Clinical Trial News and Research

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VirtualScopics signs software licence, support agreement with IXICO

VirtualScopics, Inc., a leading provider of clinical trial imaging solutions, today announced that they have signed a multi-year software licence and support agreement with existing alliance partner, IXICO plc, the brain health company, for their proprietary imaging data and query management digital platform, TrialTracker™.

16 Dec 2014

CVRx receives HDE approval for Barostim neo legacy device

CVRx, Inc., a privately held medical device company, announced today that it has received Humanitarian Device Exemption (HDE) approval from the U.S. Food and Drug Administration for its Barostim neo legacy device.

16 Dec 2014

Novartis announces FDA approval of Signifor LAR for treatment of patients with acromegaly

Novartis announced today that the US Food and Drug Administration has approved Signifor long-acting release (LAR) (pasireotide) for injectable suspension, for intramuscular use, for the treatment of patients with acromegaly who have had an inadequate response to surgery and/or for whom surgery is not an option.

16 Dec 2014

Two-drug combination before surgery benefits women with triple-negative breast cancer

A breast cancer specialist and clinical researcher at Women & Infants Hospital of Rhode Island presented research yesterday at the 2014 San Antonio Breast Cancer Symposium showing that adding either the chemotherapy drug carboplatin or the blood vessel-targeting drug bevacizumab to the standard treatment of chemotherapy before surgery helped women who have the basal-like subtype of triple-negative breast cancer.

15 Dec 2014

Novel marker may help doctors choose most effective treatment for older patients with AML

A new study led by researchers at The Ohio State University Comprehensive Cancer Center - Arthur G. James Cancer Hospital and Richard J. Solove Research Institute describes a novel marker that might help doctors choose the least toxic, most effective treatment for many older patients with acute myeloid leukemia (AML).

15 Dec 2014

Tendyne Feasibility Study: Tendyne successfully implants TMVI system in first patient

Tendyne Holdings, Inc., a privately held clinical stage medical device company, announced today that in November 2014 the Tendyne Transcatheter Mitral Valve Implantation system (TMVI) was successfully implanted in the first patient of the Tendyne Feasibility Study. This was the first patient enrolled in a three continent, multicenter trial, which aims to generate insight into the safety and performance of the Tendyne device in inoperable patients suffering from mitral regurgitation.

15 Dec 2014

Anavex Life Sciences qualifies to trade on OTCQX

OTC Markets Group Inc., operator of Open, Transparent and Connected financial marketplaces, today announced that Anavex Life Sciences Corp., a clinical-stage biopharmaceutical company developing novel drug candidates to treat Alzheimer's disease, other diseases of the central nervous system (CNS), and various types of cancer, has qualified to trade on OTCQX, the best marketplace for established, global and growth companies.

14 Dec 2014

TWi Biotechnology gets approval of Phase II clinical trial protocol for AC-201 CR tablets

TWi Pharmaceuticals, Inc. today announced that its fully owned subsidiary, TWi Biotechnology, Inc., has received US FDA and Taiwan FDA approval of a protocol for a Phase II clinical trial of its AC-201 controlled-release (CR) tablets for the indications of high blood uric acid level and gout.

14 Dec 2014

Oncotype DX assay linked to decrease in chemotherapy use in younger patients

In what's believed to be one of the largest population-based studies of Oncotype DX ever conducted, researchers at The University of Texas MD Anderson Cancer Center have found that the commercial diagnostic tool, Oncotype DX, was associated with a decrease in chemotherapy use in younger patients, but not in those over 66 years of age.

14 Dec 2014

Study sheds light on clinical and biological characteristics of male breast cancer

Results of the EORTC10085/TBCRC/BIG/NABCG International Male Breast Cancer Program conducted in both Europe and in the United States and presented at the 2014 San Antonio Breast Cancer Symposium found significant improvement in survival for men with breast cancer, but this improvement was not as good as that observed for women.

14 Dec 2014

ALS Association announces research funds to further understand genetic cause of ALS

The ALS Association is pleased to announce the award of $326,662 in research funds to expand ongoing natural history studies in order to further understand the most common genetic cause of ALS, in preparation for clinical trials in those whose disease is affected by this gene.

14 Dec 2014

Zylast selected as a winner of USAID Fighting Ebola Grand Challenge

Zylast products have been selected as one of only three initial winners of the USAID Fighting Ebola Grand Challenge. The announcement, made from the White House, introduces Zylast as a solution to "help healthcare workers on the front lines provide better care and stop the spread of Ebola."

