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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

TSO3 reports net loss of $9.2M for fiscal 2009

TSO3 Inc. an innovator in sterilization technology for medical devices in healthcare settings using ozone, posted sales totalling $1.3 million for the fiscal year ended December 31, 2009, compared to $2.2 million one year earlier. During the year, the Company sold five of its first generation STERIZONE(R) sterilizers and accessories, whereas it sold 13 in the preceding fiscal year.

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

Agilent Technologies introduces new ion exchange and size exclusion columns for analysis of bio-molecules

Agilent Technologies Inc. today announced the availability of new ion exchange and size exclusion columns specifically designed for the analysis of bio-molecules including monoclonal antibodies, recombinant proteins, peptides, vaccine products and DNA/RNA. The columns provide robust, reproducible and high-resolution solutions for biopharmaceutical manufacturers to effectively monitor the safety, efficacy and stability of their products.

17 Mar 2010

Avedro to acquire Corneal Collagen Crosslinking Phase III study rights from Peschke Meditrade

Avedro, Inc. today announced it has signed a definitive agreement with Swiss-based Peschke Meditrade GmbH to acquire the rights to its Phase III studies of Corneal Collagen Crosslinking for the treatment of progressive keratoconus and post LASIK ectasia. The two randomized, controlled, multi-site clinical trials are designed to assess the safety and efficacy of riboflavin/ultraviolet-A light for halting the progression of these degenerative disorders and the accompanying decline in patient’s visual acuity.

17 Mar 2010

Boston University's Technology Development Office completes exclusive license of Project RED to Engineered Care

Boston University's Technology Development Office, on behalf of Boston Medical Center, Northeastern University, and Massachusetts Institute of Technology (MIT), has completed the exclusive license of Project RED (Re-Engineered Discharge) to Engineered Care, Inc.

17 Mar 2010

MedSolutions launches oncology management program for cancer patients

MedSolutions (www.medsolutions.com), a leading provider of medical cost management services, today announced the launch of its oncology management program, which uses evidence-based guidelines to ensure appropriate use of diagnostic imaging, radiation therapy and drugs for cancer patients.

17 Mar 2010

Glenmark Generics, Konec ordered to stop marketing unapproved nitroglycerin tablets

The U.S. Food and Drug Administration today ordered Glenmark Generics of Mahwah, N.J., and Konec Inc. of Tucson, Ariz., to stop marketing unapproved nitroglycerin tablets. The tablets are placed under the tongue to relieve chest pain or to stop a heart attack and are marketed in 0.3 mg, 0.4 mg, and 0.6 mg dosages.

17 Mar 2010

False Claims Act allegations over marketing of morphine-based drug Kadian: Alpharma to pay $42.5M

American pharmaceutical manufacturer Alpharma Inc. has agreed to pay $42.5 million to resolve False Claims Act allegations in connection with the marketing of the morphine-based drug, Kadian, the Justice Department announced today. The settlement resolves allegations that, between January 1, 2000 and December 29, 2008, Alpharma paid health care providers to induce them to promote or prescribe Kadian, and made misrepresentations about the safety and efficacy of the drug, which is used to treat chronic moderate to severe pain.

17 Mar 2010

Unapproved nitroglycerin tablets: FDA orders Glenmark Generics and Konec to stop marketing

17 Mar 2010

Quinnova Pharmaceuticals introduces NEOSALUS CREAM for chronic inflammatory skin conditions

Quinnova Pharmaceuticals, Inc., a specialty pharmaceutical company that develops and markets novel topical delivery platform-based prescription drugs, announced the launch of its NEOSALUSTM CREAM. NEOSALUS CREAM, the latest addition to Quinnova’s NEOSALUS brand, is a prescription product with anti-inflammatory properties that can be used without age or long-term use restrictions for the treatment of a variety of chronic inflammatory skin conditions like atopic dermatitis, contact dermatitis, and hand eczema.

16 Mar 2010

Tolerx publishes follow-up data from study of otelixizumab therapy for new onset T1DM patients

Tolerx, Inc., today announced the publication in Diabetologia, the journal of the European Association for the Study of Diabetes, of the four-year follow-up clinical data from new onset type 1 diabetes (T1DM) patients (age 12-39) who received a single short course of therapy with otelixizumab (ChAglyCD3).

16 Mar 2010

Patient enrollment in Spinal Restoration' Phase III study of Biostat System now underway

Spinal Restoration, Inc. announced today that patient enrollment in the company’s Phase III study of the Biostat System for the treatment of discogenic chronic low back pain is now underway. The study, which will be conducted at 15 U.S. clinical sites, is one of only a few multi-center, randomized, blinded, placebo-controlled trials of a nonsurgical treatment for discogenic low back pain ever to be conducted.

