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Melphalan granted FDA Orphan Drug Designation for treatment of cholangiocarcinoma

Delcath Systems, Inc., a specialty pharmaceutical and medical device company focused on oncology with an emphasis on the treatment of primary and metastatic liver cancers, announced today that the U.S. Food and Drug Administration Office of Orphan Products Development has granted Orphan Drug Designation for melphalan for the treatment of cholangiocarcinoma.

20 Jul 2015

IAOCR announces pilot Clinical Operations Workforce Quality Accreditation at organizational level

IAOCR, the leading provider of independently recognized, competence-based accreditation, consultancy and accredited training within the clinical research sector, is pleased to announce the pilot Clinical Operations Workforce Quality Accreditation, achievement of which will serve as a quality mark for clinical operations workforce excellence. Leading contract research organization (CRO) INC Research is the first to participate in the pilot, introduced to industry specialists at the annual IAOCR Clinical Research Industry Leaders Think Tank in June.

20 Jul 2015

HeartWare announces initiation of MVAD System CE Mark international clinical trial

HeartWare International, Inc., a leading innovator of less invasive, miniaturized circulatory support technologies that are revolutionizing the treatment of advanced heart failure, today announced commencement of its MVAD System CE Mark international clinical trial.

20 Jul 2015

Transcranial magnetic stimulation holds promise for tinnitus patients

In the largest U.S. clinical trial of its kind funded by the Veterans Affairs Rehabilitation Research and Development Service, researchers at the VA Portland Medical Center and Oregon Health & Science University found that transcranial magnetic stimulation significantly improved tinnitus symptoms for more than half of study participants.

17 Jul 2015

Increased radiation dose offers survival benefit for men with medium- and high-risk prostate cancer

Increased radiation dose is associated with higher survival rates in men with medium- and high-risk prostate cancer, but not men with low-risk prostate cancer, according to a new study from Penn Medicine published this week in JAMA Oncology. Already-high survival rates for men with low-risk prostate cancer were unaffected by higher radiation dosages compared to lower radiation dosages.

17 Jul 2015

Novel cancer drug candidate developed in Singapore advances into clinical trials

A made-in-Singapore cancer drug has advanced into clinical trials, charting a milestone in Singapore's biomedical sciences initiative that will go towards improving the lives of cancer patients in Singapore, and worldwide.

17 Jul 2015

Novogen's Anisina granted FDA Orphan Drug Designation for neuroblastoma

US-Australian drug discovery company, Novogen Limited, today announced that it has received notification from the U.S. Food and Drug Administration that its chemotherapy candidate drug, Anisina, has been granted Orphan Drug Designation for neuroblastoma.

16 Jul 2015

Gene therapy used for sight restoration also strengthens visual pathways in the brain

Since 2007, clinical trials using gene therapy have resulted in often-dramatic sight restoration for dozens of children and adults who were otherwise doomed to blindness. Now, researchers from the Perelman School of Medicine at the University of Pennsylvania and The Children's Hospital of Philadelphia, have found evidence that this sight restoration leads to strengthening of visual pathways in the brain, published this week in Science Translational Medicine.

16 Jul 2015

NuSI launches groundbreaking clinical study to halt nonalcoholic fatty liver disease in children

Nutrition Science Initiative has launched the first-ever randomized, controlled clinical trial to determine whether removing added sugars from the diet can halt or even reverse nonalcoholic fatty liver disease (NAFLD) in children.

16 Jul 2015

New drug DSM265 shows potential to cure, prevent malaria

Researchers at UT Southwestern Medical Center and in Australia have shown that a drug currently in testing shows potential to cure malaria in a single dose and offers promise as a preventive treatment as well.

16 Jul 2015

Futura Medical develops new generation of topical pain relief

Futura Medical has developed a "new generation" of topical pain relief with two products that target more active ingredients directly to the point of pain. The new products have the potential to transform the pain relief market, according to chief executive James Barder.

15 Jul 2015

Gene therapy provides life-long protection to photoreceptor cells in animal model of retinitis pigmentosa

A collaboration between scientists in the UK and the USA has shown that gene therapy can give life-long protection to the light-sensitive photoreceptor cells responsible for colour vision in a mouse model of the most common inherited eye disorder.

15 Jul 2015

Lower-intensity summerMAX treatment equally effective as high-intensity for children with HFASD

Researchers at the Institute for Autism Research at Canisius College have found that reducing the intensity of their comprehensive summer treatment (summerMAX) yielded improvements for high-functioning children with autism spectrum disorder (HFASD) that were comparable to the original high-intensity program.

