Clinical Trial News and Research

RSS

ACRO releases statement regarding proposed privacy rule from HHS

The Association of Clinical Research Organization is pleased that the proposed privacy rule from Department of Health and Human Services strikes an appropriate balance between the critical needs of researchers for access to health information and the desire to protect the privacy of individual's health records.

14 Jul 2010

Supernus initiates SPN812 Phase IIa clinical trial for ADHD in adults

Supernus Pharmaceuticals, Inc. today announced the initiation of a Phase IIa U.S. clinical trial of its product candidate SPN812 for the treatment of ADHD in adults. The trial is a proof-of-concept, randomized, double-blind, placebo-controlled study in healthy adults aged 18 to 64, inclusive, with ADHD. Supernus expects to enroll 50 subjects in the study at 5 sites across the United States.

14 Jul 2010

Fredericksburg Oncology invites participants for new metastatic melanoma clinical trial

Fredericksburg Oncology is now accepting patients for a new clinical trial supported by the National Cancer Institute (NCI) to evaluate treatment for metastatic (advanced stage) melanoma. The current trial, designed at the Mayo Clinic, combines chemotherapy with targeted molecular agents in an effort to improve control of this difficult disease, reports Dr. Frederick C. Tucker, Jr., who heads this practice.

13 Jul 2010

Hi-Tech Pharmacal fourth-quarter net sales increase 6% to $40.5 million

Hi-Tech Pharmacal Co., Inc. today reported results for the fourth quarter and year ended April 30, 2010.

13 Jul 2010

MAP Pharmaceuticals reports results from LEVADEX PK and safety clinical trial in smokers, non-smokers

MAP Pharmaceuticals, Inc. today announced results from a clinical trial comparing the pharmacokinetics (PK) and safety of LEVADEX™ orally inhaled migraine therapy with intravenous dihydroergotamine mesylate (DHE) in smokers and non-smokers. The trial was designed to measure whether systemic absorption and exposure in smokers is greater than in non-smokers. In the trial, the systemic absorption of LEVADEX was not higher and systemic exposure to DHE was not greater in smokers than in non-smokers.

13 Jul 2010

Innocoll submits SPA for phase 3 clinical trial of Cogenzia for adjuvant treatment of infected diabetic foot ulcers

Innocoll, Inc. announced that its wholly-owned subsidiary, Innocoll Technologies Ltd., has submitted a Special Protocol Assessment (SPA) for a proposed phase 3 clinical trial to support the U.S. approval of Cogenzia™: Innocoll's topical antibiotic therapy for the adjuvant treatment of infected diabetic foot ulcers.

13 Jul 2010

Clinical trial initiated to evaluate LibiGel on cognitive function in menopausal women

BioSante Pharmaceuticals, Inc. today announced the initiation of a LibiGel (testosterone gel) clinical trial to evaluate its effect on cognitive function in menopausal women. The trial is a randomized, 6-month comparison of the effect of LibiGel compared to placebo treatment on a variety of learning and memory tasks. The study is being conducted by Dr. Susan Davis, Professor of Women's Health, Department of Medicine, Monash University Women's Health Program in Australia.

13 Jul 2010

SPET-085 is effective in blocking critical enzyme that leads to BPH: Study

A new study, published in the July issue of Advances in Therapy, revealed that a novel saw palmetto extract, SPET-085, is as effective as finasteride, the standard prescription drug therapy, in blocking the critical enzyme that leads to benign prostatic hyperplasia.

13 Jul 2010

Bio-Optronics, CRA partner to enhance clinical trial sites' patient recruitment capabilities

Bio-Optronics and Clinical Research Associates (CRA) have developed a strategic relationship to provide a turn-key solution for a clinical research site's patient recruitment needs, which couples Bio-Optronics' Clinical Conductor™ Clinical Trial Management System (CTMS) and Clinical Research Associates' patient recruitment offerings.

12 Jul 2010

MiCK assay effective in predicting best chemotherapy response for Endometrial Cancer patients: Study

Oncologists working with DiaTech Oncology have published the results of a comprehensive study to determine the effectiveness of the Microculture Kinetic (MiCK) assay for apoptosis in predicting the best chemotherapy response for Endometrial Cancer patients. (Journal of Gynecologic Oncology March 2010 Mar)

12 Jul 2010

Experimental anti-obesity and diabetes drug avoids risk of psychiatric side effects: Study

A second-generation experimental anti-obesity and diabetes drug has shown promise in reducing body weight in rodents just as effectively as the predecessor rimonabant while avoiding the risk of psychiatric side effects that led to the withdrawal of rimonabant from the market and stopped further development of other brain-penetrating drugs of its type.

12 Jul 2010

AngioDynamics adds low-profile, mini models to Smart Port CT family of power-injectable ports

AngioDynamics announced today the global expansion of its Smart Port CT family of power-injectable ports, featuring its patented Vortex® port technology - to include low-profile and mini models for repeated treatments such as chemotherapy and for use with computed tomography (CT).

12 Jul 2010

FDA accepts Protalix's taliglucerase alfa NDA, assigns PDUFA action date

Protalix BioTherapeutics, Inc., announced today that the Company's New Drug Application (NDA) for taliglucerase alfa has been accepted for review by the U.S. Food and Drug Administration (FDA). The FDA granted taliglucerase alfa a standard review time of ten months, assigning a Prescription Drug User Fee Act (PDUFA) action date of February 25, 2011.

