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Statins does not reduce death risk in high-risk individuals without heart disease

A meta-analysis of previously published studies finds no evidence that statins are associated with a reduced risk of death among individuals at risk for but with no history of cardiovascular disease, according to a report in the June 28 issue of Archives of Internal Medicine, one of the JAMA/Archives journals

29 Jun 2010

AMAG, Takeda provide regulatory and clinical update for Feraheme Injection

AMAG Pharmaceuticals, Inc. and Takeda Pharmaceutical Company Limited today provided a regulatory and clinical update for Feraheme® (ferumoxytol) Injection for intravenous (IV) use.

29 Jun 2010

Tranzyme reports positive results from TZP-102 Phase 2 study in diabetic patients with gastroparesis

Tranzyme Pharma announced positive top-line results today from a Phase 2, double-blind, placebo-controlled study evaluating TZP-102 capsules in diabetic patients with gastroparesis, a serious disorder characterized by the inability of the stomach to empty food efficiently. The study achieved a clinically meaningful and statistically significant improvement in critical gastroparesis-related symptoms. All three TZP-102 doses tested were effective, safe and well tolerated.

29 Jun 2010

Dapagliflozin in addition to insulin improves glycemic control in type 2 diabetics

Results from a 24-week Phase 3 clinical study demonstrated that the addition of the investigational drug dapagliflozin achieved reductions in the primary endpoint, glycosylated hemoglobin level (HbA1c), in inadequately controlled type 2 diabetes patients who were treated with insulin (with or without oral anti-diabetes medications (OADs)), compared to placebo plus insulin (with or without OADs).

29 Jun 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

Astellas presents ASP1941 selective SGLT2 inhibitor Phase 2 study results at 70th ADA

Astellas Pharma Inc. announced that the company presented results from a Japanese Phase 2 study conducted with ASP1941, a selective SGLT2 inhibitor, at the 70th Scientific Sessions of the American Diabetes Association (ADA) on June 26, 2010 (EST). ASP1941 is designed to block the re-absorption of glucose in the kidney and excrete glucose in the urine.

29 Jun 2010

MGH, Iacocca Foundation complete Phase I BCG clinical trial in type 1 diabetes

Massachusetts General Hospital (MGH) and the Iacocca Foundation announce today the completion of the Phase I BCG clinical trial in type 1 diabetes, as well as the submission of all safety reports to the U.S. Food and Drug Administration (FDA) and the MGH data safety monitoring boards. Plans for the Phase II clinical study, which will continue the investigation of bacillus Calmette-Guerin (BCG) vaccination as a treatment for people with existing type 1 diabetes, are actively underway.

29 Jun 2010

BioAlliance Pharma presents abstracts on Loramyc, clonidine Lauriad at MASCC/ISOO 2010 symposium

BioAlliance Pharma SA, a company dedicated to the supportive care and treatment of cancer patients, has presented 2 abstracts on Loramyc® and clonidine Lauriad® at the MASCC/ISOO 2010 International Symposium (Vancouver, June 24-26, 2010). These two products belong to the supportive care pipeline of BioAlliance Pharma.

29 Jun 2010

Forest Laboratories, Gedeon Richter report positive results from radiprodil Phase II study for DPNP pain

Forest Laboratories, Inc. and Gedeon Richter Plc. today announced top-line results from a Phase II placebo and positive comparator-controlled, parallel-arm, double-blind, dose-response clinical trial of the novel, investigational NR2B-selective NMDA (N-methyl D-aspartate) receptor antagonist, radiprodil (RGH-896), for the treatment of neuropathic pain associated with diabetic peripheral neuropathy (DPNP).

29 Jun 2010

Zeria reports positive results from Japanese Phase III study of Z-338 for functional dyspepsia

Zeria Pharmaceutical announced today positive results of their Japanese Phase III study of Z-338 (acotiamide hydrochloride hydrate; "acotiamide") for the treatment of functional dyspepsia (FD). FD is a gastrointestinal disease comprised of subjective symptoms including postprandial fullness, early satiation and epigastric pain without any organic abnormality on gastrointestinal tract.

28 Jun 2010

Clinical study results show no increased risk of CV events associated with SYMLIN injection

Amylin Pharmaceuticals, Inc. today announced results from an analysis of an integrated database of clinical studies that showed no increased risk of cardiovascular events associated with SYMLIN (pramlintide acetate) injection use compared to a pooled comparator group treated with either placebo or rapid-acting insulin. These findings were presented at the 70th Annual Scientific Sessions of the American Diabetes Association in Orlando, Fla.

28 Jun 2010

First placebo-controlled clinical study results of BYETTA injection with Lantus presented at ADA 2010

Amylin Pharmaceuticals, Inc. and Eli Lilly and Company today announced results from the first double-blind, placebo-controlled clinical study to evaluate BYETTA (exenatide) injection added to Lantus (insulin glargine), which showed patients with type 2 diabetes achieved glucose targets without weight gain or increasing their risk of hypoglycemia. These findings were presented at the 70th Annual Scientific Sessions of the American Diabetes Association in Orlando, Fla.

