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FDA grants orphan drug designation for Aradigm's ciprofloxacin to manage bronchiectasis

Aradigm Corporation today announced it has received orphan drug designation from the U.S. Food and Drug Administration (FDA) for ciprofloxacin for inhalation for the management of bronchiectasis (BE).

6 Jun 2011

GTx to initiate two Ostarine Phase III trial for treatment of muscle wasting in patients with NSCLC

Following the conclusion of a series of meetings with the United States Food and Drug Administration (FDA), GTx, Inc. announced today the clinical trial design for the two Phase III Ostarine registration studies for the prevention and treatment of muscle wasting in patients with non-small cell lung cancer (NSCLC).

6 Jun 2011

United Therapeutics completes oral treprostinil Phase 3 trial on pulmonary arterial hypertension

United Therapeutics Corporation announced today the completion of its FREEDOM-M Phase 3 trial of treprostinil diethanolamine, an investigational sustained release oral formulation of treprostinil, a stable synthetic form of prostacyclin, in patients with pulmonary arterial hypertension (PAH).

6 Jun 2011

Estrogen therapy improves low bone density in teenage girls with anorexia nervosa

Estrogen therapy improves low bone density due to anorexia nervosa in teenage girls with the disease when given as a patch or as a low oral dose that is physiological.

6 Jun 2011

NCIC CTG's exemestane clinical trial data on breast cancer presented at ASCO 2011

A large international Canadian-led clinical trial investigating a new way to prevent breast cancer in women at increased risk of developing the disease has found that the drug exemestane reduces this risk by 65 per cent compared with placebo.

6 Jun 2011

FDA accepts Sunovion ciclesonide HFA nasal aerosol NDA for review

Sunovion Pharmaceuticals Inc. today announced that the New Drug Application (NDA) submitted for ciclesonide nasal aerosol in a hydrofluoroalkane (HFA) formulation has been accepted by the U.S. Food and Drug Administration.

6 Jun 2011

Celgene announces results of REVLIMID, docetaxel/prednisone phase II combination study on mCRPC

Celgene International Sàrl today announced results from a phase II investigator initiated study of REVLIMID (lenalidomide) in combination with Avastin (bevacizumab), docetaxel and prednisone in patients with metastatic castration-resistant prostate cancer were presented at the 2011 American Society of Clinical Oncology Annual Meeting in Chicago, Ill.

6 Jun 2011

Genentech's Avastin, chemotherapy Phase III combination study data on ovarian cancer presented at ASCO

Genentech, a member of the Roche Group, today announced results from OCEANS, a Phase III study evaluating Avastin (bevacizumab) in combination with chemotherapy followed by the continued use of Avastin alone in women with previously treated (recurrent) platinum-sensitive ovarian cancer.

6 Jun 2011

Bayer's radium-223 chloride Phase III trial in CRPC, bone metastases meet primary endpoint

Bayer HealthCare Pharmaceuticals Inc. today announced that the Phase III ALSYMPCA trial evaluating Bayer's investigational compound, radium-223 chloride, which is exclusively licensed from Algeta ASA, in patients with castration-resistant prostate cancer (CRPC) and bone metastases met its primary endpoint by significantly improving overall survival.

6 Jun 2011

Topiramate drug can help people lose weight

The drug topiramate can help people lose weight as long as they can tolerate the side effects, according to authors of a new study that reviewed the medical literature. Brazilian researchers will present the results Saturday at The Endocrine Society's 93rd Annual Meeting in Boston.

6 Jun 2011

Incyte's ruxolitinib Phase III trial data on myelofibrosis presented at ASCO 2011

Incyte Corporation announced today results from the global, pivotal Phase III clinical program of ruxolitinib in patients with myelofibrosis (MF) at the 2011 American Society of Clinical Oncology (ASCO) Annual Meeting.

6 Jun 2011

Women with breast cancer do not benefit from flaxseed

Flaxseed provides no benefit in easing hot flashes among breast cancer patients and postmenopausal women, according to a Mayo Clinic and North Central Cancer Treatment Group study.

6 Jun 2011

Bristol-Myers Squibb's second YERVOY Phase 3 trial on metastatic melanoma meets primary endpoint

Bristol-Myers Squibb Company today announced results from a second Phase 3 randomized, double blind study demonstrating that YERVOY (ipilimumab) prolonged the lives of patients with metastatic melanoma.