12 Jul 2010

Alzheimer's Association launches Internet and phone-based clinical trial matching service

The Alzheimer's Association announced today the launch of Alzheimer's Association TrialMatch(TM), a confidential and free interactive tool that provides comprehensive clinical trial information and an individualized trial matching service for people with Alzheimer's disease and related dementias. The Internet (www.alz.org/trialmatch) and phone-based (800-272-3900) service debuted during the Alzheimer's Association International Conference on Alzheimer's Disease 2010 (AAICAD 2010) in Honolulu, HI.

12 Jul 2010

Interim progress from Phase III TeloVac study of GV1001 vaccine announced

KAEL-GemVax, a leading oncology vaccine company, today announced, through its subsidiary GemVax A.S, encouraging interim progress from the UK-based Phase III TeloVac study of its anti-telomerase therapeutic cancer vaccine GV1001 in pancreatic cancer. The company also strongly believes GV1001 has major "blockbuster" potential as a universal therapeutic cancer vaccine and is developing a strong pipeline for other indications, including lung and liver cancer and melanoma.

12 Jul 2010

Report shows experimental trials have higher risk for bias

A Johns Hopkins review of nearly 150 randomized controlled trials on children - all published in well-regarded medical journals - reveals that 40 to 60 percent of the studies either failed to take steps to minimize risk for bias or to at least properly describe those measures.

12 Jul 2010

bitop's Ectoin allergy nasal spray reduces symptoms of acute allergic rhinitis in two-week crossover study

bitop AG, a biotech company specializing in the development of Ectoin®-containing medical devices, reports that Ectoin allergy nasal spray has been shown to significantly reduce symptoms of acute allergic rhinitis in a two-week observational, randomized, comparative crossover study with 50 patients suffering from acute allergic rhinitis. Based on this study, bitop performed a clinical trial on eyes drops and nasal spray in humans using an environmental exposure chamber (EEC) model.

12 Jul 2010

Biogen Idec, Swedish Orphan Biovitrum announce advancement of rFVIIIFc into registrational study

Biogen Idec and Swedish Orphan Biovitrum today announced that they plan to advance the companies' long-lasting, fully-recombinant factor VIII Fc fusion protein (rFVIIIFc) into a registrational clinical trial in people with hemophilia A. The decision to advance the program is based on promising data from a Phase 1/2a open-label, cross-over, multi-center, dose-escalation study that evaluated the safety and pharmacokinetics of an intravenous injection of rFVIIIFc in 16 previously-treated patients with severe hemophilia A.

12 Jul 2010

Mesoblast schedules formal meeting with FDA to discuss proposed Phase 3 clinical trial program

Australian regenerative medicine company, Mesoblast Limited, today announced that based on positive results from its bone marrow transplant clinical trial conducted at the University of Texas MD Anderson Cancer Center, a formal meeting has been scheduled with the United States Food and Drug Administration to discuss a proposed Phase 3 clinical trial program.

12 Jul 2010

Simple, routine test for detecting subtle onset of diabetes and prediabetes

Having discovered a dramatic increase of an easy-to-detect enzyme in the red blood cells of people with diabetes and prediabetes, Johns Hopkins scientists say the discovery could lead to a simple, routine test for detecting the subtle onset of the disease, before symptoms or complications occur and in time to reverse its course.

9 Jul 2010

Clinical Trial News and Research

ACRO releases statement regarding proposed privacy rule from HHS

Supernus initiates SPN812 Phase IIa clinical trial for ADHD in adults

Fredericksburg Oncology invites participants for new metastatic melanoma clinical trial

Hi-Tech Pharmacal fourth-quarter net sales increase 6% to $40.5 million

MAP Pharmaceuticals reports results from LEVADEX PK and safety clinical trial in smokers, non-smokers

Innocoll submits SPA for phase 3 clinical trial of Cogenzia for adjuvant treatment of infected diabetic foot ulcers

Clinical trial initiated to evaluate LibiGel on cognitive function in menopausal women

SPET-085 is effective in blocking critical enzyme that leads to BPH: Study

Bio-Optronics, CRA partner to enhance clinical trial sites' patient recruitment capabilities

MiCK assay effective in predicting best chemotherapy response for Endometrial Cancer patients: Study

Experimental anti-obesity and diabetes drug avoids risk of psychiatric side effects: Study

AngioDynamics adds low-profile, mini models to Smart Port CT family of power-injectable ports

FDA accepts Protalix's taliglucerase alfa NDA, assigns PDUFA action date

Alzheimer's Association launches Internet and phone-based clinical trial matching service

Interim progress from Phase III TeloVac study of GV1001 vaccine announced

Report shows experimental trials have higher risk for bias

bitop's Ectoin allergy nasal spray reduces symptoms of acute allergic rhinitis in two-week crossover study

Biogen Idec, Swedish Orphan Biovitrum announce advancement of rFVIIIFc into registrational study

Mesoblast schedules formal meeting with FDA to discuss proposed Phase 3 clinical trial program

Simple, routine test for detecting subtle onset of diabetes and prediabetes

Expanding research and clinical options for children with cancer

Examining how pain could play a direct protective role in the gut

From Puberty to Menopause: Clue’s CEO, Audrey Tsang on the Power of Femtech

Latest Life Science News