DIA Biosimilars 2013

United States

Soligenix completes phase I in SGX203 for pediatric Crohn’s

Wednesday, July 3, 2013 08:50 AM

Soligenix, a clinical stage biopharmaceutical company focused on developing products to treat inflammatory diseases and biodefense countermeasures where there remains an unmet medical need, has enrolled and treated all patients in the phase I study BDP-PCD-01, a clinical study for development of SGX203 (oral beclomethasone 17,21-dipropionate or oral BDP) for the treatment of pediatric Crohn's disease. The SGX203 development program previously has received Fast Track and Orphan Drug designations from the FDA.

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Cenduit: Now with Patient Reminders

Texas A&M launches Whole Systems Genomics Initiative

Wednesday, July 3, 2013 08:37 AM

Texas A&M University has announced the Whole Systems Genomics Initiative (WSGI), a strong faculty-conceived program developed as part of the Chancellor's Research Initiative (CRI) to define the future of genomic science, enabling researchers to address some of the most pressing challenges facing modern society through innovative and collaborative scholarly programs.

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CRF Health – eCOA Forum

Moffitt Cancer Center finds language, cultural barriers prevent Hispanic participation in trials

Tuesday, July 2, 2013 03:23 PM

Hispanic cancer patients rarely participate in clinical trials, but researchers want to tailor a Spanish DVD to help change this. To create a relevant educational tool, researchers at the Moffitt Cancer Center in Tampa, Fla., investigated why awareness of and participation in trials are so low in this population.

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Boston Scientific to acquire C.R. Bard’s electrophysiology business

Tuesday, July 2, 2013 01:11 PM

Boston Scientific, a global medical technology company, will acquire Bard, the electrophysiology (EP) business of C.R. Bard, for $275 million in cash.

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Forte Research Systems releases Allegro enhancements

Friday, June 28, 2013 02:07 PM

Forte Research Systems, developers of clinical trial management software, has announced the latest release of Allegro CTMS, which contains features that provide an enriched user experience and optimized operations management.

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WIRB-Copernicus Group, UL Quality, Compliance and Learning partner

Friday, June 28, 2013 01:50 PM

The WIRB-Copernicus Group (WCG), a provider of regulatory and ethical review services for human research, has partnered with UL Quality, Compliance and Learning (formerly EduNeering), a technology-driven compliance learning solutions company, to bring educational opportunities to clinical research professionals.

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BRANY, ViS Research partner to streamline feasibility

Friday, June 28, 2013 01:45 PM

The Biomedical Research Alliance of New York (BRANY), a network of clinical research sites in the U.S., has collaborated with ViS Research, which offers an online research feasibility platform that eliminates feasibility questionnaires, to help researchers by reducing their administrative tasks related to feasibility questionnaires while providing faster and easier trial startup.

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Seattle Genetics, Bayer in ADC collaboration

Wednesday, June 26, 2013 03:13 PM

Biotech Seattle Genetics has entered into an antibody-drug conjugate (ADC) collaboration with Bayer HealthCare. Bayer will pay upfront and option exercise fees of up to $20 million for worldwide rights to utilize Seattle Genetics' auristatin-based ADC technology with antibodies to several oncology targets. Seattle Genetics also is eligible to receive up to $500 million in potential milestone payments, as well as royalties on worldwide net sales of any resulting products under the multi-target collaboration. Bayer is responsible for research, product development, manufacturing and commercialization of all products. 

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Biotech salaries in San Francisco Bay area lead nation

Wednesday, June 26, 2013 02:42 PM

Denver-based BioSpace, a source for biotech and life sciences news and recruitment, has released its inaugural Bay Area Hiring and Salary Report showing that the San Francisco area leads four of the nation's biotechnology regions in average salary.

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CryoLife receives conditional IDE approval

Tuesday, June 25, 2013 03:45 PM

CryoLife, a tissue processing and medical device company focused on cardiac and vascular surgery, has received conditional approval of its Investigational Device Exemption (IDE) for PerClot from the FDA.

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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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