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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

Roche reports results of 5 taspoglutide Phase III studies for type 2 diabetes at 70th ADA

Ipsen a global biopharmaceutical group, today announced that its partner Roche disclosed results of five Phase III 24-week studies for taspoglutide for type 2 diabetes at the American Diabetes Association's (ADA) 70th Annual Scientific Sessions. Taspoglutide, the first once weekly glucagon-like peptide-1 (GLP-1) analogue based on a human sequence, originating from Ipsen's research is developed by Roche. This compound is similar to the natural hormone GLP-1 which has a key role in blood sugar regulation.

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

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

Report: Health information technology could result in harm to patients without proper monitoring

Health information technology could inadvertently result in harm to patients without proper monitoring, according to a new report by The Leapfrog Group, an employer-backed health advocacy organization.

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

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

Data on MetAP2 inhibitors for treatment of obesity presented at ADA 2010

Zafgen, Inc., a pharmaceutical company pioneering novel obesity therapeutics to help the body regain and sustain a lean, healthy state by targeting imbalances in fat metabolism, today announced data on ZGN-201, a prototype methionine aminopeptidase 2 inhibitor, for the treatment of obesity. Preclinical studies demonstrate MetAP2 inhibition eliminates excess body weight through the regulation of fat metabolism and food intake, and normalizes glucose tolerance in animal models.

28 Jun 2010

Phase 2b clinical trial data of SGLT2 inhibitor in patients with type 2 diabetes presented at ADA 2010

Johnson & Johnson Pharmaceutical Research & Development, L.L.C. announced today that canagliflozin, an investigational, oral, selective sodium-glucose transporter-2 inhibitor, improved glycemic control, and was also associated with a decrease in body weight, in a Phase 2b dose-ranging trial in patients diagnosed with type 2 diabetes who were concurrently treated with metformin. The data were presented at the 70th American Diabetes Association Scientific Sessions.

28 Jun 2010

Japan's MHLW grants full marketing authorization to REVLIMID

Celgene International Sàrl announced that REVLIMID (lenalidomide) has been granted full marketing authorization by Japan's Ministry of Health, Labour and Welfare for use in combination with dexamethasone as a treatment for patients with relapsed or refractory multiple myeloma who have received at least one prior standard therapy. This marketing authorization represents the first regulatory approval of REVLIMID in Japan.

25 Jun 2010

Research provides hope and encouragement to people living with lupus

Research presented during the 9th International Lupus Congress held in Vancouver, Canada from June 24-27, 2010 should give hope and encouragement for the future of the treatment and management of lupus to the 1.5 million Americans and 5 million people worldwide living with lupus. In recent years, there have been significant advances made in many areas of lupus research including the development of new treatments, adult stem cell transplantation, genetics, lupus-related cardiovascular disease, and quality of life issues for people with lupus.

25 Jun 2010

CorMedix announces dosing of first patient with CRMD-001 in Phase II clinical trial

CorMedix Inc., a pharmaceutical company focused on developing and commercializing therapeutic products for the prevention and treatment of Cardiorenal disease, today announced dosing of the first patient with CRMD-001 (a proprietary formulation of deferiprone) in a randomized, double-blind, placebo-controlled clinical trial.

25 Jun 2010

CHMP adopts positive opinion on pending MAA for SYCREST sublingual tablets

Merck announced that the Committee for Medicinal Products for Human Use adopted a positive opinion on the pending Marketing Authorization Application for SYCREST (asenapine) sublingual tablets. The CHMP has recommended that the European Commission grant a marketing authorization for SYCREST for the treatment of moderate to severe manic episodes associated with bipolar I disorder in adults. The CHMP did not support an indication for the treatment of schizophrenia.

25 Jun 2010

Investment report on Somaxon Pharmaceuticals

MicroStockProfit.com announces an investment report featuring Somaxon Pharmaceuticals Inc. The report includes financial, comparative and investment analyses, and industry information you need to know to make an educated investment decision.

25 Jun 2010

Two experimental drugs have potential to restore pumping strength to failing hearts, study finds

We've all experienced the strong heartbeat that accompanies emotions such as fear and rage. But can the body's natural response to these emotions be used to combat heart failure? Results of a study published online today in the journal Circulation Research present a strong case.

25 Jun 2010

Quark Pharmaceuticals' siRNA drug candidates featured in two presentations at Glaucoma & Retinopathies 2010

Quark Pharmaceuticals, Inc., a world leader in the discovery and development of RNAi-based therapeutics, today announced that two of its siRNA drug candidates were featured in the following two presentations at the Glaucoma & Retinopathies 2010 conference, which was held June 21-22, 2010 in London, UK.

25 Jun 2010

Phase 2 clinical trial of GMI-1070 for treatment of vaso-occlusive crisis of sickle cell disease initiated

GlycoMimetics, Inc., a clinical-stage biotechnology company developing a new class of glycobiology-based therapies for a broad range of indications, today announced the commencement of a Phase 2 clinical trial of GMI-1070 for treatment of vaso-occlusive crisis of sickle cell disease. The company also announced that GMI-1070 has received Fast Track designation from the U.S. Food and Drug Administration.

25 Jun 2010

Cardio-respiratory aerobic exercise reduces joint pain in RA patients

Researchers from the University of Grenoble Medical School in France determined that cardio-respiratory aerobic exercise is safe for patients with stable rheumatoid arthritis (RA).

25 Jun 2010

Merck's DULERA Inhalation Aerosol for asthma receives FDA approval

Merck today announced that the U.S. Food and Drug Administration (FDA) has approved DULERA® (mometasone furoate and formoterol fumarate dihydrate) Inhalation Aerosol, a new fixed-dose combination asthma treatment for patients 12 years of age and older. DULERA is not indicated for the relief of acute bronchospasm. DULERA combines an inhaled corticosteroid (mometasone furoate) with a long-acting beta2-agonist (formoterol fumarate).

24 Jun 2010

Efficacy News and Research

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

Roche reports results of 5 taspoglutide Phase III studies for type 2 diabetes at 70th ADA

EVISTA improves bone quality as measured by HRpQCT: IIT

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

Report: Health information technology could result in harm to patients without proper monitoring

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

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

Data on MetAP2 inhibitors for treatment of obesity presented at ADA 2010

Phase 2b clinical trial data of SGLT2 inhibitor in patients with type 2 diabetes presented at ADA 2010

Japan's MHLW grants full marketing authorization to REVLIMID

Research provides hope and encouragement to people living with lupus

CorMedix announces dosing of first patient with CRMD-001 in Phase II clinical trial

CHMP adopts positive opinion on pending MAA for SYCREST sublingual tablets

Investment report on Somaxon Pharmaceuticals

Two experimental drugs have potential to restore pumping strength to failing hearts, study finds

Quark Pharmaceuticals' siRNA drug candidates featured in two presentations at Glaucoma & Retinopathies 2010

Phase 2 clinical trial of GMI-1070 for treatment of vaso-occlusive crisis of sickle cell disease initiated

Cardio-respiratory aerobic exercise reduces joint pain in RA patients

Merck's DULERA Inhalation Aerosol for asthma receives FDA approval

Achieving and maintaining ISO/IEC 27001 and BS 10012 certifications

Expanding research and clinical options for children with cancer

Examining how pain could play a direct protective role in the gut

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