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Atritech to initiate confirmatory study of WATCHMAN LAA Closure Device

Atritech, Inc., an emerging medical device company, announced today that it has obtained clarity from the U.S. Food and Drug Agency on the regulatory path towards full approval of its WATCHMAN® Left Atrial Appendage Closure Technology in the United States.

19 Mar 2010

GSK's 2009 Corporate Responsibility Report published online

In its 2009 Corporate Responsibility Report published online today, GSK reiterated its commitment to running its business responsibly and to making the company more responsive, more flexible and more open to the expectations of society.

19 Mar 2010

Cedars-Sinai Medical Center announces clinical trial of minimally invasive procedure for opening carotid arteries

Patients who suffer from plaque-related narrowing of a carotid artery but are not good candidates for open surgery may be eligible to participate in a clinical trial at Cedars-Sinai Medical Center of a minimally invasive procedure designed to open carotid arteries the way angioplasty and stenting clear arteries of the heart.

19 Mar 2010

Three scientists receive 2010 Discoverers Award for developing new class of HIV drug

Three scientists who led the 11-year quest to develop a groundbreaking HIV drug today received the 2010 Discoverers Award -- the highest honor given to scientists by the Pharmaceutical Research and Manufacturers of America. The honorees are Tony Wood, Ph.D., Elna van der Ryst, M.D., Ph.D. and Manos Perros, Ph.D.

19 Mar 2010

FDA approves Somaxon Pharmaceuticals' Silenor for treatment of insomnia

Somaxon Pharmaceuticals, Inc. today announced that the U.S. Food and Drug Administration (FDA) has approved the New Drug Application (NDA) for Silenor® (doxepin) for the treatment of insomnia characterized by difficulty with sleep maintenance.

19 Mar 2010

Cameron Health initiates clinical trial of minimally invasive S-ICD System for patients at risk of SCA

Cameron Health, Inc. today announced the commencement of the company's pivotal clinical trial to gain U.S. approval of its Subcutaneous Implantable Defibrillator (S-ICD®) System. The minimally invasive S-ICD System is prescribed for use in patients at risk of Sudden Cardiac Arrest (SCA). The S-ICD System is unique in that the implantation of the system is entirely subcutaneous; no leads are in or on the heart.

19 Mar 2010

U.S.-based CRO licenses NewCardio's QTinno software solution for automating cardiac safety analysis

NewCardio, Inc., a cardiac diagnostic technology provider, announced today that a U.S.-based CRO that provides early phase and specialty clinical drug development services to the pharmaceutical industry, has signed an MSA, licensing NewCardio's QTinno™ software solution in order to deliver fully automated cardiac safety analysis in early phase QT studies.

18 Mar 2010

Scientific revelations discovered during Retina Implant’s first human clinical trial

Retina Implant, AG, a leading developer of subretinal implants for the visually impaired, today announced scientific revelations discovered during the company’s first human clinical trial. The results achieved in the 11 patients that were involved in the trial exceeded the company’s expectations for their first trial.

18 Mar 2010

Medtronic Arctic Front Cardiac CryoAblation Catheter System: PMA submission for FDA approval complete

Medtronic, Inc. today announced it has completed Pre-Market Approval (PMA) submission in consideration for U.S. Food and Drug Administration (FDA) approval for the Medtronic Arctic Front® Cardiac CryoAblation Catheter System, which is designed for patients with paroxysmal atrial fibrillation (PAF), an irregular quivering of the upper chambers of the heart that starts and stops on its own. Atrial fibrillation (AF) is the most common heart arrhythmia in the United States, with an estimated three million patients suffering from this condition.

18 Mar 2010

Positive preliminary results from MediciNova's Phase Ib clinical trial of MN-221 for COPD

MediciNova, Inc., a biopharmaceutical company that is publicly traded on the Nasdaq Global Market and the Hercules Market of the Osaka Securities Exchange, today reported positive preliminary results from a Phase Ib clinical trial to evaluate the safety and efficacy of MN-221 in patients with stable, moderate to severe chronic obstructive pulmonary disease (COPD). There were no clinically significant safety concerns noted. Preliminary results demonstrated clinically significant improvements in percent change in forced expiratory volume in one second (FEV(1)).

18 Mar 2010

SANTE study: Deep brain stimulation can reduce seizures

A recent study organized by Stanford University researchers found patients with refractory partial and secondarily generalized seizures had a reduction in seizures after deep brain stimulation. This multi-center clinical trial determined that the benefits of stimulation of the anterior nuclei of thalamus for epilepsy (SANTE) persisted and by 2 years there was a 56% reduction in seizure frequency.

18 Mar 2010

Hypnotherapy and probiotics effective for reducing IBS symptoms

Hypnotherapy seems to be very effective for easing the distressing symptoms of irritable bowel syndrome (IBS), and in a goodly proportion of cases, clears up symptoms altogether, reveal experts during a wide ranging discussion of the condition in a Frontline Gastroenterology podcast.

18 Mar 2010

Agendia to participate in groundbreaking clinical trial for breast cancer

Agendia, a world leader in molecular cancer diagnostics, announced today it will participate in the highly anticipated I-SPY 2 TRIAL for breast cancer, set to launch at the first of nearly twenty research sites.

