Theorem Clinical Research

Articles Published in 2011

China Health Resources completes research project developing innovative medicines

Monday, December 5, 2011 09:59 AM

China Health Resource, through its wholly owned subsidiary Suining Yinfa, has completed a key scientific research project in collaboration with Chengdu Chinese Traditional Medicine & Science University and the Sichuan Chinese Medicine Research Institute.

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Alexian Brothers Health System names president and CEO

Monday, December 5, 2011 09:48 AM

Mark A. Frey has been named president and chief executive officer of the Alexian Brothers Health System. He succeeds Brother Thomas Keusenkothen, C.F.A., who retired from the position on December 1, 2011.

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Report: Boston, N.J., Bay area lead nation’s top 16 life sciences clusters, all are growing

Monday, December 5, 2011 09:18 AM

Move over Boston, New Jersey and the San Francisco Bay area. Los Angeles and the Washington, D.C., region are quickly gathering steam as established life sciences hubs. And Minneapolis, Chicago, Denver, Houston, Florida, Atlanta and Indianapolis are among the emerging hubs not far behind. 

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FDA issues draft guidance on medical devices, launching pilot program with nine companies

Monday, December 5, 2011 09:15 AM

The FDA has issued two draft guidance documents that focus on early-stage development of medical devices. 

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H3 Biomedicine opens headquarters in Cambridge, Massachusetts

Friday, December 2, 2011 05:10 PM

H3 Biomedicine has opened a new headquarters and 24,000 square feet of state-of-the-art laboratory space in Cambridge, Massachusetts. Over the next year, the company plans to increase its staff to 70 people and further expand into more laboratory space within its building as it continues to pursue its mission to fulfill the promise of personalized cancer medicine.

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Celldex initiates phase III Rindopepimut trial

Friday, December 2, 2011 04:52 PM

Celldex Therapeutics has launched a phase III trial of rindopepimut in patients with surgically resected epidermal growth factor variant III (EGFRvIII)-positive glioblastoma, the "ACT IV Study." US investigators have started screening patients for inclusion in the trial that is expected to enroll up to 440 patients internationally to recruit 374 patients with Gross Total Resection (GTR) for the primary analysis. Rindopepimut is a therapeutic cancer vaccine candidate that targets the tumor-specific oncogene EGFRvIII, which confers an enhanced capacity for unregulated tumor growth and which is present in many cancer cell types, but not present at significant levels in normal cells.

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FDA issues draft guidance for artificial pancreas device systems

Friday, December 2, 2011 04:32 PM

The FDA has issued draft guidance designed to help investigators and manufacturers as they develop and seek approval for artificial pancreas device systems to treat type 1 diabetes.

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ADVENTRX meets with FDA to review ANX-188

Friday, December 2, 2011 04:23 PM

ADVENTRX Pharmaceuticals met with the FDA to review development plans for ANX-188 (purified poloxamer 188), the company's first-in-class treatment for sickle cell patients experiencing vaso-occlusive crisis.

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Nearly 90 medicines and vaccines in development for HIV/AIDS

Friday, December 2, 2011 03:51 PM

America’s biopharmaceutical research companies are testing 88 medicines and vaccines to treat or prevent HIV/AIDS and related conditions, according to a report by the Pharmaceutical Research and Manufacturers of America (PhRMA).

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Healthcare Team Training, IDEAS launch StoryCare

Friday, December 2, 2011 11:55 AM

Atlanta, GA-based Healthcare Team Training and IDEAS based in Orlando, FL, have partnered to launch StoryCare, the first enterprise-wide, staff-deployed teamwork simulation program using the power of story to measurably improve
patient safety and satisfaction.

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October 20

Toronto Star, with FDA data, exposes weaknesses in Health Canada's clinical trial, inspection oversight

Crowdsourcing effort aims to fund updated online social media guide for sponsor interaction with patients

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Today's fastest, most economical sponsors
Standout sponsors reveal how they shorten regulatory, clinical cycle times

From the trenches: Sites' eye view of state of the industry
CW’s first site focus groups uncover frustration with 'progress,' but a passion for their mission

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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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