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Phase III trial results of lixisenatide for type 2 diabetes presented at 46th EASD

Sanofi-aventis announced today the first Phase III results of the GetGoal clinical trial program assessing the efficacy and safety of lixisenatide, a once-daily GLP-1 receptor agonist, as monotherapy in patients with type 2 diabetes. These results were presented at the European Association for the Study of Diabetes (EASD) 46th Annual Meeting in Stockholm, Sweden.

20 Sep 2010

$ONS trial results show promise for treating medically refractory chronic migraines: ONSTIM study$

ONS trial results show promise for treating medically refractory chronic migraines: ONSTIM study

Medtronic, Inc. announced that data from a multicenter, prospective, randomized, blinded, feasibility trial published today show promise for occipital nerve stimulation for treating medically refractory chronic migraines and support the need for further controlled study of the treatment. The study, called Occipital Nerve Stimulation for the Treatment of Intractable Migraine, included severely debilitated patients who had regularly experienced 15 or more headache days per month that were not responsive to currently available medical therapies.

18 Sep 2010

Pazopanib drug reduces thyroid cancer progression: Study

The drug pazopanib may help revolutionize the care of patients with metastatic, rapidly progressive differentiated thyroid cancers, say researchers at Mayo Clinic who are publishing findings of a phase II clinical trial in The Lancet Oncology.

18 Sep 2010

Researchers suggest potentially valuable role for minocycline plus N-acetylcysteine to treat TBI

Traumatic brain injury is a serious public health problem in the United States. Recent data show that approximately 1.7 million people sustain a traumatic brain injury annually. While the majority of TBIs are concussions or other mild forms, traumatic brain injuries contribute to a substantial number of deaths and cases of permanent disability.

18 Sep 2010

Minocycline plus N-acetylcysteine may help treat TBI

Traumatic brain injury (TBI) is a serious public health problem in the United States. Recent data show that approximately 1.7 million people sustain a traumatic brain injury annually. While the majority of TBIs are concussions or other mild forms, traumatic brain injuries contribute to a substantial number of deaths and cases of permanent disability.

18 Sep 2010

Elixir Medical commences enrollment in EXCELLA BD trial for DESyne BD Novolimus Eluting CSS

Elixir Medical Corporation, a developer of product platforms that combine innovative medical devices with potent pharmaceuticals for site-specific therapies, announced the initiation of patient enrollment in the EXCELLA BD Randomized Clinical Trial designed to evaluate Elixir's next generation Novolimus Eluting Coronary Stent System (CSS) with bioabsorbable coating, the Elixir DESyne BD Novolimus Eluting CSS.

18 Sep 2010

Boehringer Ingelheim commences afatinib Phase III clinical trial in advanced breast cancer

Boehringer Ingelheim today announced the initiation of a phase III clinical trial to investigate one of its most advanced oncology pipeline compounds, afatinib, for the treatment of patients with advanced (metastatic) breast cancer. Afatinib is an oral compound (taken as a tablet), which is a next generation, targeted therapy, that irreversibly inhibits both, the epidermal growth factor receptor (EGFR/HER1) and the human epidermal receptor HER2, which are involved in tumour growth and spread.

18 Sep 2010

Aradigm to present Phase 1 studies of inhaled liposomal ciprofloxacin at 2010 ERS Congress

Aradigm Corporation today announced it is presenting data on September 22, 2010, from its Phase 1 studies at the ERS Annual Congress in Barcelona, Spain. The podium presentation elaborates on the pharmacokinetic parameters of ciprofloxacin in the blood and sputum samples that were observed in the healthy volunteers and non-cystic fibrosis bronchiectasis (BE) patients.

17 Sep 2010

SBi reports continuing growth for S.T.A.R. ankle arthroplasty implant system

Small Bone Innovations, Inc. (SBi), a leading, privately held orthopedics company focused primarily on arthroplasty and trauma reconstruction technology and treatments for the small bones & joints, reported continuing growth for its S.T.A.R. ankle arthroplasty implant system with August being the biggest month ever for the S.T.A.R. in terms of revenues and surgeries.

From Evident Corporation - Life Sciences 17 Sep 2010

Research finds placebo improves sexual satisfaction among women

Many women with low sex drives reported greater sexual satisfaction after taking a placebo, according to new psychology research from The University of Texas at Austin and Baylor College of Medicine.

17 Sep 2010

Vital Therapies expands SILVER clinical trial to Middle East

Vital Therapies, Inc., is pleased to announce that the first subject has been enrolled at National Guard Hospital in Riyadh, Kingdom of Saudi Arabia in the further expansion of its SILVER clinical trial to the Middle East. The trial is evaluating whether VTI's biological cellular therapy product, ELAD, can prevent deterioration of liver function and improve the survival of patients with acute-on-chronic liver failure.

17 Sep 2010

Pharma Lynx licenses NewCardio's QTinno automated cardiac safety solution

NewCardio, Inc., a cardiovascular diagnostic solutions developer, announced today that Pharma Lynx, a global contract research organization and a subsidiary of Diverse Lynx, has signed an MSA to license NewCardio's QTinno™ solution for use in Phase 1 studies. Pharma Lynx has particular expertise in oncology studies, including QTc studies involving both healthy subjects and cancer patients, and QTinno will add to Pharma Lynx's already robust capabilities, enabling it to deliver fully automated QTc studies to its sponsors.

