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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

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.

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

Aradigm commences patient dosage in Phase 2 trial of novel inhaled ciprofloxacin formulation

Aradigm Corporation today announced that the first patient was dosed in a 6-month, multicenter, international Phase 2 clinical trial of a novel version of inhaled ciprofloxacin (ARD-3150) in 40 adult patients with non-cystic fibrosis bronchiectasis.

16 Nov 2009

FDA issues a Complete Response Letter for Human Genome Sciences' raxibacumab BLA

Human Genome Sciences, Inc. today announced that it has received a Complete Response Letter from the U.S. Food and Drug Administration (FDA) relating to the Company’s Biologics License Application (BLA) requesting the approval of raxibacumab for use in the treatment of inhalational anthrax. The FDA issues Complete Response Letters to request additional information needed to complete the review of a BLA.

16 Nov 2009

Genta announces Phase 3 trial results of Genasense

Genta Incorporated today announced preliminary results from AGENDA, the Company’s Phase 3 trial of Genasense® (oblimersen sodium) Injection in patients with advanced melanoma. AGENDA is a randomized, double-blind, placebo-controlled trial of dacarbazine (DTIC) administered with or without Genasense® in patients who have not previously received chemotherapy.

16 Nov 2009

Protox Therapeutics announces financial results for the third quarter ended September 30, 2009

Protox Therapeutics Inc. (TSX: PRX), a leader in the development of receptor targeted fusion proteins, today announced financial results for the third quarter, ended September 30, 2009.

16 Nov 2009

SANUWAVE Health reports financial results for the three months ended September 30, 2009

SANUWAVE Health, Inc.,, an emerging medical technology company focused on the development and commercialization of non-invasive, biological response activating devices in the regenerative medicine area, reports its achievements and financial results for the three and nine months ended September 30, 2009.

16 Nov 2009

Findings from post hoc analysis examining emotional lability from Phase 3 study data with Vyvanse announced

Shire plc (LSE: SHP, NASDAQ: SHPGY), the global specialty biopharmaceutical company, announced findings from a post hoc analysis examining emotional lability from Phase 3 study data with Vyvanse-. In this study, Vyvanse demonstrated significant improvement in Attention-Deficit/Hyperactivity Disorder (ADHD) symptoms as measured by the ADHD Rating Scale IV (ADHD-RS IV) and Connors' Parent Rating Scale-Revised Short (CPRS-RS) in children with ADHD aged 6 to 12 years.

16 Nov 2009

New reversible blood thinner for angioplasty patients not superior over placebo

A new reversible blood thinner for angioplasty patients wasn't superior over placebo for its primary combined endpoint of heart attack, all-cause mortality and need for revascularization, but it reduced mortality and in-stent blood clots, researchers reported in a late-breaking clinical trial presentation at the American Heart Association's Scientific Sessions 2009.

16 Nov 2009

Ore Pharmaceutical Holdings reports financial results and provides operational updates for third quarter 2009

Ore Pharmaceutical Holdings Inc. today reported financial results and provided an operational update for the third quarter ended September 30, 2009.

13 Nov 2009

Placebo News and Research

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

Aradigm commences patient dosage in Phase 2 trial of novel inhaled ciprofloxacin formulation

FDA issues a Complete Response Letter for Human Genome Sciences' raxibacumab BLA

Genta announces Phase 3 trial results of Genasense

Protox Therapeutics announces financial results for the third quarter ended September 30, 2009

SANUWAVE Health reports financial results for the three months ended September 30, 2009

Findings from post hoc analysis examining emotional lability from Phase 3 study data with Vyvanse announced

New reversible blood thinner for angioplasty patients not superior over placebo

Ore Pharmaceutical Holdings reports financial results and provides operational updates for third quarter 2009

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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