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Failure in Medical Technology

National Cancer Institute Research Identifies Unique Mechanism of Brostallicin's Anti-Tumor Effectiveness

... including, without limitation, the potential failure of the preclinical results to predict results in clinical trials, the failure of the mechanism to be receptive to brostallicin's tumor cell killing profile, the failure of the bio-marker to guide clinical trials, the ...

Leading Experts Endorse Bioheart's Muscle Stem Cell MyoCell Therapy

... stem cell (myoblast) therapy for treating heart failure to mainstream use with FDA approval and CMS ... transplantation to patients with congestive heart failure and specifically to scar tissue (not living ... advantage over other cell types in treating heart failure as they can survive in low oxygen environments ...

SIMPONI(TM) (golimumab) Receives Positive Opinion From CHMP for Once-Monthly Subcutaneous Treatment of Rheumatoid Arthritis, Psoriatic Arthritis and Ankylosing Spondylitis

... in patients with moderate or severe heart failure (NYHA Class III/IV), as well as in patients who ... heavy smoking. Worsening congestive heart failure (CHF) and increased mortality due to CHF have ... be used with caution in patients with mild heart failure and must be discontinued if new or worsening ...

West Wireless Health Institute Teams with Corventis for its First Multicenter, Randomized Clinical Trial

... to prevent hospital readmissions for heart failure SAN DIEGO, June 24 /PRNewswire-USNewswire/ ... ) Congestive heart failure is the leading reason for hospital admission in ... of Innovative Medicine. "Congestive heart failure is one of the largest and most problematic ...

New Therapy Found to Prevent Heart Failure

... demonstrated a 29 percent reduction in heart failure or death in patients with heart disease who ... end point - significant reduction in heart failure or death with CRT-D versus ICD-only. Cardiologist ... approved for use in patients with severe heart failure (New York Heart Association class III/IV), where ...

MADIT-CRT Trial Meets Primary Endpoint

... Scientific CRT-Ds slow the progression of heart failure in asymptomatic and mildly symptomatic patients ... 29 percent reduction (p=0.003) in death or heart failure interventions when compared to traditional ... eventually lead to a wider population of heart failure patients being treated with CRT-D therapy," said ...

Responses After Completion of Therapy Increase Pixantrone Complete Remission (CR)/Unconfirmed Complete Remission (CRu) Rate to 24% and Overall Response Rate (ORR) to 40% Compared to 7% and 14% for Comparator Agents in Phase III EXTEND Trial in 3rd Line Th

... heart damage that may result in congestive heart failure many years later. As a result, there is a ... including, without limitation, the potential failure of pixantrone to prove safe and effective (including the failure to achieve the overall response rate, complete ...

DOR BioPharma Receives EMEA Agreement on the Design of its Confirmatory Phase 3 Clinical Trial of orBec(R) in GI GVHD

... patients. The primary endpoint is the treatment failure rate at Study Day 80. This endpoint was ... With our primary endpoint of the 'treatment failure rate at Study Day 80,' we expect to replicate ... pivotal trial, namely median time-to-treatment failure through Day 50 (p-value 0.1177), orBec(R) did ...

Afinitor(R) Phase II Data Show Positive Results for Patients With Multiple Types of Lymphoma, Leading to Phase III Trial

... mg tablets) to treat advanced kidney cancer after failure of treatment with sunitinib or sorafenib. ... Deaths due to acute respiratory failure (0.7%), infection (0.7%) and acute renal failure (0.4%) were observed in patients receiving ...

Pixantrone in Combination with Chemotherapy Regimens Produces Overall Response Rates of 58-74% with Complete Remission Rates of 37-57% in Relapsed/Refractory Aggressive or Indolent NHL

... heart damage that may result in congestive heart failure many years later. As a result, there is a ... including, without limitation, the potential failure of pixantrone to prove safe and effective for ... aggressive NHL as determined by the FDA, the failure of pixantrone to have a low cardiotoxicity ...

Large, Long-Term Study Shows Avandia Has No Increased Overall Cardiovascular Risk Compared to Other Commonly Used Diabetes Medicines

... of diabetes that can lead to amputations, kidney failure and eye damage. Congestive heart failure is a known effect of Avandia and other drugs in ... heart disease, stroke, eye damage, kidney failure and foot problems that lead to amputations. ...