14 Dec 2014

St. Jude Medical receives CE Mark approval for Quadra Allure MP CRT-P

St. Jude Medical, Inc., a global medical device company, today announced CE Mark approval of the Quadra Allure MP™ cardiac resynchronization therapy pacemaker (CRT-P).

13 Dec 2014

Danish researchers working on new type of vaccine that targets disease causing bacterium

When we acquire diarrhea on a vacation, it is often caused by a bacterial infection. Now a Danish research team is working on a new type of vaccine design targeting the disease causing bacterium - if it works it may very well revolutionize not only the prevention of this disease, but also offer protection against other pathogens with a heavy disease burden such as Mycobacterium tuberculosis and antibiotic-resistant Staphylococcus aureus (MRSA).

12 Dec 2014

New interoperability standards for diabetes devices

JDRF and the Centre for Global eHealth Innovation at the University Health Network in Toronto announced publication of interoperability standards for diabetes devices. The work is the result of JDRF Canadian Clinical Trial Network funding to Dr. Joseph Cafazzo at UHN to pilot the development of standard communication protocols that define how diabetes devices, such as insulin pumps, blood glucose meters, and continuous glucose monitors, communicate with one another and with other devices.

12 Dec 2014

First-line dacomitinib may improve advanced NSCLC survival

Preliminary research suggests that the second-generation tyrosine kinase inhibitor dacomitinib may improve progression-free survival in patients with advanced non-small-cell lung cancer with epidermal growth factor receptor mutations.

11 Dec 2014

FDA clears ArmaGen's AGT-182 IND application for treatment of Hunter syndrome

ArmaGen, Inc., a privately held biotechnology company focused on developing novel therapies to treat severe neurological disorders, announced today that the Investigational New Drug (IND) application for the company's lead product candidate, AGT-182 for the treatment of Hunter syndrome, has been accepted by the U.S. Food and Drug Administration and is now active.

11 Dec 2014

CVRx gets CE Mark approval to expand labeling of Barostim neo System as MR Conditional

CVRx, Inc., a privately held medical device company, announced today that CE Marking has been granted to expand labeling of the Barostim neo System as MR Conditional, or safe for use in Magnetic Resonance Imaging (MRI) systems under specified conditions.

11 Dec 2014

STSI researchers launch study to examine root cause of sudden unexpected death

Researchers at the Scripps Translational Science Institute have launched a clinical trial aimed at cracking one of the toughest mysteries in forensic science -- sudden unexplained death.

11 Dec 2014

New study reveals how COX-2 inhibitors can increase risk of heart attack in arthritis patients

A class of drug for treating arthritis - all but shelved over fears about side effects - may be given a new lease of life, following the discovery of a possible way to identify which patients should avoid using it.

11 Dec 2014

Clinical Trial News and Research

VirtualScopics signs software licence, support agreement with IXICO

CVRx receives HDE approval for Barostim neo legacy device

Novartis announces FDA approval of Signifor LAR for treatment of patients with acromegaly

Two-drug combination before surgery benefits women with triple-negative breast cancer

Novel marker may help doctors choose most effective treatment for older patients with AML

Tendyne Feasibility Study: Tendyne successfully implants TMVI system in first patient

Anavex Life Sciences qualifies to trade on OTCQX

TWi Biotechnology gets approval of Phase II clinical trial protocol for AC-201 CR tablets

Oncotype DX assay linked to decrease in chemotherapy use in younger patients

Study sheds light on clinical and biological characteristics of male breast cancer

ALS Association announces research funds to further understand genetic cause of ALS

Zylast selected as a winner of USAID Fighting Ebola Grand Challenge

St. Jude Medical receives CE Mark approval for Quadra Allure MP CRT-P

Danish researchers working on new type of vaccine that targets disease causing bacterium

New interoperability standards for diabetes devices

First-line dacomitinib may improve advanced NSCLC survival

FDA clears ArmaGen's AGT-182 IND application for treatment of Hunter syndrome

CVRx gets CE Mark approval to expand labeling of Barostim neo System as MR Conditional

STSI researchers launch study to examine root cause of sudden unexpected death

New study reveals how COX-2 inhibitors can increase risk of heart attack in arthritis patients

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