care in Cancer Conference in Vancouver, B.C. The poster presentation, co-authored by Dr. David Nowotnik of Access Pharmaceuticals and Dr. Caroline Dumas of SpePharm Holdings, summarizes MuGard clinical experience from cancer patients globally undergoing radiotherapy and/or chemotherapy.

28 Jun 2010

Phase 2 proof-of-concept data for Novo Nordisk's degludec presented at ADA 2010

Novo Nordisk today presented phase 2 proof-of-concept data for its investigational insulin degludec, an ultra-long-acting basal insulin, which demonstrated the potential to help achieve target glycemic control when used once daily or three times weekly. These data were presented at the 70th Scientific Sessions of the American Diabetes Association.

28 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

Lantus and Apidra injections improve glycemic control, reduce hospital complications: Study

Sanofi-aventis announced today that results from the RAndomized Study of Basal Bolus Insulin Therapy in the Inpatient Management of Patients with Type 2 Diabetes Undergoing General Surgery (RABBIT-2 Surgery) found that treatment with a basal-bolus regimen that included Lantus (insulin glargine [rDNA origin] injection) once-daily and Apidra (insulin glulisine [rDNA origin] injection) before meals improved glycemic control and reduced hospital complications, compared to "sliding scale" insulin in general surgery patients with type 2 diabetes.

28 Jun 2010

Hospital for Special Surgery announces receipt of $5M commitment from CA Technologies

Hospital for Special Surgery announced the receipt of a $5 million commitment from CA Technologies, an IT management software and solutions company, at its 27th Annual Tribute Dinner at the Waldorf Astoria on June 21, 2010.

28 Jun 2010

Phase III clinical trials: Linagliptin achieves significant, sustained reductions in blood sugar

Data from four pivotal Phase III clinical trials demonstrate that linagliptin achieved statistically significant and sustained reductions in blood sugar as measured by hemoglobin A1c, fasting plasma glucose and postprandial glucose. Boehringer Ingelheim Pharmaceuticals, Inc. is investigating the dipeptidyl peptidase 4 inhibitor as an oral once-daily tablet, as monotherapy and combination therapy, to treat type 2 diabetes.

28 Jun 2010

Antioxidant therapy may prevent long-lasting cognitive impairment in cerebral malaria: Research

Using an experimental mouse model for malaria, an international group of scientists has discovered that adding antioxidant therapy to traditional antimalarial treatment may prevent long-lasting cognitive impairment in cerebral malaria. Their findings were published online June 24, 2010, in the journal PLoS Pathogens.

28 Jun 2010

VPRIV receives positive opinion from CHMP for treatment of type 1 Gaucher disease

Shire plc, the global specialty biopharmaceutical company, announced today that the Committee for Medicinal Products for Human Use of the European Medicines Agency adopted a positive opinion on the marketing authorisation for VPRIV (velaglucerase alfa), the company's enzyme replacement therapy for the treatment of type 1 Gaucher disease.

28 Jun 2010

Genomic analysis leads to more effective diagnostic tests, treatment options for prostate cancer: Study

A unique collaboration among physician-scientists at Memorial Sloan-Kettering Cancer Center has yielded the most comprehensive genomic analysis of prostate cancer to date. "Genomic studies in other cancer types have resulted in new drug targets and strategies to classify patients into clinically meaningful subgroups that improve treatment decisions," said senior study author Charles Sawyers, Chair of the Human Oncology and Pathogenesis Program at MSKCC and a HHMI investigator. "This first -ever database of its type brings us one step closer to achieving that goal in prostate cancer."

28 Jun 2010

Antiviral therapy prevents recurrence of HCC, extends patients' lives, researchers report

Previous studies have shown that antiviral treatment reduces the incidence of hepatocellular carcinoma in patients with chronic hepatitis B. But now, researchers from the Division of Gastroenterology and Hepatology at Thomas Jefferson University are reporting that the antiviral therapy also prevents recurrence of HCC and extends patients' lives.

25 Jun 2010

Athersys, CSCRM and CWRU receive $1M to advance MultiStem therapy for SCI

Athersys, Inc. and its collaborators, including the Center for Stem Cell and Regenerative Medicine and Case Western Reserve University, announced today that they have been awarded $1 million through the Ohio Third Frontier Biomedical Program to support research into the treatment of spinal cord injury with MultiStem, Athersys' proprietary stem cell product candidate.

25 Jun 2010

Prescription Solutions introduces Clinical Vantage to improve health and well-being of members

Prescription Solutions, a leading pharmacy benefit management organization and a UnitedHealth Group company, has launched Clinical Vantage, a suite of clinical programs that enables clients to create specialized solutions to meet their particular needs to improve the health and well-being of members.

25 Jun 2010

Therapy News and Research

Raptor initiates enrollment in pivotal Phase 3 clinical trial of DR Cysteamine for nephropathic cystinosis

EMA CHMP recommends marketing approval of BRINAVESS for conversion of recent onset AF to sinus rhythm

Final results of VIAject vs. RHI Phase 3 study in type 2 diabetes patients presented at 70th ADA

EVISTA improves bone quality as measured by HRpQCT: IIT

St. Mary Medical Center opens new outpatient center for chronic wound treatment

Medtronic initiates enrollment in ASPIRE study of MiniMed Paradigm x54 Low Glucose Suspend integrated system

Tolerx presents preclinical data on TRX518 anti-GITR immunotherapy for cancer

TRL commences operations at San Diego facility with focus on biological drugs for autoimmune diseases

Poster presentation at MASCC Conference summarizes MuGard clinical experience

Phase 2 proof-of-concept data for Novo Nordisk's degludec presented at ADA 2010

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

Lantus and Apidra injections improve glycemic control, reduce hospital complications: Study

Hospital for Special Surgery announces receipt of $5M commitment from CA Technologies

Phase III clinical trials: Linagliptin achieves significant, sustained reductions in blood sugar

Antioxidant therapy may prevent long-lasting cognitive impairment in cerebral malaria: Research

VPRIV receives positive opinion from CHMP for treatment of type 1 Gaucher disease

Genomic analysis leads to more effective diagnostic tests, treatment options for prostate cancer: Study

Antiviral therapy prevents recurrence of HCC, extends patients' lives, researchers report

Athersys, CSCRM and CWRU receive $1M to advance MultiStem therapy for SCI

Prescription Solutions introduces Clinical Vantage to improve health and well-being of members

Event guide: 4th Extra-Hepatic Lipid-Based Nanoparticles Delivery Summit eBook

Advancing Neuroscience Research Through Collaboration and Patient-Centered Innovation

The impact of vibration on microscopy

How Omics Technologies Are Transforming Biological Research and Drug Discovery

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