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Positive data from Shire's Phase III trial of TKT-034 in Type 1 Gaucher disease patients who switched to VPRIV

Shire plc, the global specialty biopharmaceutical company, today presented positive data from a Phase III clinical trial (TKT-034) designed to evaluate the safety of switching to VPRIV (velaglucerase alfa for injection), from imiglucerase, as well as an interim analysis of safety data from an ongoing multicenter open-label treatment protocol (HGT-GCB-058) implemented to provide VPRIV to patients affected by the continuing shortage of imiglucerase.

26 Mar 2010

New topical drug may help treat diabetic eye disease

Early-stage human clinical trials showed that a new topical drug was safe and had biological effects in a type of diabetic eye disease, and may offer researchers a new approach to prevent and treat diabetic macular edema.

26 Mar 2010

Eli Lilly supports SNM's initiative to advance innovative therapies

SNM is pleased to announce that biopharmaceutical company, Eli Lilly and Company, has joined SNM's Clinical Trials Network-making it the third major company to formally support this initiative to facilitate the development of promising therapeutic medicines.

26 Mar 2010

Oramed Pharmaceuticals completes Phase 2b study of ORMD-0801 oral insulin capsule

Oramed Pharmaceuticals Inc. announced today the completion of its' pivotal Phase 2b clinical study of its oral insulin capsule, ORMD-0801. The Company expects to report results from this study within the coming weeks.

26 Mar 2010

SMA Foundation completes biomarker study for Spinal Muscular Atrophy

The Spinal Muscular Atrophy (SMA) Foundation, a nonprofit organization dedicated to accelerating the development of a treatment for SMA, is pleased to announce the completion of a pilot study to identify Biomarkers for Spinal Muscular Atrophy (BforSMA) and the discovery of over 400 candidate biomarkers.

26 Mar 2010

Interim results from ZALBIN Phase 2B trial in chronic hepatitis C patients announced

Human Genome Sciences, Inc. today announced interim results through Week 12 following the end of treatment in a Phase 2b clinical trial conducted by Novartis to evaluate the safety and efficacy of ZALBIN™ (albinterferon alfa-2b), an investigational agent, administered monthly in combination with ribavirin in 391 treatment-naive patients with genotypes 2 and 3 chronic hepatitis C virus. The primary efficacy endpoint is sustained virologic response (SVR) at Week 48 (24 weeks following the end of treatment).

26 Mar 2010

FDA approves Mirapex ER tablets for signs and symptoms of idiopathic PD

Boehringer Ingelheim Pharmaceuticals, Inc., today announced that the U.S. Food and Drug Administration has approved once-daily Mirapex ER® (pramipexole dihydrochloride) extended-release tablets for the signs and symptoms of idiopathic Parkinson's disease, which includes early and advanced PD. PD is the second most common chronic neurological disorder in older adults after Alzheimer's. Parkinson's disease has no cure.

26 Mar 2010

Positive results from Stage A pivotal study of 2009 A/H1N1 VLP pandemic influenza vaccine

Novavax, Inc. announced today positive results from the entire 1,000 subject Stage A of its two-stage pivotal study evaluating the safety and immunogenicity of Novavax's unadjuvanted 2009 A/H1N1 virus-like particle pandemic influenza vaccine.

26 Mar 2010

Hana Biosciences reports net loss of $5M for fourth quarter 2009

Hana Biosciences Inc., a biopharmaceutical company focused on strengthening the foundation of cancer care, today reported financial results for the fourth quarter and year ended December 31, 2009, and provided a corporate update.

26 Mar 2010

Aastrom Biosciences' RESTORE-CLI trial: Final patient treated

Aastrom Biosciences, Inc., a leading developer of autologous cellular therapies for the treatment of severe cardiovascular diseases, today reported that the final patient has been treated in the company's ongoing multi-center, randomized, double-blind, placebo-controlled U.S. Phase 2b clinical trial designated RESTORE-CLI. This patient received intramuscular injections of either Aastrom's tissue repair cells (TRCs) or electrolyte solution (placebo) for the treatment of critical limb ischemia (CLI), the end-stage of peripheral arterial disease.

26 Mar 2010

Arena Pharmaceuticals initiates patient screening for phase 1 clinical trial of APD916

Arena Pharmaceuticals, Inc. announced today the initiation of patient screening in a Phase 1 clinical trial of APD916, a novel oral drug candidate discovered by Arena that targets the histamine H3 receptor for the treatment of narcolepsy and cataplexy.

25 Mar 2010

Venn Life Sciences completes $3 mn funding, acquires Dutch CRO UpToYou

Venn Life Sciences has just completed a significant funding round of over $3 million, to enable it to further accelerate the growth of its business.

