DIA Biosimilars 2013

NeuroSigma

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

NeuroSigma awarded $680,000 NIH grant for TFN-covered stent

Monday, April 9, 2012 10:39 AM

NeuroSigma, a Los Angeles-based medical device company, has been awarded a phase I NIH-STTR grant from the National Institute of Neurological Disorders and Stroke (NINDS) for the further development of its Thin-Film Nitinol (TFN)-covered stent for the potential treatment of brain aneurysms. 

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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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The CenterWatch Monthly

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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