New One-Year Data from REMICADE(R) SONIC Trial Show Sustained Efficacy Compared with Azathioprine in Treatment of Crohn's Disease

... or had phototherapy for psoriasis. Heart failure or any heart condition. Many people with heart failure should not take REMICADE. Hepatitis B ... azathioprine or 6-mercaptopurine. Heart failure - new or worsening symptoms, such as shortness of ...

Pixantrone Produces High Rates of Complete and Partial Remissions Even Among Aggressive NHL Patients With Extensive Prior Doxorubicin Treatment or Prior Rituximab Treatment

... and only one patient developed congestive heart failure (CHF). The total cumulative doxorubicin ... heart damage that may result in congestive heart failure many years later. As a result, there is a ... including, without limitation, the potential failure of pixantrone to prove safe and effective (or ...

Results and Additional Analyses From Study Show That Corthera's Relaxin for Acute Heart Failure is the Strongest Predictor of Improved Longer-Term Outcomes Following Hospital Discharge When Compared to Other Variables

... Data from Phase II/III Study Presented at Heart failure Congress 2009 Demonstrate Promising Safety and ... drug for the treatment of acute heart failure (AHF), was the strongest independent predictor of ... trials session at the annual meeting of the Heart failure Association of the European Society of Cardiology ...

Induction Chemotherapy Followed by ChemoRadiotherapy Increased Time-to-Treatment Failure Compared to ChemoRadiotherapy Alone in Patients With Unresectable Locally Advanced Head & Neck Cancer

... significantly increased time-to-treatment failure in comparison to standard ChemoRadiotherapy alone ... alone, significantly prolonged Time-to-Treatment failure (TTF) for patients with unresectable Locally ... Cancer (LAHNC). The endpoint of Time-to-Treatment failure was defined as a composite of time-to-disease ...

Celladon Provides MYDICAR(R) Program Update of First-In-Human Trial for Advanced Heart Failure at American Society of Gene Therapy Annual Meeting

... efficacy parameters important in assessing heart failure status. Efficacy was defined as the mean ... has placed gene-based therapy for heart failure within reach and yielded valuable insights for ... currently enrolling patients with advanced heart failure at 17 U.S. medical centers. Zsebo adds, "We ...

Results and Additional Analyses From Efficacy and Safety Study of Corthera's Relaxin in Acute Heart Failure to be Presented at Heart Failure Congress 2009

... drug relaxin for the treatment of acute heart failure will be presented at the Heart failure Congress, the annual meeting of the Heart failure Association of the European Society of Cardiology ...

Video: Data on More Than 15 Novartis Oncology Compounds at ASCO Highlight Progress Toward Targeted Therapies for Diverse Tumor Types

... patients with advanced renal cell carcinoma after failure of treatment with sunitinib or sorafenib. ... Deaths due to acute respiratory failure (0.7%), infection (0.7%) and acute renal failure (0.4%) were observed in patients receiving ...

Celladon Corporation Announces Presentation of First-in-Human Gene Transfer to Treat Heart Failure at the 12th Annual Meeting of the American Society of Gene Therapy

... Center. "A key underpinning of heart failure is the depletion of SERCA2a enzyme in heart ... gene transfer technology, have placed heart failure within reach of gene-based therapy. A Phase 1/2 ... trial of enzyme replacement therapy in heart failure using AAV and has demonstrated acceptable safety ...

MitraClip(R) Therapy Data Demonstrate Clinical Benefit in High-Risk Patients With Mitral Regurgitation

... rate of Hospitalization for Congestive Heart failure in both Functional and Degenerative MR Patient ... and reduced hospitalization for congestive heart failure for both MR groups at twelve months. ... of life, are frequently hospitalized for heart failure and have reduced survival. The High Risk ...

Terumo Heart, Inc. Reaches Clinical Milestone as the 100th Patient Worldwide Receives the DuraHeart(TM) Left Ventricular Assist System

... weeks leading up to this major milestone, heart failure centers in Europe and the U.S. were kept up to ... is an excellent tool to treat our end-stage heart failure patients who are no longer capable of pumping ... visit www.terumoheart.com . About Heart failure More than 22 million people suffer from ...

