Efficacy News and Research

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Erasmus Medical Center Professor to present LEADERS trial result at TCT symposium

Three-year data from the prospective, randomized LEADERS trial demonstrate the equivalence of a biolimus A9-eluting stent with a biodegradable polymer vs. a sirolimus-eluting stent with a durable polymer. The results will be presented at the 22nd annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium, sponsored by the Cardiovascular Research Foundation.

23 Sep 2010

NC State receives $1.8M defense grant to test molecule efficacy against antibiotic-resistant infections

A new $1.8 million grant from the Department of Defense will allow North Carolina State University researchers to work with the Walter Reed Institute of Research to further test the effectiveness of molecules that have shown great promise in combating antibiotic-resistant infections.

23 Sep 2010

Phase II study: Fostamatinib improves outcomes in RA patients

AstraZeneca's new oral syk inhibitor, fostamatinib (R788), recently in-licensed from Rigel Pharmaceuticals, Inc., significantly improved outcomes of patients with rheumatoid arthritis who responded inadequately to ongoing treatment with methotrexate, according to phase II study data published in The New England Journal of Medicine today.

23 Sep 2010

NCI selects Caliper's Quantum FX microCT system to study tumor models in lung cancer

Caliper Life Sciences, Inc., a leading provider of tools and services for drug discovery and life sciences research, today announced that the National Cancer Institute has purchased Caliper's Quantum FX, a stand-alone microCT system for pre-clinical imaging, to study spontaneous tumor models in lung cancer.

23 Sep 2010

Implantation of new bioprosthetic-tissue valve in patients with severe aortic stenosis saves lives

Implantation of a new bioprosthetic-tissue valve into the hearts of patients who have severe aortic stenosis and are too sick or too old for open-heart surgery has been found to both save lives and improve the quality of those lives, according to a new multicenter study, to be published online at 2 p.m. Pacific time today in the New England Journal of Medicine.

23 Sep 2010

FDA and EMA accept regulatory submissions of vandetanib for advanced medullary thyroid cancer

AstraZeneca today announced that the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have accepted regulatory submissions for review of the investigational drug vandetanib in the treatment of patients with advanced medullary thyroid cancer (MTC). The FDA also granted priority review status for the new drug application and set a Prescription Drug User Fee Act (PDUFA) action date of 7 January 2011.

23 Sep 2010

Covidien launches Puritan Bennett 560 ventilator in Europe

Covidien, a leading global healthcare products company and recognized innovator in mechanical ventilation and respiratory care devices, today announced that the Puritan Bennett™ 560 ventilator is now available in Europe. The Puritan Bennett 560 ventilator is compact and portable, weighing just 4.5 kg. This lightweight device provides mobile respiratory support, enabling ventilated adult and pediatric patients to pursue regular activities with peace of mind.

23 Sep 2010

CSI to present CALCIUM 360° Study results at TCT symposium

Cardiovascular Systems, Inc., announced today that its CALCIUM 360° Study, the first-of-its kind prospective, randomized feasibility study, demonstrated the safety and effectiveness of plaque modification with the Diamondback 360 PAD System versus the standard of care treatment (balloon angioplasty) in below-the-knee arteries.

23 Sep 2010

Biogen Idec concurs with FDA on safety monitoring for Gilenya through REMS

Biogen Idec is committed to improving the lives of people with multiple sclerosis (MS), and no company is doing more for these patients. There has been a desire within the MS community for an oral treatment for a long time, and the approval of Gilenya has made this a reality.

23 Sep 2010

DSMB authorizes Oxygen Biotherapeutics' next cohort of Oxycyte emulsion study in severe non-penetrating TBI

Oxygen Biotherapeutics, Inc. reported today that the Data Safety Monitoring Board overseeing the company's ongoing Phase II-b trial has, based on the results of the first cohort of patients, authorized the company to move forward with the next cohort of the study. This trial is a randomized, single-dose, placebo-controlled, double-blind, dose-escalation study to evaluate the safety and tolerability of our Oxycyte® emulsion in patients with severe non-penetrating traumatic brain injury.

23 Sep 2010

Metabolon publishes biomarker validation study results for periodontal diseases

Metabolon, Inc., leaders in global metabolomics, biomarker discovery and biochemical analysis, announces the publication of "Assessment of Dentifrice on Periodontal Disease Biomarkers in Gingival Crevicular Fluid", in the Journal of Periodontology.

23 Sep 2010

TAXUS Element Stent has comparable levels of TLR and late loss in diabetic and non-diabetic patients

Boston Scientific Corporation today announced results from an analysis of 1,166 patients from its PERSEUS clinical program comparing the performance of the TAXUS® Element™ Paclitaxel-Eluting Coronary Stent System in diabetic versus non-diabetic patients. Results demonstrated that despite the known increased risk of restenosis for diabetics versus non-diabetics in patients undergoing coronary revascularization, the TAXUS Element Stent had comparable levels of target lesion revascularization (TLR) and late loss in both diabetic and non-diabetic patients.

23 Sep 2010

U.S. joins whistleblower suit against Pfizer for drug marketing

The Wall Street Journal: "The Justice Department is trying to take the lead in a lawsuit accusing Pfizer Inc.'s Wyeth unit of improperly promoting an organ-transplant drug for unauthorized uses and paying illegal kickbacks to doctors. The lawsuit was filed by two former Wyeth sales representatives who were responsible for promoting Rapamune, an immunosuppressant used to prevent the body's rejection of transplanted kidneys.

