Efficacy News and Research

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FDA hearing on breast cancer drug set for this week

Genentech, the maker of Avastin, will appeal to the Food and Drug Administration to make its drug available as a treatment for breast cancer — asking for one more chance to prove its efficacy.

28 Jun 2011

Circulation journal publishes Celladon's MYDICAR Phase 2 trial on advanced heart failure

Celladon Corp., a biopharmaceutical company focused on the discovery and development of innovative treatments for cardiovascular diseases, announces that the data from its completed Phase 2 CUPID clinical study of MYDICAR for the treatment of advanced heart failure is being published today online in Circulation, an American Heart Association journal.

28 Jun 2011

Positive preliminary results from Anacor's AN2728 Phase 2b trial on psoriasis

Anacor Pharmaceuticals announced today preliminary results from its Phase 2b trial of AN2728 for the treatment of mild-to-moderate plaque-type psoriasis.

28 Jun 2011

ASP unveils innovative healthcare environmental infection prevention technology

Sterilization Products (ASP) announced today the launch of an innovative infection prevention technology – GLOSAIR Healthcare Environmental Decontamination – that provides effective, safe and thorough disinfection of hospital rooms and operating suites to reduce the risk of patient contact with infection-causing pathogens.

27 Jun 2011

EnVivo initiates EVP-0962 GSM Phase 1 clinical trial for Alzheimer’s disease

EnVivo Pharmaceuticals, a company dedicated to developing a broad range of novel central nervous system (CNS) therapies, announced today that it recently initiated a Phase 1 clinical trial of EVP-0962, its potent and selective gamma secretase modulator (GSM), in healthy volunteers.

27 Jun 2011

FDA responds to EpiCept Ceplene SPA

EpiCept Corporation today announced that it has received initial written responses from the U.S. Food and Drug Administration regarding the Company's application for a Special Protocol Assessment (SPA) of the Ceplene (histamine dihydrochloride) Phase III protocol.

27 Jun 2011

Spectranetics initiates enrollment in EXCITE clinical trial against femoropopliteal IRS

Spectranetics Corporation today announces the first patient enrollment in the EXCITE ISR (EXCImer Laser Randomized Controlled Study for Treatment of FemoropopliTEal In-Stent Restenosis) clinical trial.

27 Jun 2011

Yissum, BioLineRx sign license deal to develop and commercialize BL-7040 for IBD

BioLineRx, a biopharmaceutical drug development company, and Yissum Research Development Company Ltd., the Technology Transfer Company of the Hebrew University of Jerusalem, announced today that they have signed a worldwide, exclusive license agreement for BioLineRx to develop and commercialize BL-7040, an orally available Phase II ready molecule for treating Inflammatory Bowel Disease (IBD) and other inflammatory diseases.

27 Jun 2011

Enrollment complete in ERYTECH Pharma's Graspa Phase I clinical trial for pancreatic cancer

ERYTECH Pharma has just completed the enrollment of patients in a Phase I clinical trial with its flagship product for pancreatic cancer, Graspa®. This product contains the enzyme L-asparaginase encapsulated in red blood cells, using technology owned by ERYTECH Pharma.

27 Jun 2011

Positive data from Lyxumia study on type 2 diabetes presented at ADA 2011

Sanofi announced today data from four studies of its once-daily GLP-1 receptor agonist Lyxumia that is in Phase III clinical development, including data that demonstrates positive results in type 2 diabetes patients not at goal on oral therapies or with basal insulin.

27 Jun 2011

Video monitors on public buses to help raise HIV testing awareness among African Americans

A University of Pennsylvania study will determine if public transit can convey more than people going from point A to point B. Video displays on public buses in Los Angeles will be used to help determine the efficacy of an innovative soap opera-like video program designed to increase HIV testing among low-income African Americans 14 to 24 years of age.

27 Jun 2011

Positive preliminary findings from ATI's neurostimulation system study on cluster headache

Autonomic Technologies, Inc. (ATI), the developer of a novel miniaturized implantable system for severe headaches, today announced positive preliminary findings from a study evaluating the safety and efficacy of the company's investigational neurostimulation system for the treatment of cluster headache.

27 Jun 2011

Mortality, morbidity rates linked with AF remain 'unacceptably high' despite new treatments

Despite recent advances in the treatment of heart rhythm disturbances, mortality and morbidity rates associated with atrial fibrillation (AF) remain "unacceptably high", according to a new report.