FDA Approves Vanda Pharmaceuticals' Fanapt(TM) for the Treatment of Schizophrenia

... in the completion of Vanda's clinical trials; a failure of Vanda's products to be demonstrably safe and effective; Vanda's failure to obtain regulatory approval for its products or ... of Vanda's products in the marketplace, or a failure to become or remain profitable; Vanda's ...

Genes Identified That Enhance Tumor Cell Sensitivity to CTI's Cancer Drug Brostallicin

... including, without limitation, the potential failure of the preclinical results to predict results in clinical trials, the potential failure of the clinical results to predict the safe and effective treatment of cancer, the potential failure of brostallicin to prove safe and effective for ...

Glycotex' Investigational Compound GLYC-101 Achieves Accelerated Wound Closure Based on Interim Analysis

... uncertainties, including, but not limited to, our failure to successfully commercialize our product ... in the development and/or FDA approval, or the failure of our products to obtain such approval; ... of others; general economic conditions; the failure of any products to gain market acceptance; our ...

Study Data Show Positive European Experience With DuraHeart Left Ventricular Assist Device for Advanced Stage Heart Failure Patients

... acceptable adverse event rate in advanced heart failure patients who were eligible for transplantation. ... All patients were classified with end-stage heart failure and were on approved lists to receive donor ... risk of death due to end-stage left ventricular failure and eligible for heart transplantation, the ...

Video: Afinitor(R) Approved in US as First Treatment for Patients With Advanced Kidney Cancer After Failure of Either Sunitinib or Sorafenib

... with advanced renal cell carcinoma (RCC) after failure of treatment with Sutent(R) (sunitinib)* or ... mg tablets) to treat advanced kidney cancer after failure of treatment with sunitinib or sorafenib. In ... Deaths due to acute respiratory failure (0.7%), infection (0.7%) and acute ...

Results From Study Show Promising Efficacy and Safety Results for Corthera's Relaxin in Acute Heart Failure

... investigational drug for treatment of acute heart failure (AHF). The report containing the detailed study ... hospital course of patients, prevention of heart failure worsening during hospitalization, shortening of ... has been an epidemic of hospitalization for heart failure and there is a great need for an advance in the ...

Impulse Dynamics Announces Pivotal Results at the American College of Cardiology Annual Meeting Late-Breaking Session

... by a reduction in the Minnesota Living with Heart failure score (p<0.0001). Although the results did ... the potential of CCM as a therapy for heart failure patients with no other options," said Dr. William ... therapy for a greatly underserved group of heart failure patients. We have a clear pathway for further ...

MitraClip(R) Therapy Data Shows Important Clinical Benefit in High Risk Patients With Functional Mitral Regurgitation at 12-Month Follow Up

... of life, are frequently hospitalized for heart failure and have reduced survival. The FMR high-risk ... function. The rate of hospitalization for heart failure in the year after treatment with the MitraClip(R) ... observed decrease in hospitalization for heart failure in this population could have an important ...

David Feldman, M.D. Appointed Co-Principal Investigator of DuraHeart(TM) Left Ventricular Assist System U.S. Clinical Trial

... this role. Dr. Feldman is Director of Heart failure and Cardiac Transplantation and Director of Heart failure and Transplant Fellowship Program at The Ohio ... and the School of Pharmacy. A renowned heart failure cardiologist, Dr. Feldman holds numerous ...

First Swiss Patients Treated with the Percutaneous MitraClip(R) System

... M.D., Ph.D. "Until now, many heart failure patients with associated functional MR had no ... Professor Auricchio, Director of the Heart failure Clinic commented: "Heart failure is a devastating disease, significantly more ...

Terumo Heart, Inc. Reports Clinical Progress in the DuraHeart(TM) U.S. Pivotal Trial as NewYork-Presbyterian Hospital/Columbia University Medical Center Implants First Patient

... total flow to normal levels. About Heart failure More than 22 million people suffer from heart failure worldwide with approximately one million new ... the setting of an aging global population, heart failure is the number one reason for hospitalization. ...

