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BD Diagnostics receives 510(k) clearance to market GBS assay on BD MAX System

BD Diagnostics, a segment of BD, announced today that it has received 510(k) clearance from the U.S. Food and Drug Administration to market the BD MAX™ GBS Assay for Group B Streptococcus on the BD MAX System. The BD MAX System is a next-generation automated workstation for molecular testing designed to streamline workflow and offer full walkaway automation to accommodate varying workloads for maximum lab efficiency and flexibility.

From BD (Becton, Dickinson and Company) 3 Jun 2010

Data on ImmunoCellular Therapeutics' ICT-107 for GBM to be presented at 46th ASCO

ImmunoCellular Therapeutics, Ltd. a biotechnology company focused on the development of novel immune-based cancer therapies, today announced that data from a recent clinical trial of ICT-107, the company's dendritic cell based cancer vaccine candidate for the treatment of glioblastoma multiforme (GBM), will be presented at the 46th Annual Meeting of the American Society of Clinical Oncology (ASCO) being held June 4-8 in Chicago.

2 Jun 2010

Axcan extends use of Medidata Rave as EDC and CDM system

Medidata Solutions, a leading global provider of SaaS-based clinical development solutions, today announced that Axcan Pharma Inc. has extended its use of Medidata Rave as its electronic data capture and clinical data management system, bringing study build and execution into the organization through Medidata training and mentoring.

2 Jun 2010

SAGES issues new practice guideline for surgical treatment of GERD

BARRX Medical Inc., a leader in the development of minimally invasive medical devices designed to remove precancerous tissue from within the gastrointestinal tract, reported today that the Society of American Gastrointestinal and Endoscopic Surgeons has issued a new practice guideline for the surgical treatment of gastroesophageal reflux disease. Left untreated, reflux of stomach contents such as acid and bile into the esophagus in GERD patients often leads to injury and chronic inflammation of the lining of the esophagus.

2 Jun 2010

Raptor Pharmaceutical acquires exclusive license to intellectual property for Huntington's Disease treatment

Raptor Pharmaceutical Corp., announced that the Company has acquired an exclusive worldwide license to intellectual property related to the potential treatment of Huntington's Disease from the Weizmann Institute of Science in Israel and Niigata University in Japan. In addition, Raptor has added Professor Lawrence Steinman, M.D., an inventor on the Weizmann patent, to its Advisory Board.

2 Jun 2010

Genes influence AIAA side effect in breast cancer survivors

Aromatase inhibitor-associated arthralgia (AIAA) is a major side effect in breast cancer survivors, producing joint pain so severe that as many as ten percent of women discontinue their therapy prematurely while undergoing treatment with these lifesaving drugs.

2 Jun 2010

ZymoGenetics commences Phase 2B study of PEG-Interferon lambda in hepatitis C

ZymoGenetics, Inc. today announced the initiation of the second part of a Phase 2 clinical trial with PEG-Interferon lambda (IL-29) and ribavirin in treatment-naïve patients with chronic hepatitis C virus (HCV) infection. ZymoGenetics is developing the investigational compound PEG-Interferon lambda in collaboration with Bristol-Myers Squibb Company.

2 Jun 2010

GMC to participate in ProTECT III study of progesterone for emergency treatment of TBI

Geisinger Medical Center will participate in ProTECT III, a groundbreaking National Institute of Health -sponsored research study for the emergency treatment of traumatic brain injuries using the hormone progesterone.

2 Jun 2010

Shionogi Pharma presents study results of PSD502 for treatment of primary PE at AUA 2010

Shionogi Pharma, Inc., a U.S.-based group company of Shionogi & Co., Ltd., today presented data summarizing the results of two pivotal studies of the investigational new drug PSD502, a topical metered dose spray being developed for the treatment of primary premature ejaculation. These data were presented at the 2010 American Urological Association Annual Meeting in San Francisco.

2 Jun 2010

Emerson Ecologics announces awardees of Partner status in Emerson Quality Program

Emerson Ecologics, LLC announces the debut of the first group of manufacturers to be awarded Partner status in the Emerson Quality Program(SM) (EQP). This one-of-a-kind quality assurance program for the nutritional supplements industry provides practitioners with manufacturer-specific quality and safety information to assist in confidently recommending the best products to patients.

2 Jun 2010

UT Southwestern researchers compare TVT and TOT sling procedures for stress urinary incontinence

As part of a national clinical trial, UT Southwestern Medical Center researchers found little difference in effectiveness between two popular treatments for one of the most common ailments among American women: stress urinary incontinence.

2 Jun 2010

Texas Heart Institute at St. Luke's Episcopal Hospital performs 1000th carotid artery stent procedure

The Texas Heart Institute (THI) at St. Luke's Episcopal Hospital has announced another major milestone in improved patient care, after performing its 1000th carotid artery stent procedure. Carotid artery stenting (CAS) has emerged as a less invasive treatment for stroke-causing blockages in the carotid artery, meaning patients generally have fewer risks for complications, shorter hospital stays and recovery times and less expense.