27 Jun 2011

New model estimates impact of lifestyle changes on absolute breast cancer risk

How much can a woman lower her risk of breast cancer by losing weight, drinking less, or exercising more? A study published online June 24 in the Journal of the National Cancer Institute describes a new model to estimate the impact of these lifestyle changes on absolute breast cancer risk, suggesting risk reductions that could translate into a substantial number of prevented cancers across an entire population.

27 Jun 2011

Intravenous diclofenac holds promise against severe pain following oral surgery

An essential aspect of oral surgery is controlling the patient's pain following a procedure. The goal is to relieve pain and promote a rapid recovery, without opioid side effects. An initial study shows that Dyloject, a new intravenous form of the drug diclofenac, has promise for achieving these goals.

27 Jun 2011

Diabetic patients can benefit from basal insulin analogs

Basal insulin analogs have revolutionized diabetes care, and especially the treatment of type 2 diabetes, enabling patients to achieve better control of blood glucose levels while reducing hypoglycemic episodes.

27 Jun 2011

Short-term lowering of PreDx DRS may reduce risk of developing diabetes

Data presented today from an analysis of samples from the European Diabetes Prevention Study (EDIPS) showed that the PreDx Diabetes Risk Score (DRS) is lowered by lifestyle intervention, which correlates to a reduction in the risk that patients will develop diabetes over time.

27 Jun 2011

New data from Zafgen's ZGN-433 Phase 1b study on obesity presented at ADA 2011

Zafgen, Inc., a pharmaceutical company pioneering novel obesity therapeutics to help the body regain and sustain a lean, healthy state by targeting imbalances in fat metabolism, today announced new data from a Phase 1b study of ZGN-433, a selective methionine aminopeptidase 2 inhibitor (MetAP2), which showed a significant improvement in cardiovascular risk markers in severely obese subjects.

27 Jun 2011

EMA CHMP recommends approval of linagliptin for type 2 diabetes

Boehringer Ingelheim and Eli Lilly and Company today received a positive opinion from the European Medicines Agency's (EMA) medicinal committee recommending approval of linagliptin, 5 mg, film-coated tablets (to be marketed under the trade name Trajenta® in Europe) for the treatment of adults with type 2 diabetes.

24 Jun 2011

Scientific evidence is key driver for gaining reimbursement for MR-guided focused ultrasound

Medical researchers have a critical role to play in gaining optimal health insurance reimbursement for MR-guided focused ultrasound. As Susan Klees, Director of Patient Access for the Focused Ultrasound Surgery Foundation, reports, "Scientific evidence is the key driver for reimbursement, and it all begins with the way studies are designed. Today, research priorities must be grounded in sound science as well as the realities of the marketplace."

24 Jun 2011

Efficacy News and Research

FDA hearing on breast cancer drug set for this week

Circulation journal publishes Celladon's MYDICAR Phase 2 trial on advanced heart failure

Positive preliminary results from Anacor's AN2728 Phase 2b trial on psoriasis

ASP unveils innovative healthcare environmental infection prevention technology

EnVivo initiates EVP-0962 GSM Phase 1 clinical trial for Alzheimer’s disease

FDA responds to EpiCept Ceplene SPA

Spectranetics initiates enrollment in EXCITE clinical trial against femoropopliteal IRS

Yissum, BioLineRx sign license deal to develop and commercialize BL-7040 for IBD

Enrollment complete in ERYTECH Pharma's Graspa Phase I clinical trial for pancreatic cancer

Positive data from Lyxumia study on type 2 diabetes presented at ADA 2011

Video monitors on public buses to help raise HIV testing awareness among African Americans

Positive preliminary findings from ATI's neurostimulation system study on cluster headache

Mortality, morbidity rates linked with AF remain 'unacceptably high' despite new treatments

New model estimates impact of lifestyle changes on absolute breast cancer risk

Intravenous diclofenac holds promise against severe pain following oral surgery

Diabetic patients can benefit from basal insulin analogs

Short-term lowering of PreDx DRS may reduce risk of developing diabetes

New data from Zafgen's ZGN-433 Phase 1b study on obesity presented at ADA 2011

EMA CHMP recommends approval of linagliptin for type 2 diabetes

Scientific evidence is key driver for gaining reimbursement for MR-guided focused ultrasound

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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