DIA Biosimilars 2013

Articles Published in 2013

ACRES launches global clinical research network technology platform

Friday, August 23, 2013 11:32 AM

The Alliance for Clinical Research Excellence and Safety (ACRES), analytics company ViS Research and HealthCarePoint (HCP), will officially begin registering clinical research sites worldwide. This is the first step in the development of the ACRES Global Network of high-performing sites, part of an open, global system for clinical research. This network will ultimately include thousands of sites worldwide connected through a shared technology platform.

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Cenduit: Now with Patient Reminders

Boston Scientific completes enrollment in SuperNOVA clinical trial

Thursday, August 22, 2013 08:01 AM

Boston Scientifichas completed enrollment in the SuperNOVA trial, a global, single arm, prospective, multicenter trial evaluating the long-term (12 month) safety and effectiveness of the Innova Self-Expanding Stent System. This advanced stent system is designed for treating patients with a narrowing or blockage of the arteries above the knee, often associated with peripheral artery disease (PAD).

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CRF Health – eCOA Forum

Patricia Monteforte named president of Trio Clinical Resourcing

Wednesday, August 21, 2013 04:40 PM

Aptiv Solutions, a global biopharmaceutical and medical device development services company, has appointed Patricia Monteforte president of Trio Clinical Resourcing, an Aptiv Solutions subsidiary focused on clinical and regulatory staffing. Monteforte will leverage more than 25 years in the pharmaceutical industry and success leading CROs to assemble teams of clinical and regulatory professionals to deliver flexible resourcing solutions to meet the current and future challenges in the pharmaceutical and medical device industry.

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Navidea awarded NIH SBIR grant

Wednesday, August 21, 2013 04:19 PM

Navidea Biopharmaceuticals, a biopharmaceutical company focused on precision diagnostic radiopharmaceuticals, has been awarded a Small Business Innovation Research (SBIR) grant from the National Institute On Aging (NIA) of the NIH in connection with the company's phase III clinical program for its NAV4694 beta-amyloid imaging agent as an aid in the differential diagnosis of Alzheimer's disease.

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Neurodegeneration Consortium receives $5 million from Huffington Foundation

Wednesday, August 21, 2013 11:02 AM

The Huffington Foundation has committed $5 million to the Neurodegeneration Consortium (NDC), a multi-institutional collaboration to study and treat Alzheimer’s and other neurodegenerative diseases.

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Pancreatic Cancer Action Network study suggests national trial coordination needed

Wednesday, August 21, 2013 10:49 AM

The Pancreatic Cancer Action Network conducted a research study on the landscape of pancreatic cancer clinical trials in the U.S. in order to better understand how to accelerate clinical progress against pancreatic cancer and achieve the organization's goal to double the survival rate by 2020. The findings were published in the Journal of Clinical Oncology.

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Litera acquires AxxiTRIALS Clinical Trials Portal

Wednesday, August 21, 2013 10:30 AM

Litera has acquired AxxiTRIALS, a Clinical Trials Portal solution providing life science companies and CROs with a platform designed to speed site startup, patient recruitment and end-to-end clinical trial operations.

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Adimab, Celgene collaborate for antibody discovery

Wednesday, August 21, 2013 10:22 AM

Adimab, a technology company focuses on the discovery of fully human antibodies, has announced a multi-target discovery collaboration with Celgene of Summit, NJ. Adimab will use its proprietary platform to generate therapeutic antibodies against multiple targets. Celgene will have the right to develop and commercialize all therapeutic antibodies resulting from the collaboration.

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PSI expands to India, names Radhika Bobba regional director

Wednesday, August 21, 2013 10:16 AM

Privately-held, Switzerland-based CRO PSI  has expanded to India. PSI’s decided to conduct clinical trials in India based on client requests. The PSI Indian base is a hub for continuous expansion into the entire Asia-Pacific region.

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First patients enrolled in REMEDEE registry

Tuesday, August 20, 2013 09:58 AM

Patient enrollment has been initiated in a post-market registry for OrbusNeich’s COMBO Dual Therapy Stent to evaluate its long-term safety and performance in routine clinical practice. The prospective, multicenter, all-comers REMEDEE Registry (Multicenter, Prospective, Clinical Outcomes After Deployment of the Abluminal Sirolimus Coated Bio-Engineered Stent (Combo Bio-Engineered Sirolimus Eluting Stent) Post Market Registry) will enroll 1,000 patients at nine European sites. More than 100 patients have already been enrolled.

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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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The CenterWatch Monthly

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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