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New clinical data for CoreValve transcatheter aortic valve replacement system presented at EuroPCR

New clinical data presented today at EuroPCR demonstrate positive long-term performance and durability for the CoreValve transcatheter aortic valve replacement system from Medtronic, Inc. Two-year results from the pivotal 18-French CoreValve multicenter prospective study provide important additional evidence supporting wider use of the world's market-leading transcatheter aortic valve.

26 May 2010

Medtronic’s Resolute zotarolimus-eluting stent as effective as Xience V everolimus-eluting stent: Study

The highly anticipated first results of the RESOLUTE All Comers study were presented today during the late-breaking clinical trial session of the 2010 EuroPCR meeting. In this novel 2,292-patient randomized trial, the Resolute zotarolimus-eluting stent from Medtronic, Inc. was found to be as safe and effective as the Xience® V everolimus-eluting stent from Abbott Laboratories.

26 May 2010

6-month results of NovoStent's SAMBA trial for atherosclerotic disease in SFA and popliteal arteries

NovoStent Corporation, a privately held medical device company, today announced the 6-month follow-up results of the company's European clinical trial evaluating the use of its SAMBA Stent and Delivery System in the treatment of superficial femoral and popliteal artery disease. The SAMBA Stent was designed to treat the highly varied presentation of atherosclerotic disease in the superficial femoral (SFA) and popliteal arteries by providing a unique combination of increased vessel coverage, strength and flexibility.

26 May 2010

Boston Scientific initiates study to compare PROMUS Element Stent to XIENCE PRIME Stent System

Boston Scientific Corporation today announced the initiation of the PLATINUM PLUS clinical trial, an investigator-sponsored research (ISR) study designed to compare the performance of the PROMUS® Element™ Everolimus-Eluting Coronary Stent System to the XIENCE PRIME™ Everolimus-Eluting Coronary Stent System.

26 May 2010

Positive results reported from Phase IIa clinical trial of intranasal oxytocin for CDH

Trigemina, Inc., a Mountain View based privately-held biopharmaceutical company, reports positive results from a time-based interim analysis of its Phase IIa clinical trial in Chronic Daily Headache. The trial is a collaborative effort between Trigemina and Dr. Egilius Spierings of MedVadis Research Corporation located outside of Boston. The study compares intranasal oxytocin with placebo in patients suffering from CDH.

26 May 2010

NEVO Sirolimus-eluting Coronary Stent demonstrates safety and efficacy outcomes at 12 months

At 12 months the NEVO™ Sirolimus-eluting Coronary Stent has continued to demonstrate excellent safety and efficacy outcomes compared to Taxus® Liberte® according to new data presented today from the NEVO™ RES-I clinical trial. These results were presented as a late breaking trial at EuroPCR, the leading medical conference in Europe for physicians specializing in interventional cardiovascular medicine.

26 May 2010

HDL cholesterol can transform from good to bad actor in heart-disease process

We've all heard about the importance of raising HDL, or the so-called "good" cholesterol, and lowering LDL, or "bad" cholesterol, to improve heart health. While we've come to assume HDL cholesterol is an inherently good thing, a new study shows that for a certain group of patients, this is not always the case. The study is the first to find that a high level of the supposedly good cholesterol places a subgroup of patients at high risk for recurrent coronary events, such as chest pain, heart attack, and death.

26 May 2010

Osteopathic manipulative medicine reduces length of hospital stays for pneumonia patients: Research

Older patients battling pneumonia spent less time in the hospital when treated using osteopathic manipulative medicine - a drug-free form of hands-on medical care focusing on increasing muscle motion - in addition to conventional care, recently published research shows.

26 May 2010

GTx reports top line results from toremifene Phase III clinical trial for prostate cancer

GTx, Inc. today announced top line results of the Phase III clinical trial evaluating toremifene 20 mg, a selective estrogen receptor modulator, for the prevention of prostate cancer in men with high grade prostatic intraepithelial neoplasia, or PIN, a premalignant lesion of the prostate.

26 May 2010

Rockwell Medical's SFP Phase IIb data accepted for presentation at XLVII ERA-EDTA Congress

Rockwell Medical, a fully-integrated biopharmaceutical company offering innovative products and services targeting end-stage renal disease (ESRD), chronic kidney disease (CKD), and iron deficiency anemia, announced today that Phase IIb data for its lead drug candidate Soluble Ferric Pyrophosphate (SFP) have been accepted for presentation at the XLVII European Renal Association - European Dialysis and Transplant Association (ERA-EDTA) Congress, organized in collaboration with the Deutsche Gesellschaft fur Nephrologie (DGfN) in Munich, Germany, June 25-28, 2010.

25 May 2010

FDA grants priority review for Alkermes' VIVITROL sNDA for opioid dependence

Alkermes, Inc. today announced that the supplemental New Drug Application (sNDA) for VIVITROL® (naltrexone for extended-release injectable suspension) for opioid dependence has been designated a priority review by the U.S. Food and Drug Administration (FDA).

25 May 2010

DAPT Study expands into seven countries in the EU: HCRI

The Harvard Clinical Research Institute announced today that the DAPT Study has expanded into seven countries in the European Union. John Irving, MBChB, MRCP, M.D., consultant cardiologist at Ninewells Hospital in Dundee, United Kingdom, was the first European investigator to enroll patients into the study.

