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UPA: An effective non-invasive treatment for fibroids can help maintain fertility in women

A new, effective, non-surgical treatment for uterine fibroids can help women with this condition maintain their fertility, an American scientist told the 26th annual meeting of the European Society of Human Reproduction and Embryology in Rome today (Wednesday).

30 Jun 2010

European Congress of Nephrology unveils results of various clinical trials

The 47th ERA-EDTA/DGfN congress in Munich has been the setting for a wide range of new clinical data. The results of the following clinical trials were presented at "Late-Breaking Clinical Trials Sessions."

30 Jun 2010

Ph II data of perifosine + capecitabine in metastatic CRC to be presented at gastrointestinal cancer congress

Keryx Biopharmaceuticals, Inc. today announced that abstract O-0017, entitled "Subset Analysis of 5-FU Refractory Patients from a Randomized Ph II Study of Perifosine + Capecitabine (P-CAP) vs. Placebo + Capecitabine (CAP) in Patients with 2nd or 3rd Line Metastatic CRC" has been selected for oral presentation at the upcoming 12th World Congress on Gastrointestinal Cancer, to be held in Barcelona, Spain from June 30 - July 2, 2010.

30 Jun 2010

Alnylam receives Portuguese, Swedish, British approvals to initiate ALN-TTR01 Phase I study in ATTR

Alnylam Pharmaceuticals, Inc., a leading RNAi therapeutics company, announced today that its applications for ALN-TTR01 have been given clearance by Portuguese, Swedish, and British regulatory authorities to begin clinical testing. The trial will begin enrolling patients shortly in a blinded, randomized, placebo-controlled, multicenter Phase I study.

29 Jun 2010

Chelsea initiates NORTHERA Phase III trial for symptomatic NOH associated with PD

Chelsea Therapeutics International, Ltd. announced the initiation of Study 306, a pivotal Phase III trial evaluating the efficacy of NORTHERA™, an oral synthetic precursor of norepinephrine, for the treatment of symptomatic neurogenic orthostatic hypotension (NOH) associated with Parkinson's disease.

29 Jun 2010

Aeterna Zentaris receives positive Scientific Advice from EMA for perifosine Phase 3 trial in colorectal cancer

Aeterna Zentaris Inc., a late-stage drug development company specialized in oncology and endocrine therapy, today announced that it has received positive Scientific Advice from the European Medicines Agency (EMA) regarding the Phase 3 trial initiated last April for the development of its lead anticancer proprietary compound, perifosine, in refractory advanced colorectal cancer.

29 Jun 2010

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

Placebo News and Research

UPA: An effective non-invasive treatment for fibroids can help maintain fertility in women

European Congress of Nephrology unveils results of various clinical trials

Ph II data of perifosine + capecitabine in metastatic CRC to be presented at gastrointestinal cancer congress

Alnylam receives Portuguese, Swedish, British approvals to initiate ALN-TTR01 Phase I study in ATTR

Chelsea initiates NORTHERA Phase III trial for symptomatic NOH associated with PD

Aeterna Zentaris receives positive Scientific Advice from EMA for perifosine Phase 3 trial in colorectal cancer

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

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