Global News

The CenterWatch Monthly, July 2014

Tuesday, July 1, 2014 07:00 AM

IRB market consolidating rapidly

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WIRB Copernicus Group

Philips, salesforce.com ink agreement for cloud-based healthcare information technology

Monday, June 30, 2014 03:40 PM

Royal Philips, a healthcare technology company, and salesforce.com, a provider of customer relationship management software, have announced a strategic alliance to deliver an open, cloud-based healthcare platform, leveraging Philips' medical technology, clinical applications and clinical informatics and salesforce.com's experience in enterprise cloud computing, innovation and customer engagement.

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India’s generics industry hires consultant to boost image

Monday, June 30, 2014 03:38 PM

Companies specializing in generic pharmaceuticals in India and the U.S. have retained India First Group to promote the benefits of affordable access to medicine as vital to improving healthcare worldwide. India First Group is a strategic advisory firm based in Washington, D.C. and New Delhi that assists U.S. companies pursuing business opportunities in India and supports Indian companies investing in the U.S.

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FDA approves Afrezza to treat diabetes

Monday, June 30, 2014 02:29 PM

The FDA has approved Afrezza (insulin human) Inhalation Powder, a rapid-acting inhaled insulin to improve glycemic control in adults with diabetes mellitus. Afrezza is a rapid-acting inhaled insulin that is administered at the beginning of each meal.

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U.S. Oncology Research launches trial for preventing chemotherapy-induced hair loss

Monday, June 30, 2014 01:01 PM

U.S. Oncology Research—one of the largest community-based cancer research programs in the nation—and Baylor College of Medicine recently have launched a clinical trial to study a scalp cooling system designed to prevent chemotherapy-induced hair loss (alopecia). To date, 15 patients have been enrolled, and the study now is available at three U.S. Oncology Research sites.

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The Pulse on Global Trials

Monday, June 30, 2014 07:00 AM

At this month’s DIA annual meeting in San Diego, I gave a talk on leveraging the digital ecosystem for patient recruitment.

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Aurinia Pharmaceuticals initiates phase IIb trial of Voclosporin for lupus nephritis

Friday, June 27, 2014 01:19 PM

Aurinia Pharmaceuticals has enrolled the first patient in its planned phase IIb clinical trial to evaluate the efficacy of voclosporin as a treatment for lupus nephritis (LN). LN is an inflammation of the kidneys, that if inadequately treated can lead to end-stage renal disease, making LN a serious and potentially life-threatening condition. The Lupus Foundation of America believes there are as many as 1.5 million people in the U.S. with systemic lupus erythematosus (SLE), approximately 40% to 70% of whom will develop LN.

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Jennifer Doudna, Emmanuelle Charpentier win award for biomedical research

Friday, June 27, 2014 12:53 PM

Johnson & Johnson has named Dr. Jennifer Doudna of the University of California at Berkeley and the Howard Hughes Medical Institute, and Dr. Emmanuelle Charpentier, of the Hannover Medical School and Helmholtz Center for Infection Research (HZI), Germany and the Laboratory for Molecular Infection Medicine Sweden (MIMS), Umea University, Sweden, the winners of the 2014 Dr. Paul Janssen Award for Biomedical Research. Their collaboration led to the discovery of a new method for precisely manipulating genetic information in ways that should produce new insights in health and disease, and may lead to the discovery of new targets for drug development.

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Liomont, Oncobiologics partner to launch biosimilars in Mexico

Friday, June 27, 2014 11:13 AM

Oncobiologics, a privately held biopharmaceutical company, and Laboratorios Liomont, a Mexico City-based pharmaceutical company, have partnered for the development, manufacture and commercialization of biosimilar monoclonal antibody products for the Mexican market. The agreement includes exclusive commercialization in Mexico by Liomont of two biosimilars developed by Oncobiologics.

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Alzheimer's Drug Discovery Foundation, OnDeckBiotech partner

Friday, June 27, 2014 11:12 AM

The Alzheimer's Drug Discovery Foundation (ADDF) and OnDeckBiotech, a Boston-based software company providing software tools for biotech, pharma and R&D service vendors, are partnering to provide a new platform technology for ADDF ACCESS, an open-access database that provides a network of CROs, drug development consultants and educational resources focused for diseases of the central nervous system (CNS).

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CWWeekly

July 28

WCG acquires Alliance Biosciences to expand its biosafety oversight capabilities, ensure compliance

Facilitated review meetings for protocol design catching on, decreasing amendments, complexity

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The CenterWatch Monthly

August

Reality of costs and impact rain on Sunshine Act
Concerns mount over compliance burden on CROs, sponsors, unanticipated consequences for research

Cloud computing expanding into all areas of clinical trial conduct
Benefits outweigh the complexities, challenges of finding right vendors

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The CenterWatch Monthly

July

IRB market consolidating rapidly
Private equity driving a new commercial ethical review landscape

Lessons learned from medical device trials
Smaller, faster, more flexible trials hold important insights for pharmaceutical innovation

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