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Once-a-day dosing clinical study of udenafil for erectile dysfunction completed

Dong-A Pharmaceutical Co., Ltd. and Dong-A PharmTech, Co. Ltd. announced today that it has completed a 240 patient once-a-day dosing clinical study of udenafil, its new long acting phosphodiesterase type 5 (PDE-5) inhibitor for erectile dysfunction (ED).

19 Nov 2009

Positive results from REVIVE, a phase 3 pivotal study of avanafil announced

VIVUS, Inc. today announced positive results from REVIVE (TA-301), a phase 3 pivotal study evaluating the safety and efficacy of avanafil, an investigational drug candidate for the treatment of erectile dysfunction (ED), in 646 patients.

18 Nov 2009

Phase 2/3 study results of Genzyme's APB announced

Genzyme Corporation today reported results of a phase 2/3 study of its advanced phosphate binder (APB). The trial met its primary endpoint, which was to show that the APB lowered phosphate levels effectively compared to placebo. However, the APB did not show a significant improvement in phosphate lowering compared to Genzyme’s Renvela® (sevelamer carbonate).

18 Nov 2009

Ambrisentan improves health and exercise capacity of PAH patients, find researchers

In one of the few studies of the long-term effects of medication in the treatment of pulmonary arterial hypertension (PAH) disease, a team of researchers found the health and exercise capacity of PAH patients improved after two years of treatment with ambrisentan, according to a study published in the current edition of the Journal of the American College of Cardiology.

18 Nov 2009

CRESTOR reduces major cardiovascular events in women by 46%

A new analysis of the JUPITER trial, released today at the American Heart Association meeting in Orlando, Florida, demonstrates that CRESTOR (rosuvastatin calcium) 20mg reduced first major cardiovascular events by 46%.

18 Nov 2009

Study examines link between folic acid and cancer incidence

Patients with heart disease in Norway, a country with no fortification of foods with folic acid, had an associated increased risk of cancer and death from any cause if they had received treatment with folic acid and vitamin B12, according to a study in the November 18 issue of JAMA.

18 Nov 2009

Sildenafil improves heart function in youngsters with single ventricle congenital heart disease

Heart function significantly improved in children and young adults with single ventricle congenital heart disease who have had the Fontan operation following treatment with sildenafil, a drug used to treat erectile dysfunction and pulmonary hypertension, say researchers from The Children's Hospital of Philadelphia.

18 Nov 2009

Phase 2 clinical trial to test gene therapy treatment for Alzheimer's disease

Mount Sinai School of Medicine is one of 12 sites nationwide participating in the first Phase 2 clinical trial to test gene therapy treatment for Alzheimer's disease. The study is the first multicenter neurosurgical intervention in Alzheimer's research in the U.S.

18 Nov 2009

Phase III randomized clinical trial for Alpharadin to be commenced

International prostate cancer expert Dr. Oliver Sartor of Tulane Cancer Center is the first oncologist in the United States to offer patients an experimental new treatment for late-stage prostate cancer through a multi-center clinical trial that is currently recruiting patients at 100 sites across 20 countries worldwide.

18 Nov 2009

Transplanting people's own stem cells into heart muscle lessens pain and improves ability to walk

The largest national stem cell study for heart disease showed the first evidence that transplanting a potent form of adult stem cells into the heart muscle of subjects with severe angina results in less pain and an improved ability to walk. The transplant subjects also experienced fewer deaths than those who didn't receive stem cells.

18 Nov 2009

Genzyme and Isis Pharmaceuticals announce phase 3 study data of mipomersen

Genzyme Corp. and Isis Pharmaceuticals Inc. announced that data from the phase 3 study of mipomersen in patients with homozygous familial hypercholesterolemia (hoFH) were presented today at the American Heart Association’s Scientific Sessions.

17 Nov 2009

Alkermes commences phase 2 study of ALKS 33 in patients with alcohol dependence

Alkermes, Inc. today announced the initiation of a phase 2 clinical study of ALKS 33, an investigational oral opioid modulator for the potential treatment of alcohol dependence and other central nervous system disorders. The study will assess the safety and efficacy of multiple doses of ALKS 33 in patients with alcohol dependence and is designed to further define the clinical profile of ALKS 33.