Nektar Announces Positive Results from Phase 2 Study of Oral NKTR-118 in Patients with Opioid-Induced Constipation (OIC)

... in mid-stage clinical development and the risk of failure remains high and failure can unexpectedly occur at any stage prior to ... standards of care, clinical outcomes, or delay or failure in obtaining regulatory approval in one or more ...

Savient Provides Update on Pegloticase BLA

... in treating patients who suffer from treatment failure gout," said Paul Hamelin, President. Key ... include, but are not limited to, the delay or failure in completing development of pegloticase and ... and CMC data by the FDA; delay achieving or failure to achieve FDA approval of pegloticase; inability ...

CVS Caremark Study Finds Non-Adherent Heart Failure Patients Almost Twice as Likely to be Re-Hospitalized Within a Year

... nearly half of patients hospitalized for heart failure may not be adherent to recommended drug ... conditions, medication adherence for heart failure patients is a significant driver of both long ... The study examined adherence to key heart failure medications (ACE/ARBs, beta-blockers and ...

Cardio3 BioSciences Raises EUR13.7 Million in Series B Fundraising and Grant Funding

... a Second-Generation Cell-Based Therapy for Heart failure Cardio3 BioSciences, a leading Belgian ... could fundamentally change the future of heart failure patients, one of the world's largest medical ... like C-Cure to improve the treatment of heart failure is evidenced by the fact that its clinical ...

Study Finds DOXIL(R) Combination Therapy Delays Disease Progression for Patients With Metastatic Breast Cancer

... events). Symptomatic congestive heart failure was reported in 1% of subjects in both groups. ... AIDS-related Kaposi's sarcoma in patients after failure of prior systemic chemotherapy or intolerance to ... damage may lead to congestive heart failure and may occur as the total cumulative dose ...

Video: Tasigna(R) Demonstrates Rapid Response as Initial Therapy in Life-Threatening Form of Leukemia

... phase (AP), or in the chronic phase (CP) after failure of interferon-alpha therapy. Gleevec ... in the elderly. Severe congestive heart failure and left ventricular dysfunction have ... with cardiac disease or risk factors for cardiac failure should be monitored carefully, and any patient ...

Observational Study Finds Changes in Medicare Reimbursement for Erythropoiesis-Stimulating Agents Associated With Increased Need for Blood Transfusion

... cancer receiving chemotherapy, with chronic renal failure who are on dialysis and those who are not on ... Patients with chronic renal failure experienced greater risks for death and serious ... Dose of PROCRIT Chronic renal failure patients: The dose of PROCRIT should be titrated ...

More Than 200 Abstracts at ASH and SABCS Reveal Potential Compelling Patient Benefits From Novartis Oncology Current and Pipeline Therapies

... phase (AP), or in the chronic phase (CP) after failure of interferon-alpha therapy. Fetal harm ... in the elderly. Severe congestive heart failure and left ventricular dysfunction have ... with cardiac disease or risk factors for cardiac failure should be monitored carefully, and any patient ...
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(Date:7/11/2014)... German . ... the refraction of X-rays through a specimen instead of ... method are often of much higher quality than those ... Prof. Franz Pfeiffer are particularly interested in developing new ... X-ray phase-contrast imaging. One main goal is to make ...
(Date:7/11/2014)... Shenzhen, July 10, 2014---A team of researchers from The ... have identified a gene of wild soybean linked to ... to grow in saline soil. This study published online ... to unveil novel genomic information for crop improvement. , ... to domestication and human selection, cultivated soybeans have less ...
(Date:7/11/2014)... An international team of researchers, including scientists from the ... just a reported a major step in understanding photosynthesis, ... now maintains the oxygen in its atmosphere and which ... on earth. , The researchers report the first ... reaction, namely the step in which a specific protein ...
Breaking Biology News(10 mins):New simple setup for X-ray phase contrast 2BGI reports a novel gene for salt tolerance found in wild soybean 2A first direct glimpse of photosynthesis in action 2
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(Date:7/11/2014)... July 11, 2014 The American Association ... 55 poison centers are commending Senator Bill Nelson (D-FL) ... Act of 2014 on July 10, 2014. Along with ... Products Safety Commission (CPSC) to enact rules requiring safer, ... , Senate co-sponsors of the bill include: ...
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