16 Mar 2010

Iverson Genetic Diagnostics to conduct WARFARIN clinical study

Iverson Genetic Diagnostics, Inc. today announced that they will conduct a WARFARIN clinical study to assess the efficacy of gene-based testing prior to initiating warfarin anticoagulation therapy to reduce the incidence of bleeding and thromboembolic events.

16 Mar 2010

Promedior raises $12M in Series C financing

Promedior, Inc., a clinical stage biotechnology company developing novel therapies to treat inflammatory and fibrotic diseases, today announced that it has raised $12 million in a Series C financing round. Forbion Capital Partners led the round, with participation from existing investors Morgenthaler Ventures, HealthCare Ventures, Polaris Venture Partners, and Easton Capital. The Series C financing brings the total capital raised by Promedior over the past year to $27 million.

16 Mar 2010

MRSA Survivors Network urges CDC to declare MRSA an epidemic

MRSA Survivors Network, the nonprofit organization, along with other advocates, urgently plead with the CDC – (Centers for Disease Control and Prevention), along with the Department of Health and Human Services (DHHS) to finally acknowledge the public health crisis to the public and take action.

16 Mar 2010

PERSEUS clinical program demonstrates positive results of TAXUS Element Paclitaxel-Eluting Stent System

Boston Scientific Corporation today announced 12-month results from its PERSEUS clinical program that demonstrated positive safety and efficacy outcomes in workhorse lesions for the platinum chromium TAXUS® Element™ Paclitaxel-Eluting Stent System compared to the TAXUS® Express2™ Paclitaxel-Eluting Stent System.

16 Mar 2010

Medtronic' Endeavor DES demonstrates safety and efficacy profile for coronary artery disease treatment

The consistency and quality of the long-term clinical results for the Endeavor® drug-eluting stent (DES) from Medtronic, Inc., continue to distinguish it as a treatment for coronary artery disease, according to newly released data.

16 Mar 2010

Stage IV colorectal cancer: Therapy that improves overall survival over IFL/bevacizumab will earn 60% patient share

Decision Resources, one of the world's leading research and advisory firms for pharmaceutical and healthcare issues, finds that a therapy that would improve median overall survival over IFL (bolus 5-fluorouracil, generics/leucovorin, generics/irinotecan*) plus bevacizumab (Roche/Genentech/Chugai's Avastin), would earn a 60 percent patient share in stage IV colorectal cancer, according to surveyed U.S. oncologists. In Europe, such an agent would earn a 50 percent patient share, according to surveyed European oncologists.

16 Mar 2010

Obesity limits body's ability to fight infections

Obesity may limit the body's ability to develop immunity to influenza viruses, particularly secondary infections, by inhibiting the immune system's ability to "remember" how it fought off previous similar bouts of illness, according to new research from the University of North Carolina at Chapel Hill.

16 Mar 2010

Efficacy News and Research

Protalix BioTherapeutics commences clinical trial of human acetylcholinesterase for biodefense indications

TSO3 reports net loss of $9.2M for fiscal 2009

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

Agilent Technologies introduces new ion exchange and size exclusion columns for analysis of bio-molecules

Avedro to acquire Corneal Collagen Crosslinking Phase III study rights from Peschke Meditrade

Boston University's Technology Development Office completes exclusive license of Project RED to Engineered Care

MedSolutions launches oncology management program for cancer patients

Glenmark Generics, Konec ordered to stop marketing unapproved nitroglycerin tablets

False Claims Act allegations over marketing of morphine-based drug Kadian: Alpharma to pay $42.5M

Unapproved nitroglycerin tablets: FDA orders Glenmark Generics and Konec to stop marketing

Quinnova Pharmaceuticals introduces NEOSALUS CREAM for chronic inflammatory skin conditions

Tolerx publishes follow-up data from study of otelixizumab therapy for new onset T1DM patients

Patient enrollment in Spinal Restoration' Phase III study of Biostat System now underway

Iverson Genetic Diagnostics to conduct WARFARIN clinical study

Promedior raises $12M in Series C financing

MRSA Survivors Network urges CDC to declare MRSA an epidemic

PERSEUS clinical program demonstrates positive results of TAXUS Element Paclitaxel-Eluting Stent System

Medtronic' Endeavor DES demonstrates safety and efficacy profile for coronary artery disease treatment

Stage IV colorectal cancer: Therapy that improves overall survival over IFL/bevacizumab will earn 60% patient share

Obesity limits body's ability to fight infections

Bringing real-time analytics to downstream bioprocess monitoring

Designing fluidic architecture for scalable diagnostic platforms

Evaluating new approaches for rare disease genomics

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