25 May 2010

Preclinical results of AMEP for metastatic melanoma presented at ASGCT Annual Meeting

BioAlliance Pharma SA, a company dedicated to the treatment and supportive care of cancer and AIDS patients, has presented efficacy, safety and biodistribution results on its new biotherapy AMEP™ for advanced and metastatic melanoma at the 13th Annual Meeting of the American Society of Gene and Cell Therapy in Washington, DC (May 17 - 22, 2010).

25 May 2010

Neuralstem updates progress of ongoing Phase I human clinical trial for ALS

Neuralstem, Inc. updated the progress of its ongoing Phase I human clinical trial to treat ALS (Amyotrophic Lateral Sclerosis, or Lou Gehrig's disease) at Emory University in Atlanta, Georgia. The company announced that, after reviewing the safety data from the first cohort of three patients, the Safety Monitoring Board has approved moving to the next cohort and transplantation of the fourth patient.

25 May 2010

Positive results from Phase 2 clinical trial for STA-9090 in Stage IIIB and Stage IV patients with NSCLC

Synta Pharmaceuticals Corp. today announced that clinical activity seen in the first stage of its trial for STA-9090 in Stage IIIB and Stage IV patients with non-small cell lung cancer, support advancing to the second stage of the trial. This result was achieved in the first pre-defined patient cohort to complete enrollment.

25 May 2010

Media outlets highlight studies presented at International Microbicides Conference

A study in Africa, presented Sunday at the International Microbicides Conference (M2010) in Pittsburgh, has shown that a man's risk of HIV infection doubles if his HIV-positive partner is pregnant, according to HealthDay News/U.S. News & World Report.

25 May 2010

Enrollment in phase II clinical trial of brentuximab vedotin for ALCL completed

Seattle Genetics, Inc. and Millennium: The Takeda Oncology Company, a wholly owned subsidiary of Takeda Pharmaceutical Company Limited, today announced that they have completed enrollment of a phase II clinical trial of brentuximab vedotin (SGN-35) for relapsed or refractory systemic anaplastic large cell lymphoma.

24 May 2010

Ortho-McNeil Pharmaceutical pleads guilty for promoting epilepsy drug Topamax for psychiatric use

Ortho-McNeil Pharmaceutical LLC, a subsidiary of Johnson & Johnson, pled guilty today in U.S. District Court in Boston to one count of misdemeanor violation of the Food, Drug & Cosmetic Act for illegally promoting its epilepsy drug Topamax for uses that were not approved by the FDA. The company was also sentenced at today's hearing.

24 May 2010

Phase 1 clinical trial of OXY111A initiated

NormOxys Inc., a biotechnology company developing a novel class of small molecule drugs which enhance the body's ability to deliver oxygen to diseased tissues, today announced that it has initiated a Phase 1 clinical trial of OXY111A, a novel allosteric modulator of affinity of oxygen to hemoglobin. NormOxys plans to initially develop this compound as a treatment for chronic heart failure and cancer indications.

24 May 2010

Volcano to highlight extensive pipeline of imaging and therapy products at EuroPCR 2010

Volcano Corporation announced today the company's plans to highlight its new product launches, presence in live cases, and participation in late breaking trials during EuroPCR from May 25 – 28 in Paris.

24 May 2010

Clinical Trial News and Research

New clinical data for CoreValve transcatheter aortic valve replacement system presented at EuroPCR

Medtronic’s Resolute zotarolimus-eluting stent as effective as Xience V everolimus-eluting stent: Study

6-month results of NovoStent's SAMBA trial for atherosclerotic disease in SFA and popliteal arteries

Boston Scientific initiates study to compare PROMUS Element Stent to XIENCE PRIME Stent System

Positive results reported from Phase IIa clinical trial of intranasal oxytocin for CDH

NEVO Sirolimus-eluting Coronary Stent demonstrates safety and efficacy outcomes at 12 months

HDL cholesterol can transform from good to bad actor in heart-disease process

Osteopathic manipulative medicine reduces length of hospital stays for pneumonia patients: Research

GTx reports top line results from toremifene Phase III clinical trial for prostate cancer

Rockwell Medical's SFP Phase IIb data accepted for presentation at XLVII ERA-EDTA Congress

FDA grants priority review for Alkermes' VIVITROL sNDA for opioid dependence

DAPT Study expands into seven countries in the EU: HCRI

Preclinical results of AMEP for metastatic melanoma presented at ASGCT Annual Meeting

Neuralstem updates progress of ongoing Phase I human clinical trial for ALS

Positive results from Phase 2 clinical trial for STA-9090 in Stage IIIB and Stage IV patients with NSCLC

Media outlets highlight studies presented at International Microbicides Conference

Enrollment in phase II clinical trial of brentuximab vedotin for ALCL completed

Ortho-McNeil Pharmaceutical pleads guilty for promoting epilepsy drug Topamax for psychiatric use

Phase 1 clinical trial of OXY111A initiated

Volcano to highlight extensive pipeline of imaging and therapy products at EuroPCR 2010

Sensing a Healthier Future

Achieving and maintaining ISO/IEC 27001 and BS 10012 certifications

Expanding research and clinical options for children with cancer

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