23 Sep 2010

Weight-based taribavirin reduces anemia, increases sustained virologic response

Researchers at Cedars-Sinai Medical Center and 50 other centers found that weight-based dosing of taribavirin reduces rates of anemia while increasing sustained virologic response (SVR) in patients with chronic hepatitis C (HCV). Full details of this study are available in the October issue of Hepatology, a journal published by Wiley-Blackwell on behalf of the American Association for the Study of Liver Diseases (AASLD).

23 Sep 2010

Boston announces TAXUS ATLAS clinical trial data for complex lesions

Boston Scientific Corporation today announced comprehensive data from the TAXUS ATLAS clinical program, a series of global, prospective, single-arm trials evaluating the TAXUS Liberte Paclitaxel-Eluting Stent System in a variety of lesions and patient groups.

23 Sep 2010

Abbott's Humira gains first-line biologic use for psoriasis treatment: Report

Decision Resources, one of the world's leading research and advisory firms for pharmaceutical and healthcare issues, finds that while Amgen/Stiefel/Pfizer's Enbrel is the most popular biologic across all lines of therapy for psoriasis treatment in newly diagnosed patients, Abbott's Humira is gaining increasing use as a first-line biologic at Enbrel's expense.

23 Sep 2010

Santaris Pharma paves way to conduct clinical trial of miravirsen in patients with HVC

Santaris Pharma A/S, a clinical-stage biopharmaceutical company focused on the discovery and development of RNA-targeted therapies, today announced that it has advanced miravirsen (SPC3649), the first microRNA-targeted drug to enter clinical trials, into Phase 2 studies to assess the safety and tolerability of the drug in treatment-naive patients infected with the Hepatitis C virus.

22 Sep 2010

AMS reports 12-month study results of Elevate Apical and Posterior Prolapse Repair System

American Medical Systems, a leading provider of world-class devices and therapies for both male and female pelvic health, today announced the results of a 12-month single-arm, prospective multi-center study of the Elevate® Apical and Posterior Prolapse Repair System. The pelvic organ prolapse quantification exam (POP-Q), used to quantify, describe, and stage pelvic support, was implemented in the study and concluded efficacy rates of Stage 1 or less to be 89.2% for Apical and 91.7% for Posterior.

22 Sep 2010

Results of custirsen Phase 2 trial for advanced prostate cancer published in Journal of Clinical Oncology

OncoGenex Pharmaceuticals, Inc. announced today publication of results from a randomized Phase 2 trial in the Journal of Clinical Oncology. The trial results showed a survival benefit with the investigational agent OGX-011/TV1011 (custirsen) in patients with advanced prostate cancer. The median overall survival for patients who were treated with custirsen plus first-line docetaxel/prednisone was 23.8 months compared to 16.9 months for patients treated with docetaxel/prednisone alone.

22 Sep 2010

Phase I/II DIGNITY trial abstract of ThermoDox accepted for poster session at 2010 Breast Cancer Symposium

Celsion Corporation announced today that an abstract on its Phase I/II DIGNITY trial of ThermoDox in Recurrent Chest Wall Breast Cancer has been accepted for a poster session at the 2010 Breast Cancer Symposium. The abstract will provide updated clinical results, as well as the rationale and design of the DIGNITY study, which is evaluating ThermoDox in combination with microwave hyperthermia in women with RCW Breast Cancer.

22 Sep 2010

Efficacy News and Research

Erasmus Medical Center Professor to present LEADERS trial result at TCT symposium

NC State receives $1.8M defense grant to test molecule efficacy against antibiotic-resistant infections

Phase II study: Fostamatinib improves outcomes in RA patients

NCI selects Caliper's Quantum FX microCT system to study tumor models in lung cancer

Implantation of new bioprosthetic-tissue valve in patients with severe aortic stenosis saves lives

FDA and EMA accept regulatory submissions of vandetanib for advanced medullary thyroid cancer

Covidien launches Puritan Bennett 560 ventilator in Europe

CSI to present CALCIUM 360° Study results at TCT symposium

Biogen Idec concurs with FDA on safety monitoring for Gilenya through REMS

DSMB authorizes Oxygen Biotherapeutics' next cohort of Oxycyte emulsion study in severe non-penetrating TBI

Metabolon publishes biomarker validation study results for periodontal diseases

TAXUS Element Stent has comparable levels of TLR and late loss in diabetic and non-diabetic patients

U.S. joins whistleblower suit against Pfizer for drug marketing

Weight-based taribavirin reduces anemia, increases sustained virologic response

Boston announces TAXUS ATLAS clinical trial data for complex lesions

Abbott's Humira gains first-line biologic use for psoriasis treatment: Report

Santaris Pharma paves way to conduct clinical trial of miravirsen in patients with HVC

AMS reports 12-month study results of Elevate Apical and Posterior Prolapse Repair System

Results of custirsen Phase 2 trial for advanced prostate cancer published in Journal of Clinical Oncology

Phase I/II DIGNITY trial abstract of ThermoDox accepted for poster session at 2010 Breast Cancer Symposium

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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