17 Sep 2010

Metabolic Solutions to present MSDC-0160 clinical candidate data at EASD conference

Metabolic Solutions Development Company (MSDC), will present research at the European Association for the Study of Diabetes (EASD) annual conference in Stockholm, Sweden on Sept. 23, 2010. The research indicates that the company's clinical candidate, MSDC-0160, promotes the proliferation of stem cells that create brown fat, leading to the creation of more brown fat. The research was conducted in tissue cultures and mice.

17 Sep 2010

Contracting & Outsourcing 2010 Conference to feature presentations of pharma, biopharma outsourcing

On Sept. 23 and 24, the Hyatt Regency in New Brunswick, N.J. will host Contracting & Outsourcing 2010, the 9th annual Conference and Tabletop Exhibition held by Contract Pharma Magazine. This year's Conference will feature a keynote presentation by Mac Lynch, Vice President, Contract Manufacturing at Pfizer, covering Global Pharma Outsourcing Trends. Other speakers and panelists represent FDA, Johnson & Johnson, Roche/Genentech, Bristol-Myers Squibb, Merck, GlaxoSmithKline and more.

17 Sep 2010

LigoCyte to enroll 98 subjects in first clinical trial for bivalent IM norovirus vaccine

LigoCyte Pharmaceuticals, Inc., a private, clinical-stage biopharmaceuticals company focused on the development of innovative vaccine products, announced today that it has initiated the first clinical trial for its bivalent intramuscular (IM) norovirus vaccine candidate, marking the fourth human clinical trial in the Company's norovirus virus-like particle (VLP) vaccine program.

17 Sep 2010

ImmunoCellular contracts with Averionto to execution ICT-107 cancer-vaccine Phase II study

ImmunoCellular Therapeutics, Ltd., a biotechnology company focused on the development of novel immune-based cancer therapies, today announced that it has contracted with the clinical research organization (CRO) Averion International Corp. to conduct its planned Phase II study of ICT-107, the Company's lead cancer-vaccine candidate for the treatment of glioblastoma multiforme (GBM).

17 Sep 2010

FDA approves expanded indication for Boston Scientific's CRT-Ds

Boston Scientific Corporation today announced that the U.S. Food and Drug Administration (FDA) has approved an expanded indication for its cardiac resynchronization therapy defibrillators (CRT-Ds), including the COGNIS® CRT-D. The exclusive expanded indication is effective immediately and makes Boston Scientific CRT-Ds the only devices approved by the FDA for patients in all New York Heart Association (NYHA) classes of heart failure.

17 Sep 2010

Alcohol addiction drug may help opioid addicts: FDA panel considers reports

A U.S. Food and Drugs Administration (FDA) panel, this Thursday agreed that a new drug Vivitrol helps alcoholics and opioid addicts kick the habit. The panel voted 11 to 2 that there was sufficient evidence from a single clinical trial that Vivitrol is effective when it comes to helping people addicted to painkillers.

17 Sep 2010

Medtronic Deep Brain Stimulation Therapy for severe epilepsy receives CE Mark approval

Medtronic, Inc. today announced that the company has received CE (Conformité Européenne) Mark approval for Medtronic Deep Brain Stimulation (DBS) Therapy in Europe as adjunctive treatment for partial-onset seizures in adults with medically refractory epilepsy. DBS therapy for epilepsy delivers controlled electrical pulses to a target in the brain called the anterior nucleus of the thalamus, which is part of a circuit involved in seizures.

17 Sep 2010

FDA grants AGTC $1M for Phase II human clinical trial in alpha-1 antitrypsin deficiency

Applied Genetic Technologies Corporation, a privately-held, clinical stage biotechnology company developing novel systems to deliver human therapeutics, announces that it has received a grant of $1 million from the Food and Drug Administration (FDA Orphan Drugs Program) to fund a Phase II Human Clinical Trial evaluating the safety and efficacy of a treatment for Alpha 1 Antitrypsin Deficiency (AAT), a genetic disease known to result in serious lung and/or liver disease.

17 Sep 2010

Clinical Trial News and Research

Phase III trial results of lixisenatide for type 2 diabetes presented at 46th EASD

ONS trial results show promise for treating medically refractory chronic migraines: ONSTIM study

Pazopanib drug reduces thyroid cancer progression: Study

Researchers suggest potentially valuable role for minocycline plus N-acetylcysteine to treat TBI

Minocycline plus N-acetylcysteine may help treat TBI

Elixir Medical commences enrollment in EXCELLA BD trial for DESyne BD Novolimus Eluting CSS

Boehringer Ingelheim commences afatinib Phase III clinical trial in advanced breast cancer

Aradigm to present Phase 1 studies of inhaled liposomal ciprofloxacin at 2010 ERS Congress

SBi reports continuing growth for S.T.A.R. ankle arthroplasty implant system

Research finds placebo improves sexual satisfaction among women

Vital Therapies expands SILVER clinical trial to Middle East

Pharma Lynx licenses NewCardio's QTinno automated cardiac safety solution

Metabolic Solutions to present MSDC-0160 clinical candidate data at EASD conference

Contracting & Outsourcing 2010 Conference to feature presentations of pharma, biopharma outsourcing

LigoCyte to enroll 98 subjects in first clinical trial for bivalent IM norovirus vaccine

ImmunoCellular contracts with Averionto to execution ICT-107 cancer-vaccine Phase II study

FDA approves expanded indication for Boston Scientific's CRT-Ds

Alcohol addiction drug may help opioid addicts: FDA panel considers reports

Medtronic Deep Brain Stimulation Therapy for severe epilepsy receives CE Mark approval

FDA grants AGTC $1M for Phase II human clinical trial in alpha-1 antitrypsin deficiency

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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