6 Jun 2011

Exemestane reduces risk of breast cancer in high-risk, postmenopausal women

Today's major announcement at the American Society of Clinical Oncology annual meeting that the drug exemestane significantly reduces the risk of breast cancer in high-risk, postmenopausal women is the result of an international, randomized double-blind phase III clinical trial in which University at Buffalo researchers and hundreds of Western New York women played a critical role.

6 Jun 2011

New skin cancer drug brings hope

A new drug for the dreaded cancer melanoma is in the horizon. It is called Vemurafenib. This is a class of drug that cancer researchers are applauding today at the American Society of Clinical Oncology's annual meeting in Chicago.

5 Jun 2011

Sanofi's semuloparin Phase III study data against venous thromboembolism presented at ASCO 2011

Sanofi US announced today results of the pivotal SAVE-ONCO study which demonstrated that, in cancer patients initiating a chemotherapy regimen, investigational semuloparin significantly reduced the risk of the composite of symptomatic-deep vein thromboembolism (DVT), non-fatal pulmonary embolism (PE) or venous thromboembolism (VTE)-related death by 64%, meeting the study primary endpoint.

4 Jun 2011

Impax announces results of IPX066 ADVANCE-PD and APEX-PD Phase III study against Parkinson's

Impax Pharmaceuticals, the branded products division of Impax Laboratories, Inc., today announced that IPX066 ADVANCE-PD and APEX-PD Phase III clinical study data will be presented in Poster Sessions at the 15th International Congress of Parkinson's Disease and Movement Disorders Conference in Toronto, Canada, held from June 5 to June 9.

4 Jun 2011

Bionovo's Menerba Phase 2 trial data to be presented at Annual World Congress on Menopause

Bionovo, Inc., a pharmaceutical company focused on the discovery and development of safe and effective treatments for women's health and cancer, today announced it will be presenting data from the Phase 2 clinical trial of their lead drug candidate for postmenopausal symptoms, Menerba, to the international community at the 13th Annual World Congress on Menopause in Rome, Italy on June 11, 2011.

4 Jun 2011

Orexigen meets FDA to gain clarity on approval for Contrave NDA to treat obesity

Orexigen Therapeutics, Inc. announced today that it recently met with the Food and Drug Administration (FDA) regarding the New Drug Application for Contrave (naltrexone HCl/bupropion HCl) extended-release tablets for the treatment of obesity, including weight loss and maintenance of weight loss.

3 Jun 2011

Study to determine how vitamin D affects cardiac structure, functions in blacks with hypertension

A Wayne State University School of Medicine physician researcher has received a $1.9 million National Institutes of Health grant to study the role of vitamin D in halting and reducing subclinical cardiac damage in African-Americans suffering from high blood pressure.

3 Jun 2011

Placebo News and Research

FDA grants orphan drug designation for Aradigm's ciprofloxacin to manage bronchiectasis

GTx to initiate two Ostarine Phase III trial for treatment of muscle wasting in patients with NSCLC

United Therapeutics completes oral treprostinil Phase 3 trial on pulmonary arterial hypertension

Estrogen therapy improves low bone density in teenage girls with anorexia nervosa

NCIC CTG's exemestane clinical trial data on breast cancer presented at ASCO 2011

FDA accepts Sunovion ciclesonide HFA nasal aerosol NDA for review

Celgene announces results of REVLIMID, docetaxel/prednisone phase II combination study on mCRPC

Genentech's Avastin, chemotherapy Phase III combination study data on ovarian cancer presented at ASCO

Bayer's radium-223 chloride Phase III trial in CRPC, bone metastases meet primary endpoint

Topiramate drug can help people lose weight

Incyte's ruxolitinib Phase III trial data on myelofibrosis presented at ASCO 2011

Women with breast cancer do not benefit from flaxseed

Bristol-Myers Squibb's second YERVOY Phase 3 trial on metastatic melanoma meets primary endpoint

Exemestane reduces risk of breast cancer in high-risk, postmenopausal women

New skin cancer drug brings hope

Sanofi's semuloparin Phase III study data against venous thromboembolism presented at ASCO 2011

Impax announces results of IPX066 ADVANCE-PD and APEX-PD Phase III study against Parkinson's

Bionovo's Menerba Phase 2 trial data to be presented at Annual World Congress on Menopause

Orexigen meets FDA to gain clarity on approval for Contrave NDA to treat obesity

Study to determine how vitamin D affects cardiac structure, functions in blacks with hypertension

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How Omics Technologies Are Transforming Biological Research and Drug Discovery

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