15 Jul 2015

Study examines how low-methionine diet may help improve outcomes in triple-negative breast cancer patients

A diet that starves triple-negative breast cancer cells of an essential nutrient primes the cancer cells to be more easily killed by a targeted antibody treatment, UW Carbone Cancer Center scientists report in a recent publication.

15 Jul 2015

Hyperbaric oxygen treatment effective for fibromyalgia

Fibromyalgia is almost impossible to diagnose. The chronic pain syndrome strikes an estimated 1 in 70 Americans, most of them women. The disorder is often triggered by head trauma, a neurological infection, or severe emotional stress, and is characterized by symptoms such as musculoskeletal pain, fatigue, memory loss and mood swings. Fibromyalgia is often mistaken for other culprits and most patients suffer months, even years, of unrelenting pain before being properly diagnosed. And once diagnosed, patients enjoy little respite because few therapies have been found to be effective in assuaging its symptoms.

15 Jul 2015

Ferrer begins Lorediplon phase IIa trial in patients with insomnia disorder

Ferrer, a privately-held Spanish pharmaceutical company, today announces the first patient has been recruited into a phase IIa clinical trial to test the efficacy, safety and tolerability profile of Lorediplon in adult patients with insomnia disorder. The study is scheduled to be completed by Q4, 2016.

14 Jul 2015

Two antioxidant supplements effective in treating mice with skin-picking disorder

Two antioxidant supplements are effective in treating skin-picking disorder in mice, according to a study led by a Stanford University School of Medicine researcher.

14 Jul 2015

Cedars-Sinai's groundbreaking online registry improves participation in clinical research

Research for Her, Cedars-Sinai's groundbreaking online registry that matches women with research studies and clinical trials, enrolled study participants more quickly when compared with traditional paper-based registries, according to new research published in the journal Gynecologic Oncology.

14 Jul 2015

OncoGenex's custirsen Phase 3 ENSPIRIT trial for treatment of NSCLC patients continues as planned

OncoGenex Pharmaceuticals, Inc. announced today that its Phase 3 ENSPIRIT trial evaluating custirsen in the treatment of advanced or metastatic non-small cell lung cancer (NSCLC) is continuing as planned per the recommendation of an Independent Data Monitoring Committee (IDMC). This decision was based upon completion of the second and final planned interim futility analysis.

13 Jul 2015

Canadian researchers launch world's first viral therapy clinical trial to attack and kill cancer cells

Canadian researchers have launched the world's first clinical trial of a novel investigational therapy that uses a combination of two viruses to attack and kill cancer cells, and stimulate an anti-cancer immune response. Previous research by this team and others worldwide suggests that this approach could be very powerful, and could have fewer side effects than conventional chemotherapy and radiation, although it will take years to rigorously test through this trial and others.

13 Jul 2015

Clinical Trial News and Research

Melphalan granted FDA Orphan Drug Designation for treatment of cholangiocarcinoma

IAOCR announces pilot Clinical Operations Workforce Quality Accreditation at organizational level

HeartWare announces initiation of MVAD System CE Mark international clinical trial

Transcranial magnetic stimulation holds promise for tinnitus patients

Increased radiation dose offers survival benefit for men with medium- and high-risk prostate cancer

Novel cancer drug candidate developed in Singapore advances into clinical trials

Novogen's Anisina granted FDA Orphan Drug Designation for neuroblastoma

Gene therapy used for sight restoration also strengthens visual pathways in the brain

NuSI launches groundbreaking clinical study to halt nonalcoholic fatty liver disease in children

New drug DSM265 shows potential to cure, prevent malaria

Futura Medical develops new generation of topical pain relief

Gene therapy provides life-long protection to photoreceptor cells in animal model of retinitis pigmentosa

Lower-intensity summerMAX treatment equally effective as high-intensity for children with HFASD

Study examines how low-methionine diet may help improve outcomes in triple-negative breast cancer patients

Hyperbaric oxygen treatment effective for fibromyalgia

Ferrer begins Lorediplon phase IIa trial in patients with insomnia disorder

Two antioxidant supplements effective in treating mice with skin-picking disorder

Cedars-Sinai's groundbreaking online registry improves participation in clinical research

OncoGenex's custirsen Phase 3 ENSPIRIT trial for treatment of NSCLC patients continues as planned

Canadian researchers launch world's first viral therapy clinical trial to attack and kill cancer cells

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