25 Mar 2010

Scott & White seeks breast cancer patients for Phase II clinical trial

Scott & White Healthcare researchers are studying an investigational agent that targets metastatic breast cancer to find if it can stop cancer cells from continuing to grow.

25 Mar 2010

UCSF Study: HIV prevention services in clinical settings reduces risk behaviors

UCSF researchers have shown that delivering HIV prevention services to people living with HIV in clinical settings can sharply reduce their sexual risk behaviors.

25 Mar 2010

New ultrasound device shows promising results for treating joint and muscle pain

It's lightweight, smaller than most iPods and can deliver low-intensity ultrasound therapy for up to 10 hours. It just might revolutionize pain relief - and save patients time.

25 Mar 2010

Isotechnika Pharma releases fourth quarter financial results; reviews operational and scientific highlights for 2009

Isotechnika Pharma Inc. has released its financial results for the fourth quarter and year ended December 31, 2009 and provided a review of the Company's operational and scientific highlights for 2009

25 Mar 2010

Clinic sites seek gay men to participate in HIV vaccine study

Clinic sites in 13 cities across the U.S. are looking for a total of 1,350 HIV-negative gay men to participate in the latest HIV vaccine study from the HIV Vaccine Trials Network (HVTN). And they're using social media to help reach these individuals where they are, which, these days, is increasingly online.

25 Mar 2010

MediciNova reports net loss of $5.9 million for 2009 fourth quarter

MediciNova, Inc., a biopharmaceutical company that is publicly traded on the Nasdaq Global Market and the Hercules Market of the Osaka Securities Exchange (Code Number: 4875), today announced financial results for the fourth quarter and full year ended December 31, 2009.

25 Mar 2010

Alzheimer's Foundation of America applauds dementia-related provisions in health reform law

The Alzheimer's Foundation of America (AFA) is extremely pleased that the historic health reform signed into law by President Obama late this morning, after passing the U.S. House of Representatives on Sunday and the U.S. Senate in December, includes a number of provisions that are especially significant for AFA's constituents—and bode well for improving quality of life for individuals with Alzheimer's disease and related dementias, and their family caregivers. In particular, we are grateful that the final action addresses many of the practical and financial needs faced daily by this population, speaks to preventative issues and bolsters training of dementia care professionals.

25 Mar 2010

Hepatic encephalopathy drug XIFAXAN 550 mg tablets receives FDA marketing approval

Salix Pharmaceuticals, Ltd. today announced the U.S. Food and Drug Administration has granted marketing approval for XIFAXAN 550 mg tablets for reduction in risk of overt hepatic encephalopathy recurrence in patients 18 years of age or older. HE is a serious disorder caused by chronic liver failure, resulting in cognitive, psychiatric and motor impairments. This approval was supported by findings from the largest randomized trial of maintenance therapy in HE conducted to date, which assessed the efficacy and safety of XIFAXAN 550 mg tablets and demonstrated a statistically significant and clinically meaningful reduction in the risk of overt HE recurrence.

25 Mar 2010

Clinical Trial News and Research

Positive data from Shire's Phase III trial of TKT-034 in Type 1 Gaucher disease patients who switched to VPRIV

New topical drug may help treat diabetic eye disease

Eli Lilly supports SNM's initiative to advance innovative therapies

Oramed Pharmaceuticals completes Phase 2b study of ORMD-0801 oral insulin capsule

SMA Foundation completes biomarker study for Spinal Muscular Atrophy

Interim results from ZALBIN Phase 2B trial in chronic hepatitis C patients announced

FDA approves Mirapex ER tablets for signs and symptoms of idiopathic PD

Positive results from Stage A pivotal study of 2009 A/H1N1 VLP pandemic influenza vaccine

Hana Biosciences reports net loss of $5M for fourth quarter 2009

Aastrom Biosciences' RESTORE-CLI trial: Final patient treated

Arena Pharmaceuticals initiates patient screening for phase 1 clinical trial of APD916

Venn Life Sciences completes $3 mn funding, acquires Dutch CRO UpToYou

Scott & White seeks breast cancer patients for Phase II clinical trial

UCSF Study: HIV prevention services in clinical settings reduces risk behaviors

New ultrasound device shows promising results for treating joint and muscle pain

Isotechnika Pharma releases fourth quarter financial results; reviews operational and scientific highlights for 2009

Clinic sites seek gay men to participate in HIV vaccine study

MediciNova reports net loss of $5.9 million for 2009 fourth quarter

Alzheimer's Foundation of America applauds dementia-related provisions in health reform law

Hepatic encephalopathy drug XIFAXAN 550 mg tablets receives FDA marketing approval

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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