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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

Abraxis BioScience's Phase 3 trial comparing ABRAXANE with Taxol injection meets primary endpoint

Abraxis BioScience, Inc. today announced that its randomized registrational Phase 3 clinical trial comparing ABRAXANE® (protein-bound paclitaxel) with Taxol® (paclitaxel) injection, both in combination with carboplatin, met the study’s primary endpoint by demonstrating that ABRAXANE showed a significant improvement in overall response rate as compared to Taxol, in the first-line treatment of patients with advanced non-small cell lung cancer (NSCLC), as assessed by independent radiologist review.

17 Mar 2010

SBRT may improve survival rates for lung-cancer patients: Study

A radiation therapy that uses multiple radiation beams to target tumors precisely has been shown to eliminate the primary tumor and ultimately may improve survival rates for lung-cancer patients unable to undergo surgery, according to UT Southwestern Medical Center physicians who led a national clinical trial of the treatment.

17 Mar 2010

Protalix BioTherapeutics commences clinical trial of human acetylcholinesterase for biodefense indications

Protalix BioTherapeutics, Inc. announced today that it has initiated a phase I clinical trial of PRX-105, the Company's plant cell expressed pegylated recombinant human acetylcholinesterase product candidate in development for biodefense indications. The trial is designed to study the safety of PRX-105 by administering a bolus intravenous injection of PRX-105 in healthy volunteers.

17 Mar 2010

TRITON-TIMI 38 study evaluates response rates in patients with common genetic variant in ABCB1 gene

A new analysis of the TRITON-TIMI 38 study evaluated response rates in patients with a common genetic variant in the ABCB1 gene. Patients enrolled in the TRITON-TIMI 38 study were treated with dual antiplatelet therapy with either Plavix® (clopidogrel) plus aspirin or Effient® (prasugrel) plus aspirin and managed with percutaneous coronary intervention (PCI) following an acute coronary syndrome (ACS) event.

17 Mar 2010

AstraZeneca Canada's IRESSA receives approval for treatment of NSCLC

AstraZeneca Canada announces the recently approved indication for IRESSA(R), a once-daily oral targeted therapy for the first-line treatment of patients with locally advanced (not amenable to curative therapy) or metastatic non-small cell lung cancer (NSCLC) who have activating mutations of the epidermal growth factor receptor-tyrosine kinase (EGFR-TK). In conjunction with this approval, AstraZeneca is also announcing the availability of a diagnostic test which can now determine a patient's EGFR mutation status, representing a new era in personalized lung cancer treatment in Canada.

17 Mar 2010

Avid Bioservices highlights data of single-use bioreactors and traditional stainless steel bioreactors

Avid Bioservices, Inc. today presented data highlighting the comparability of production run performance between the company's single-use bioreactors (Thermo Scientific HyClone S.U.B.) and its traditional stainless steel bioreactors at the Thermo Scientific BioProduction Optimization Workshop in San Francisco, California.

From Thermo Fisher Scientific Inc. 17 Mar 2010

Neovasc Reducer three-year follow-up data presented at 2010 ACC annual meeting

Neovasc Inc., a developer of novel technologies used to treat vascular disease, today presented results from the follow-up phase of the initial clinical trial of its Neovasc Reducer(TM) product at the American College of Cardiology 2010 annual meeting. The Neovasc Reducer is a novel implantable product designed to treat heart disease patients who suffer from refractory angina. The new data shows that three years after implantation of the Reducer, the majority of patients continued to show measurable improvement in angina symptoms.

17 Mar 2010

Vertex Pharmaceuticals' telaprevir and VX-222 HCV inhibitor abstracts accepted for presentation at 45th EASL meeting

Vertex Pharmaceuticals Incorporated today announced that multiple abstracts related to the hepatitis C virus (HCV) protease inhibitor telaprevir and the HCV polymerase inhibitor VX-222 were accepted for presentation at the 45th Annual Meeting of the European Association for the Study of the Liver (EASL) in Vienna, Austria, April 14-18, 2010.

17 Mar 2010

Clinical Trial News and Research

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

Abraxis BioScience's Phase 3 trial comparing ABRAXANE with Taxol injection meets primary endpoint

SBRT may improve survival rates for lung-cancer patients: Study

Protalix BioTherapeutics commences clinical trial of human acetylcholinesterase for biodefense indications

TRITON-TIMI 38 study evaluates response rates in patients with common genetic variant in ABCB1 gene

AstraZeneca Canada's IRESSA receives approval for treatment of NSCLC

Avid Bioservices highlights data of single-use bioreactors and traditional stainless steel bioreactors

Neovasc Reducer three-year follow-up data presented at 2010 ACC annual meeting

Vertex Pharmaceuticals' telaprevir and VX-222 HCV inhibitor abstracts accepted for presentation at 45th EASL meeting

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