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FDA Advisory Committee recommends non-approval of liprotamase for exocrine pancreatic insufficiency

Eli Lilly and Company announced the U.S. Food and Drug Administration (FDA) Gastrointestinal Drugs Advisory Committee voted today to recommend non-approval of liprotamase, a non-porcine pancreatic enzyme replacement therapy (PERT), currently under FDA review for the treatment of exocrine pancreatic insufficiency (EPI).

13 Jan 2011

GSK, ChemoCentryx initiate '786 Phase III clinical trial for Crohn's disease

GlaxoSmithKline and ChemoCentryx, announced today that the first patient with Crohn's disease has initiated treatment in the initial pivotal induction study comparing Traficet-EN, now designated GSK1605786 ('786), to placebo.

12 Jan 2011

FDA panel rejects new pancreatic enzyme replacement drug

Eli Lilly & Co did not win the support of the U.S. advisory panel on Wednesday for its one-of-its kind drug not made from pig enzymes to help certain pancreatic patients digest food. A Food and Drug Administration panel of outside experts in a 7-4 vote said they were not convinced the experimental medicine, known chemically as liprotamase, worked well enough for patients to absorb enough needed nutrients. One member of the panel abstained.

12 Jan 2011

Endosense initiates enrollment in TactiCath Contact Force Ablation Catheter Study for Atrial Fibrillation

Endosense, a medical technology company focused on improving the efficacy, safety and accessibility of catheter ablation for the treatment of cardiac arrhythmias, has announced first patient enrollment in the TOCCASTAR (TactiCath Contact Force Ablation Catheter Study for Atrial Fibrillation) clinical study at Na Homolce Hospital, Prague, Czech Republic, by study investigator Petr Neuzil, M.D.

12 Jan 2011

Study shows delivering cancer drug in hydrophobic nanoparticle is a safe and effective prostate cancer therapy

Researchers at MIT and Brigham and Women's Hospital have shown that they can deliver the cancer drug cisplatin much more effectively and safely in a form that has been encapsulated in a nanoparticle targeted to prostate tumor cells and is activated once it reaches its target.

12 Jan 2011

UVA Cancer Center moves to OnCore Clinical Research Management System

The University of Virginia (UVA) NCI-designated Cancer Center recently made the move from a comparatively sophisticated home-grown clinical trials management system (CTMS) to the OnCore Clinical Research Management System (OnCore-CRM) from Forte Research Systems, Inc.

12 Jan 2011

Scientists find way to prevent early stage pancreatic cancer in research models

Cancer researchers at The Peggy and Charles Stephenson Oklahoma Cancer Center have found a way to stop early stage pancreatic cancer in research models - a result that has far-reaching implications in chemoprevention for high-risk patients.

12 Jan 2011

Epigenetic therapy holds promise for cancer management

Syndax, a clinical-stage epigenetics oncology company, announced publication of data of entinostat combined with the demethylating agent Vidaza® (azacitidine) showing effect in reducing tumor burden in differentiated tumor cells in animal tumor models of non-small cell lung cancer (NSCLC). The data is being published in the January 15, 2011 issue of Cancer Research.

12 Jan 2011

UH, Case Western University commence clinical trial for bipolar disorder

The Mood Disorders Program at Case Western Reserve University School of Medicine and University Hospitals Case Medical Center, along with the Bipolar Trials Network, is launching Bipolar CHOICE.

12 Jan 2011

Neurology professor receives MFRF's 'See the Light' award for Tay-Sachs research

Miguel Sena-Esteves, PhD, associate professor of neurology at the University of Massachusetts Medical School, was presented with the annual "See the Light" award from the Mathew Forbes Romer Foundation in recognition of his work for leading the fight against children's genetic diseases of the brain.

12 Jan 2011

Apixaban drug raises hope for DVT prevention in patients undergoing hip replacement surgery

A worldwide research consortium that includes the University of Oklahoma Health Sciences Center has proven that a new drug is more effective and easier to use than current medicines in the prevention of blood clots following hip replacement surgery.

12 Jan 2011

Herpes zoster vaccine reduces risk of developing shingles by 55%

Receiving the herpes zoster vaccine was associated with a 55 percent reduced risk of developing shingles, according to a Kaiser Permanente study of 300,000 people that appears in the current issue of the Journal of the American Medical Association.

