DIA Biosimilars 2013

United States

NeuroSigma set to commence phase III trial

Tuesday, July 30, 2013 11:33 AM

NeuroSigma, a Los Angeles-based medical device company, has announced conditional approval by the FDA of its IDE application to commence a phase III trial of the Monarch eTNS System for treatment of drug resistant epilepsy. The company is planning to conduct a multi-center trial at medical institutions in the U.S., Europe and Canada.  The objective of the study is to evaluate the safety and effectiveness of the device and provide the basis for a Pre-Market Approval (PMA) application to the FDA.

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Cenduit: Now with Patient Reminders

CRF Health enhances its eCOA solutions

Tuesday, July 30, 2013 09:30 AM

CRF Health, an electronic Clinical Outcome Assessment (eCOA) solutions provider based in Plymouth Meeting, Penn., has announced several innovative enhancements to its TrialMax eCOA solutions. 

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CRF Health – eCOA Forum

PhRMA endorses FDA Safety Over Sequestration Act

Monday, July 29, 2013 11:28 AM

The Pharmaceutical Research and Manufacturers of America (PhRMA) has endorsed the FDA Safety Over Sequestration Act of 2013. PhRMA represents U.S. biopharmaceutical research and biotechnology companies devoted to discovering and developing medicines that enable patients to live longer, healthier and more productive lives.

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Saint Luke's Cancer Institute appoints new medical director

Friday, July 26, 2013 03:13 PM

Saint Luke's Cancer Institute (SLCI) has appointed Timothy J. Pluard, M.D., medical director. Pluard is associate professor of medicine at Washington University and clinical director, section of breast oncology at Siteman Cancer Center, a National Cancer Institute (NCI) designated Comprehensive Cancer Center, at Washington University/Barnes Jewish Hospital in Saint Louis, Mo.

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National Stroke Association teams with CureLauncher

Friday, July 26, 2013 08:36 AM

Michigan-based CureLauncher, developer of a patent-pending, proprietary clinical trial matching service, has entered an exclusive partnership with the National Stroke Association—an educational, prevention and advocacy group for individuals, their families and healthcare professionals confronting health issues related to strokes.

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Vivus board appoints new chairman, CEO

Wednesday, July 24, 2013 03:00 PM

Biopharmaceutical company Vivus’ board of directors has appointed Michael Astrue chairman and Anthony Zook chief executive officer.

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Aurora Research Institute launches new medical journal

Wednesday, July 24, 2013 02:56 PM

Wisconsin-based nonprofit Aurora Health Care’s Research Institute will launch a quarterly peer-reviewed research journal TheJournal of Patient-Centered Research and Reviews, with the first edition expected in early 2014. The journal will be available online with limited print copies.

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Rho hires vice president of operations

Wednesday, July 24, 2013 09:45 AM

CRO Rho has appointed Richard Koenig vice president of operations. Koenig has close to 30 years of operations management and clinical development experience, most recently as vice president of operations for ClinStar.

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Scientists find 3D structure of key drug target for diabetes

Wednesday, July 24, 2013 09:24 AM

An international team led by scientists at The Scripps Research Institute (TSRI), an independent, nonprofit organization focused on research in the biomedical sciences, has determined and analyzed the three-dimensional atomic structure of the human glucagon receptor. The receptor, found mainly on liver and kidney cells, helps regulate glucose levels in the bloodstream and is the target of potential therapeutic agents for type 2 diabetes.

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Oligomerix names senior director of chemistry

Wednesday, July 24, 2013 09:21 AM

Oligomerix, a privately held company focused on the discovery and development of disease modifying therapeutics for Alzheimer's disease (AD) and related neurodegenerative disorders, has appointed James Hendrix, Ph.D., senior director of chemistry.

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September 30

Novartis-Walgreens pilot study blurring the line between retail pharmacy, investigative site

CISCRP to launch traveling science museum exhibit to demystify clinical trial participation

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October

New growth and decline in Asia clinical trials
South Korea, Japan, China see big growth in 1572s, while India posts huge drop

Harnessing Big Data to transform clinical trials
From protocol to patient recruiting, data analytics can yield valuable insights

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September

Sponsors look to collaborate on comparator drugs
Co-therapies, comparators are in 60% of studies, cost $25m per company a year

Early adopters implement risk-based monitoring pilot programs
Experiments aim to offer long-term solutions, despite short-term uncertainties

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