18 Mar 2010

I-SPY 2: The Biomarkers Consortium launches clinical trial for high risk, fast-growing breast cancers

The Biomarkers Consortium, a unique public-private partnership that includes the U.S. Food and Drug Administration (FDA), the National Institutes of Health (NIH), and major pharmaceutical companies, led by the Foundation for the National Institutes of Health (FNIH), today announced the launch of a highly anticipated clinical trial to help screen promising new drugs being developed for women with high risk, fast-growing breast cancers—women for whom an improvement over standard treatment could dramatically change the odds of survival.

18 Mar 2010

Phase 2a clinical trial results of CPEX Pharmaceuticals' Nasulin insulin

CPEX Pharmaceuticals Inc. today reported preliminary results related to its Phase 2a proof-of-concept clinical trial of the Company’s nasal insulin product, Nasulin™. The study was designed to evaluate the efficacy and safety of Nasulin versus placebo over a 6-week treatment period in subjects with Type 2 diabetes who were being treated with basal insulin and oral anti-diabetes agents.

18 Mar 2010

CytoDyn commences full humanization of Cytolin immune therapy for treating HIV/AIDS

CytoDyn, Inc. has begun full humanization of Cytolin®, the Company’s unique immune therapy for treating HIV/AIDS. Although a murine (mouse) version of Cytolin® was used for previous human experience that included some 200 patients successfully treated for up to two years, as well as an encouraging Phase I(b)/II(a) study, the Company believes that a fully-humanized version is necessary for the clinical trial that is expected to follow the current one (described at http://clinicaltrials.gov) for the reasons explained below.

17 Mar 2010

ONGLYZA-metformin combination: FDA accepts NDA for review

Bristol-Myers Squibb Company and AstraZeneca today announced that the U.S. Food and Drug Administration (FDA) has accepted for review a New Drug Application (NDA) for an investigational fixed dose combination of ONGLYZA™ (saxagliptin), a dipeptidyl peptidase-4 (DPP4) inhibitor, and metformin HCl extended-release tablets as a once-daily treatment for type 2 diabetes mellitus in adults.

17 Mar 2010

Zogenix announces the initiation of pivotal Phase 3 clinical trial with ZX002

Zogenix, Inc., a privately held pharmaceutical company, announced that it has initiated a pivotal Phase 3 clinical trial with ZX002, a novel, oral, controlled-release formulation of hydrocodone without acetaminophen. ZX002 is being developed for the treatment of moderate to severe pain in individuals who require around-the-clock opioid therapy for the control of pain.

17 Mar 2010

Acucela, Otsuka Pharmaceutical granted FDA Fast Track designation for ACU-4429 in treatment of dry AMD

Acucela Inc., a clinical-stage biotechnology company focused on developing new treatments for blinding eye diseases, and Otsuka Pharmaceutical Co., Ltd., today announced that they have received Fast Track designation from the U.S. Food and Drug Administration (FDA) for ACU-4429, an investigational oral treatment for dry age-related macular degeneration (dry AMD).

17 Mar 2010

CDISC approves Nextrials as one of 15 registered solutions providers

Nextrials, Inc., a leader in clinical research software and services, has been approved by the Clinical Data Interchange Standards Consortium as one of 15 registered solutions providers, and is the only company offering an electronic data capture (EDC) product supporting the CDISC Healthcare Link Initiative.

17 Mar 2010

Clinical Trial News and Research

Atritech to initiate confirmatory study of WATCHMAN LAA Closure Device

GSK's 2009 Corporate Responsibility Report published online

Cedars-Sinai Medical Center announces clinical trial of minimally invasive procedure for opening carotid arteries

Three scientists receive 2010 Discoverers Award for developing new class of HIV drug

FDA approves Somaxon Pharmaceuticals' Silenor for treatment of insomnia

Cameron Health initiates clinical trial of minimally invasive S-ICD System for patients at risk of SCA

U.S.-based CRO licenses NewCardio's QTinno software solution for automating cardiac safety analysis

Scientific revelations discovered during Retina Implant’s first human clinical trial

Medtronic Arctic Front Cardiac CryoAblation Catheter System: PMA submission for FDA approval complete

Positive preliminary results from MediciNova's Phase Ib clinical trial of MN-221 for COPD

SANTE study: Deep brain stimulation can reduce seizures

Hypnotherapy and probiotics effective for reducing IBS symptoms

Agendia to participate in groundbreaking clinical trial for breast cancer

I-SPY 2: The Biomarkers Consortium launches clinical trial for high risk, fast-growing breast cancers

Phase 2a clinical trial results of CPEX Pharmaceuticals' Nasulin insulin

CytoDyn commences full humanization of Cytolin immune therapy for treating HIV/AIDS

ONGLYZA-metformin combination: FDA accepts NDA for review

Zogenix announces the initiation of pivotal Phase 3 clinical trial with ZX002

Acucela, Otsuka Pharmaceutical granted FDA Fast Track designation for ACU-4429 in treatment of dry AMD

CDISC approves Nextrials as one of 15 registered solutions providers

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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