Theorem Clinical Research

United States

BloodCenter of Wisconsin launches next-generation sequencing HemeOnc Panel

Thursday, October 30, 2014 12:22 PM

BloodCenter of Wisconsin's Diagnostic Laboratories has announced the availability of a comprehensive cancer mutation HemeOnc Panel using next-generation sequencing (NGS) technology. The NGS panel is designed to detect variants in 30 genes that are either prognostic or diagnostic for 10 different myeloid hematologic malignancies.

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Booz Allen Hamilton acquires Epidemico

Thursday, October 30, 2014 12:15 PM

Booz Allen Hamilton, a Boston, Mass.-based provider of management consulting, technology and engineering services, has acquired Epidemico, a Boston informatics company.

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U.S. government institutes funding pause on gain-of-function research

Wednesday, October 29, 2014 01:39 PM

The U.S. government will undertake a deliberative process to assess the risks and benefits of certain gain-of-function (GOF) experiments with influenza, SARS and MERS viruses in order to develop a new federal policy regarding the funding of this research, announced Francis S. Collins, M.D., Ph.D., NIH director, in a statement. U.S. government agencies will institute a pause on the funding of any new studies involving these experiments.

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Cepheid, FIND, Rutgers collaborate on Xpert MTB/RIF test

Wednesday, October 29, 2014 01:22 PM

Cepheid, a Sunnyvale, Calif.-based molecular diagnostics company, FIND, a Switzerland-based international nonprofit organization and Rutgers New Jersey Medical School are collaborating to develop Xpert MTB/RIF Ultra, a next-generation test for Mycobacterium tuberculosis (TB) with increased sensitivity to aid in detection of patients with smear-negative TB, which often is associated with HIV co-infection. The collaboration also is receiving additional support from the National Institute of Allergy and Infectious Diseases at the NIH.

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NIH launches Illuminating the Druggable Genome to find potential drug targets

Wednesday, October 29, 2014 01:09 PM

NIH has announced a new collaborative initiative to improve human health by exploring poorly understood genes that have the potential to be modified by medicines. The effort is part of an NIH Common Fund three-year pilot project called Illuminating the Druggable Genome (IDG). For the initial phase of the program, NIH has allocated $5.8 million to eight institutions and for intramural resources.

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PharmaTimes launches 2015 Clinical Researcher of the Year competition

Wednesday, October 29, 2014 08:21 AM

The 2015 PharmaTimes Clinical Researcher of the Year-The Americas competition is open for entry. All research professionals are encouraged to enter.

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Burzynski Research Institute to launch diffuse intrinsic brainstem glioma trial

Monday, October 27, 2014 01:38 PM

Burzynski Research Institute (BRI) has announced that the FDA has given the company permission to conduct an open-label study of Antineoplastons A10 and AS2-1 in patients >3 months of age with a diffuse intrinsic brainstem glioma (DIPG).

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Synchrogenix appoints two new global submissions directors

Monday, October 27, 2014 01:30 PM

Synchrogenix Information Strategies, a regulatory writing company headquartered in Wilmington, Del., has added two new global submissions directors: Kelley Hill and Aaron Bernstein.

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FDA approves new treatment for rare form of hemophilia

Monday, October 27, 2014 01:24 PM

The FDA has approved Obizur [Antihemophilic Factor (Recombinant), Porcine Sequence] for the treatment of bleeding episodes in adults with acquired hemophilia A (acquired Factor VIII [FVIII] deficiency).

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SRI International opens clinical trial unit in Michigan

Monday, October 27, 2014 01:04 PM

SRI Biosciences, a division of SRI International, a California-based independent nonprofit research institute, has completed construction of an early-phase clinical trial facility in Plymouth, Mich. The 9,400-square-foot unit, located in the Michigan Life Science Innovation Center, now is open and fully equipped for early-stage human research studies of new medicines and medical devices. 

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October 27

NIH’s I-Corps boot camp aims to transform researchers into better businesspeople before they launch products

Covance, Frenova form partnership to share patient databases, find effective treatments for renal disease

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October

CROs driving changes in patient recruitment
Data- and tech-aided enrollment services a competitive advantage

Trials with in-home nurses poised to grow
Higher expense, but may improve recruitment and retention for select trials

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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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