17 Nov 2009

Anacor Pharmaceuticals commences patient dosing in AN3365 Phase I clinical study

Anacor Pharmaceuticals today announced that it has dosed the first patient in a Phase I clinical study for AN3365, a novel boron-based, small-molecule drug candidate in development for the treatment of hospital infections caused by Gram-negative bacteria. The study will evaluate the safety, tolerability and pharmacokinetics of AN3365 in healthy volunteers.

17 Nov 2009

New, reversible antiplatelet drug not superior than irreversible one in patients undergoing PCI

A new, reversible antiplatelet drug did not demonstrate superiority over a current irreversible one in reducing the composite of death, heart attack or ischemia-related revascularization in the 48 hours after angioplasty, researchers reported in a late-breaking clinical trial presentation at the American Heart Association's Scientific Sessions 2009.

17 Nov 2009

BioSante Pharmaceuticals applauds Boehringer Ingelheim for developing a therapy to treat HSDD

BioSante Pharmaceuticals, Inc., a specialty pharmaceutical company developing products for female sexual health, including LibiGel® for the treatment of hypoactive sexual desire disorder (HSDD), applauds the efforts of Boehringer Ingelheim to develop a therapy to treat this unmet medical need.

17 Nov 2009

Antidepressant drug is effective in treating women with low libido

The drug flibanserin, which was originally created as an antidepressant, is effective in treating women with low libido, pooled results from three separate clinical trials have found.

17 Nov 2009

Mount Sinai School of Medicine to participate in Phase 2 clinical trial to test gene therapy treatment for Alzheimer's disease

17 Nov 2009

Results of Phase III clinical trials of flibanserin for treatment of HSDD in pre-menopausal women released

Data from pivotal Phase III clinical trials demonstrate that flibanserin 100mg increased the number of satisfying sexual events (SSE) and sexual desire (the co-primary endpoints) while decreasing the distress associated with Hypoactive Sexual Desire Disorder (HSDD).

16 Nov 2009

FDA approves Lysteda for treating menorrhagia

Xanodyne Pharmaceuticals, Inc., an integrated specialty pharmaceutical company with both development and commercial capabilities focused on women's healthcare and pain management, announced today that Lysteda(TM) (tranexamic acid) oral tablets has received U.S. Food and Drug Administration (FDA) approval for treatment of women suffering from cyclic heavy menstrual bleeding (HMB), also known as menorrhagia.

16 Nov 2009

Alkermes' phase 3 trial of naltrexone XR-NTX meets primary endpoint

Alkermes, Inc. today announced positive preliminary results from a phase 3 clinical trial of naltrexone for extended-release injectable suspension (XR-NTX) for the treatment of opioid dependence. The six-month phase 3 study met its primary efficacy endpoint and data showed that patients treated once-monthly with XR-NTX demonstrated statistically significant higher rates of clean (opioid-free) urine screens, compared to patients treated with placebo, as measured by the cumulative distribution of clean urine screens (p<0.0002).

16 Nov 2009

Placebo News and Research

Once-a-day dosing clinical study of udenafil for erectile dysfunction completed

Positive results from REVIVE, a phase 3 pivotal study of avanafil announced

Phase 2/3 study results of Genzyme's APB announced

Ambrisentan improves health and exercise capacity of PAH patients, find researchers

CRESTOR reduces major cardiovascular events in women by 46%

Study examines link between folic acid and cancer incidence

Sildenafil improves heart function in youngsters with single ventricle congenital heart disease

Phase 2 clinical trial to test gene therapy treatment for Alzheimer's disease

Phase III randomized clinical trial for Alpharadin to be commenced

Transplanting people's own stem cells into heart muscle lessens pain and improves ability to walk

Genzyme and Isis Pharmaceuticals announce phase 3 study data of mipomersen

Alkermes commences phase 2 study of ALKS 33 in patients with alcohol dependence

Anacor Pharmaceuticals commences patient dosing in AN3365 Phase I clinical study

New, reversible antiplatelet drug not superior than irreversible one in patients undergoing PCI

BioSante Pharmaceuticals applauds Boehringer Ingelheim for developing a therapy to treat HSDD

Antidepressant drug is effective in treating women with low libido

Mount Sinai School of Medicine to participate in Phase 2 clinical trial to test gene therapy treatment for Alzheimer's disease

Results of Phase III clinical trials of flibanserin for treatment of HSDD in pre-menopausal women released

FDA approves Lysteda for treating menorrhagia

Alkermes' phase 3 trial of naltrexone XR-NTX meets primary endpoint

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