28 Jun 2010

Tolerx initiates confirmatory Phase 3 clinical trial to evaluate otelixizumab in new-onset type 1 diabetes

Tolerx, Inc., a biopharmaceutical company developing novel therapies to treat autoimmune diseases and cancer by modulating T cell activity, today announced the initiation of a confirmatory Phase 3 clinical trial to further evaluate otelixizumab in autoimmune new-onset type 1 diabetes. The confirmatory Phase 3 clinical trial is called DEFEND-2 (Durable-Response Therapy Evaluation For Early or New-Onset Type 1 Diabetes) and immediately follows successful completion of enrollment in the initial Phase 3 clinical trial, DEFEND-1, with results from DEFEND-1 expected in the first half of 2011.

28 Jun 2010

ADVANCE study provides new insights into the management of SHPT in CKD patients

Results from the ADVANCE study presented in a late breaking clinical trial session at the ERA-EDTA 2010 Congress provide new insights into the management of secondary hyperparathyroidism in chronic kidney disease patients. ADVANCE (A randomiseD VAscular calcificatioN study to evaluate the effects of CinacalcEt) is a randomised, controlled open label study to evaluate the effects of treatment with Mimpara (cinacalcet) plus low-dose vitamin D, compared to flexible doses of vitamin D alone, on the progression of vascular and valvular calcification in dialysis patients with SHPT.

28 Jun 2010

Linagliptin mono- and combination therapy improves blood glucose control

Linagliptin phase III data were presented for the first time this week at the 70th Scientific Sessions of the American Diabetes Association (ADA), showing that this investigational compound, a dipeptidyl peptidase (DPP)-4 inhibitor, achieved significant, sustained and clinically meaningful reductions in blood glucose as measured by haemoglobin A1c (HbA1c), fasting plasma glucose (FPG), and postprandial glucose (PPG) concentrations.(1-6) Linagliptin is being investigated by Boehringer Ingelheim as a once-daily oral treatment in type 2 diabetes.

28 Jun 2010

Orexigen Therapeutics announces data from CORDiabetes trial for Contrave

Orexigen Therapeutics, Inc. today announced data from the CORDiabetes trial for Contrave (naltrexone sustained release (SR)/bupropion SR) showing that after 56 weeks of treatment, overweight or obese patients with type 2 diabetes lost significantly more weight and achieved greater improvement in glycemic control than those treated with placebo.

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

Arena's lorcaserin reduces body weight across patient subgroups

Arena Pharmaceuticals, Inc. today reported pooled Week 52 data from more than 6,000 patients in lorcaserin's pivotal Phase 3 clinical trial program that demonstrate lorcaserin 10 mg dosed twice daily reduced body weight in all patient subgroups evaluated, as defined by gender, age, ethnicity and starting body weight and Body Mass Index (BMI). Greater improvements in cardiovascular risk factors were also achieved with lorcaserin treatment compared to placebo overall and in most subgroups.

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

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

Placebo News and Research

Statins does not reduce death risk in high-risk individuals without heart disease

AMAG, Takeda provide regulatory and clinical update for Feraheme Injection

Tranzyme reports positive results from TZP-102 Phase 2 study in diabetic patients with gastroparesis

Dapagliflozin in addition to insulin improves glycemic control in type 2 diabetics

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

Astellas presents ASP1941 selective SGLT2 inhibitor Phase 2 study results at 70th ADA

MGH, Iacocca Foundation complete Phase I BCG clinical trial in type 1 diabetes

BioAlliance Pharma presents abstracts on Loramyc, clonidine Lauriad at MASCC/ISOO 2010 symposium

Forest Laboratories, Gedeon Richter report positive results from radiprodil Phase II study for DPNP pain

Zeria reports positive results from Japanese Phase III study of Z-338 for functional dyspepsia

Clinical study results show no increased risk of CV events associated with SYMLIN injection

First placebo-controlled clinical study results of BYETTA injection with Lantus presented at ADA 2010

Tolerx initiates confirmatory Phase 3 clinical trial to evaluate otelixizumab in new-onset type 1 diabetes

ADVANCE study provides new insights into the management of SHPT in CKD patients

Linagliptin mono- and combination therapy improves blood glucose control

Orexigen Therapeutics announces data from CORDiabetes trial for Contrave

EVISTA improves bone quality as measured by HRpQCT: IIT

Arena's lorcaserin reduces body weight across patient subgroups

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

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

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

Evaluating new approaches for rare disease genomics

Expanding access to NMR with the Fourier 80 Duo

Advancing Intracellular Delivery with LumiPore®

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