12 Jan 2011

SCRI to lead clinical development of AstraZeneca's novel targeted oncology compound

AstraZeneca and Sarah Cannon Research Institute (SCRI), an international leader in advancing therapies for cancer patients through clinical research, today announced that SCRI will lead the clinical development of a novel targeted oncology compound from AstraZeneca.

12 Jan 2011

FemmePharma completes FP 1097 Phase II clinical trial in women with OAB

FemmePharma Global Healthcare, a privately held women's health company dedicated to improving the quality of life for women, today announces completion of its Phase II clinical dose ranging/safety trial with FP 1097 in women suffering from urinary incontinence or overactive bladder.

11 Jan 2011

SciClone initiates phase 2b study of SCV-O7 for oral mucositis

SciClone Pharmaceuticals, Inc. (NASDAQ: SCLN) today announced the enrollment of the first patient in the company's phase 2b clinical trial of SCV-07 for the prevention of oral mucositis (OM) -- a painful, debilitating, and costly toxicity caused by chemoradiotherapy regimens used to treat head and neck cancer.

11 Jan 2011

ALLOZYNE completes AZ01 Phase IA clinical trial in relapsing remitting multiple sclerosis

ALLOZYNE, Inc. announced today, the completion of its first Phase IA clinical trial in healthy individuals for AZ01, a PEGylated form of human interferon beta-1b which is being developed for the treatment of relapsing remitting multiple sclerosis. The objectives of the Phase IA trial were to assess safety and tolerability profile in addition to defining its pharmacological properties.

11 Jan 2011

Positive results from Allovectin-7 Phase 3 trial in patients with metastatic melanoma

Vical Incorporated today announced a new publication summarizing results from the company's completed trials of Allovectin-7 including systemic responses and an excellent safety profile in patients with metastatic melanoma.

11 Jan 2011

Study supports use of telomerase inhibitors for treatment of childhood cancers

Geron Corporation today announced the publication of preclinical data demonstrating that the company's telomerase inhibitor drug, imetelstat (GRN163L), currently in Phase 2 clinical trials, selectively targets cancer stem cells in pediatric tumors of neural origin.

11 Jan 2011

Cautionary note on measuring perceived pain in research

It is well known that pain is a highly subjective experience. We each have a pain threshold, but this can vary depending on distractions and mood. A paper in the International Journal of Behavioural and Healthcare Research offers a cautionary note on measuring perceived pain in research.

11 Jan 2011

TransPharma reports positive results from ViaDerm-Calcitonin Phase 1 trial for musculoskeletal disorders

TransPharma Medical Ltd., a specialty pharmaceutical company focused on the development and commercialization of drug products utilizing a proprietary active transdermal drug delivery technology, announced today successful results of a Phase I clinical trial of its self-applied ViaDerm-Calcitonin product for the treatment of musculoskeletal disorders such as osteoarthritis and musculoskeletal pain.

11 Jan 2011

Clinical Trial News and Research

FDA Advisory Committee recommends non-approval of liprotamase for exocrine pancreatic insufficiency

GSK, ChemoCentryx initiate '786 Phase III clinical trial for Crohn's disease

FDA panel rejects new pancreatic enzyme replacement drug

Endosense initiates enrollment in TactiCath Contact Force Ablation Catheter Study for Atrial Fibrillation

Study shows delivering cancer drug in hydrophobic nanoparticle is a safe and effective prostate cancer therapy

UVA Cancer Center moves to OnCore Clinical Research Management System

Scientists find way to prevent early stage pancreatic cancer in research models

Epigenetic therapy holds promise for cancer management

UH, Case Western University commence clinical trial for bipolar disorder

Neurology professor receives MFRF's 'See the Light' award for Tay-Sachs research

Apixaban drug raises hope for DVT prevention in patients undergoing hip replacement surgery

Herpes zoster vaccine reduces risk of developing shingles by 55%

SCRI to lead clinical development of AstraZeneca's novel targeted oncology compound

FemmePharma completes FP 1097 Phase II clinical trial in women with OAB

SciClone initiates phase 2b study of SCV-O7 for oral mucositis

ALLOZYNE completes AZ01 Phase IA clinical trial in relapsing remitting multiple sclerosis

Positive results from Allovectin-7 Phase 3 trial in patients with metastatic melanoma

Study supports use of telomerase inhibitors for treatment of childhood cancers

Cautionary note on measuring perceived pain in research

TransPharma reports positive results from ViaDerm-Calcitonin Phase 1 trial for musculoskeletal disorders

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