Efficacy News and Research

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Avid, Cardinal Health partner to detect Alzheimer's disease in living patients

Currently, Alzheimer's disease cannot be definitively diagnosed until after death, when a brain autopsy is performed on a patient and evidence of beta-amyloid plaque deposits in the brain – which are a characteristic pathology of the disease – can be found. Accurate diagnosis during life can be challenging, particularly in the early stages of Alzheimer's, when symptoms are mild and non-definitive. However, Avid Radiopharmaceuticals, Inc. and Cardinal Health are working together to change that.

26 Mar 2010

FDA Advisory Committee to review VIVUS' NDA for Qnexa

VIVUS, Inc. today announced that the Endocrinologic and Metabolic Drugs Advisory Committee of the U.S. Food and Drug Administration is tentatively scheduled to review the Company's New Drug Application for Qnexa® for the treatment of obesity on July 15, 2010.

26 Mar 2010

Bevacizumab/paclitaxel/carboplatin regimen attains gold-standard status for treatment of non-small-cell lung cancer

Decision Resources, one of the world's leading research and advisory firms for pharmaceutical and healthcare issues, finds that the bevacizumab (Genentech/Roche/Chugai's Avastin)/paclitaxel (Bristol-Myers Squibb's Taxol, generics)/carboplatin (Bristol-Myers Squibb's Paraplatin, generics) regimen will remain Decision Resources' proprietary clinical gold standard for the treatment of advanced non-small-cell lung cancer through 2018.

26 Mar 2010

RXi Pharmaceuticals to present advances in RNAi therapeutics at 3rd International Scar Club Meeting

RXi Pharmaceuticals Corporation, a biopharmaceutical company pursuing the development and commercialization of proprietary therapeutics based on RNA interference (RNAi), announced that Pamela Pavco, Ph.D., Vice President of Pharmaceutical Development, will be presenting at the 3rd International Scar Club Meeting in Montpellier, France on March 26, 2010.

26 Mar 2010

MGH to create registry of patients who had OCT of coronary arteries

Massachusetts General Hospital, together with a coalition of 20 international sites in five countries, will create the world's largest registry of patients who have had optical coherence tomography of the coronary arteries.

26 Mar 2010

New diagnostic test for early detection of Alzheimer's disease

A new test developed by Japanese scientists may revolutionize how and when physicians diagnose Alzheimer's disease.

26 Mar 2010

NellOne's lead candidate for skeletal muscle wound healing and myocardial infarction demonstrates potential efficacy

Two key, independent proof-of-concept studies conducted for NellOne Therapeutics, Inc. demonstrate the potential efficacy of the company’s lead therapeutic candidate for both skeletal muscle wound healing and myocardial infarction.

26 Mar 2010

Changing drug therapy can help breast cancer patients get full benefit of tamoxifen treatment

Recently published research has shown that some breast cancer patients taking tamoxifen may not be getting the full benefit of their treatment because they have also been taking selective serotonin reuptake inhibitors, prescribed drugs that inhibit the effect of an important enzyme.

26 Mar 2010

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

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

Santarus enrolls 510 patients in Phase III clinical program for budesonide MMX

Santarus, Inc., a specialty biopharmaceutical company, today announced the completion of enrollment of 510 patients in a U.S. Phase III clinical study to evaluate budesonide MMX® administered over eight weeks for the induction of remission of mild or moderate active ulcerative colitis. This is the second Phase III clinical study being conducted in collaboration with Cosmo Technologies Ltd., a subsidiary of Cosmo Pharmaceuticals SpA, as part of the budesonide MMX Phase III clinical program for U.S. registration.

26 Mar 2010

Standard HCV therapy less effective in urban minority patients: Study

A recent study confirms that the standard hepatitis C therapy, pegylated interferon and ribavirin, is significantly less effective in urban minority patients treated in an ordinary clinical practice setting compared with results produced during clinical trials.

26 Mar 2010

Independent DMC recommends continuance of enrollment in Eisai's Phase III ACCESS trial

Eisai Inc. announced today that the Phase III ACCESS (A Controlled Comparison of Eritoran and Placebo in Patients with Severe Sepsis) trial of the investigational compound eritoran (E5564) will continue enrolling to the preset goal of 2,000 patients. As part of a planned interim analysis, an independent Data Monitoring Committee (DMC) has evaluated efficacy and safety data on the first 1,500 subjects to complete the 28-day follow-up in the Phase III ACCESS trial.

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

Hepatitis C treatment less effective in urban minority patients

A recent study confirms that the standard hepatitis C (HCV) therapy, pegylated interferon and ribavirin, is significantly less effective in urban minority patients treated in an ordinary clinical practice setting compared with results produced during clinical trials. Results of this study appear in the April issue of Hepatology, a journal published by Wiley-Blackwell on behalf of the American Association for the Study of Liver Diseases.

25 Mar 2010

Techulon, UC sign worldwide exclusive license agreements to market Glycofect-Transfection Reagent

Techulon Inc., a life sciences company, has signed worldwide exclusive license agreements with the University of Cincinnati to manufacture and sell novel transfection reagents used for research and therapeutic delivery of nucleic acids.

25 Mar 2010

BeaconEquity.com announces investment report on AEterna Zentaris

BeaconEquity.com announces an investment report featuring AEterna Zentaris Inc. (Nasdaq:AEZS). The report includes financial, comparative and investment analyses, and pertinent industry information you need to know to make an educated investment decision.

25 Mar 2010

Efficacy News and Research

Avid, Cardinal Health partner to detect Alzheimer's disease in living patients

FDA Advisory Committee to review VIVUS' NDA for Qnexa

Bevacizumab/paclitaxel/carboplatin regimen attains gold-standard status for treatment of non-small-cell lung cancer

RXi Pharmaceuticals to present advances in RNAi therapeutics at 3rd International Scar Club Meeting

MGH to create registry of patients who had OCT of coronary arteries

New diagnostic test for early detection of Alzheimer's disease

NellOne's lead candidate for skeletal muscle wound healing and myocardial infarction demonstrates potential efficacy

Changing drug therapy can help breast cancer patients get full benefit of tamoxifen treatment

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

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

Santarus enrolls 510 patients in Phase III clinical program for budesonide MMX

Standard HCV therapy less effective in urban minority patients: Study

Independent DMC recommends continuance of enrollment in Eisai's Phase III ACCESS trial

Aastrom Biosciences' RESTORE-CLI trial: Final patient treated

Hepatitis C treatment less effective in urban minority patients

Techulon, UC sign worldwide exclusive license agreements to market Glycofect-Transfection Reagent

BeaconEquity.com announces investment report on AEterna Zentaris

Bringing real-time analytics to downstream bioprocess monitoring

Designing fluidic architecture for scalable diagnostic platforms

Evaluating new approaches for rare disease genomics

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