2 Jun 2010

Santarus commences enrollment in rifamycin SV MMX Phase III clinical program for travelers' diarrhea

Santarus, Inc., a specialty biopharmaceutical company, today announced that is has begun to enroll patients in the first study in its Phase III clinical program to evaluate the efficacy and safety of rifamycin SV MMX® for the treatment of patients with travelers' diarrhea.

2 Jun 2010

Curemark commences clinical trial enrollment for CM-AT autism treatment at two more sites

Curemark, LLC,, a drug research and development company focused on the treatment of neurological diseases, announced that the company has opened clinical trial enrollment for CM-AT, its autism treatment, at the University of Pittsburgh and the Alexian Brothers Behavioral Health Hospital in Hoffman Estates, Illinois, near Chicago. A total of 12 sites nationwide are recruiting patients for CM-AT Phase III clinical trials.

2 Jun 2010

Azithromycin as effective as penicillin for early-stage syphilis: Study

In a clinical trial involving HIV-negative volunteers with early-stage syphilis, researchers have found that antibiotic pills (azithromycin) are as effective as penicillin injections in curing early-stage syphilis. The study was supported by the National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health.

2 Jun 2010

Phase 3 pivotal REVIVE study data of VIVUS' avanafil for ED presented at 2010 AUA

VIVUS, Inc. today announced that data from the previously reported phase 3 pivotal REVIVE (TA-301) study, evaluating the safety and efficacy of the investigational drug avanafil for the treatment of erectile dysfunction (ED), were presented at the American Urological Association (AUA) 2010 Annual Meeting.

2 Jun 2010

US Oncology introduces new KnowMed Technology Platform to support oncologists nationwide

US Oncology, Inc., the nation's leading integrated oncology company, today announced its new iKnowMed™ Technology Platform to support community oncologists nationwide. This new platform enhances cancer care quality and practice efficiency through integrated, oncology-specific technologies that enable community oncologists to solve challenges in the areas of care delivery, drug management, and revenue cycle management.

2 Jun 2010

TapImmune signs Licensing Option agreement with Mayo Clinic for breast cancer vaccine technology

TapImmune Inc. announced that it has signed an exclusive Licensing Option agreement with Mayo Clinic, Rochester, MN, for clinical development of a breast cancer vaccine technology. The option to license this technology can be exercised after Phase I clinical trials under terms agreed between Mayo Clinic and TapImmune.

2 Jun 2010

McGill University granted 'Orphan Drug Designation' for pulmonary infection drug fenretinide

In addition to their suffering, rare disease patients often have to face the harsh reality that few pharmaceutical companies will ever be able to offer new treatments for their condition because the costs of new treatments will never be recovered from such a small market. But there are ways they can be helped. The U.S. Food and Drug Administration's "Orphan Drug Designation" offers a wide range of benefits that help organizations developing treatments for diseases and conditions affecting fewer than 200,000 patients in the United States.

2 Jun 2010

Enrollment and dosing in NeuroDerm's Phase I clinical trial of ND0611 completed

NeuroDerm, Ltd. announced today the successful enrollment and dosing in its Phase I clinical trial of ND0611. ND0611, a proprietary drug formula administered via a dermal patch, is designed to maintain continuous therapeutic levodopa concentrations for improving the treatment of Parkinson's disease.

1 Jun 2010

Clinical Trial News and Research

BD Diagnostics receives 510(k) clearance to market GBS assay on BD MAX System

Data on ImmunoCellular Therapeutics' ICT-107 for GBM to be presented at 46th ASCO

Axcan extends use of Medidata Rave as EDC and CDM system

SAGES issues new practice guideline for surgical treatment of GERD

Raptor Pharmaceutical acquires exclusive license to intellectual property for Huntington's Disease treatment

Genes influence AIAA side effect in breast cancer survivors

ZymoGenetics commences Phase 2B study of PEG-Interferon lambda in hepatitis C

GMC to participate in ProTECT III study of progesterone for emergency treatment of TBI

Shionogi Pharma presents study results of PSD502 for treatment of primary PE at AUA 2010

Emerson Ecologics announces awardees of Partner status in Emerson Quality Program

UT Southwestern researchers compare TVT and TOT sling procedures for stress urinary incontinence

Texas Heart Institute at St. Luke's Episcopal Hospital performs 1000th carotid artery stent procedure

Santarus commences enrollment in rifamycin SV MMX Phase III clinical program for travelers' diarrhea

Curemark commences clinical trial enrollment for CM-AT autism treatment at two more sites

Azithromycin as effective as penicillin for early-stage syphilis: Study

Phase 3 pivotal REVIVE study data of VIVUS' avanafil for ED presented at 2010 AUA

US Oncology introduces new KnowMed Technology Platform to support oncologists nationwide

TapImmune signs Licensing Option agreement with Mayo Clinic for breast cancer vaccine technology

McGill University granted 'Orphan Drug Designation' for pulmonary infection drug fenretinide

Enrollment and dosing in NeuroDerm's Phase I clinical trial of ND0611 completed

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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