Theorem Clinical Research

United States

National Institute of Mental Health issues strategic plan for research

Thursday, March 26, 2015 02:57 PM

The National Institute of Mental Health (NIMH) has issued a new strategic plan for research. Informed by the successes and challenges of recent years, the new plan updates the strategic objectives of its 2008 predecessor with the aim of balancing the need for long-term investments in basic research with urgent mental health needs.

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Quest Diagnostics

FDA approves treatment for inhalation anthrax

Thursday, March 26, 2015 02:31 PM

The FDA has approved Anthrasil, Anthrax Immune Globulin Intravenous (Human), to treat patients with inhalational anthrax in combination with appropriate antibacterial drugs.

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Forbes Names Quintiles One of America’s Best Employers

Thursday, March 26, 2015 02:26 PM

Quintiles, a biopharmaceutical services company, has been named to Forbes magazine’s first-ever America’s Best Employers list as rated by more than 20,000 independent survey responses. 

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Cancer Innovation Coalition focuses on Precision Medicine Initiative

Wednesday, March 25, 2015 03:02 PM

The Cancer Innovation Coalition (CIC) has called on government leaders to put patients first when introducing new legislation and implementing President Obama's Precision Medicine Initiative.

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Selten Pharma receives FDA Orphan Drug designation for PAH

Thursday, March 19, 2015 01:13 PM

Selten Pharma, a privatively held biopharmaceutical company focused on the development and commercialization of therapies for the treatment of rare diseases, has announced its lead compound tacrolimus (SPI-026) has been granted Orphan Drug designation by the FDA for the treatment of pulmonary arterial hypertension (PAH).

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Tute Genomics, Google Genomics collaborate on genetic database

Thursday, March 19, 2015 12:03 PM

Tute Genomics, a Utah­-based provider of a clinical genome interpretation platform, along with Dr. Xiaoming Liu and his team at the University of Texas, have teamed up with Google to grant public access to a database of 8.5 billion annotations of genetic variants through Google Genomics.

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CRF Health launches eCOA solution for global diabetes trials

Wednesday, March 18, 2015 01:17 PM

CRF Health, a global provider of eCOA solutions for the life sciences industry headquartered in Plymouth Meeting, Pa., has launched a complete TrialMax eCOA solution for diabetes clinical trials. Developed with clinicians and patients to optimize usability and compliance, the solution enables investigators to collect patient reported outcome assessments and deliver defensible data, while minimizing patient and site burden. Already being used in four major global diabetes trials, covering 700 investigative sites and 3,250 patients, the solution offers complete integration between patient eDiary entry and blood glucose measurements.

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HealthCarePoint completes CDISC BlueCloud transnational commerce system

Monday, March 16, 2015 01:46 PM

HealthCarePoint (HCP), a Texas-based healthcare and clinical research networking-technology company, has completed development of the BlueCloud commerce system for the Clinical Data Interchange Standards Consortium (CDISC), a global nonprofit charitable organization.

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XBiotech launches cancer patient directed web site and call center

Monday, March 16, 2015 09:00 AM

XBiotech, an Austin, Texas-based developer of next generation therapeutic antibodies, has launched a web site and call center to help patients with metastatic colorectal cancer learn about its U.S. pivotal phase III clinical trial. The phase III study, Xilonix Colorectal cancer Immunotherapy Treatment Evaluation (XCITE), assesses XBiotech's True Human monoclonal antibody (Xilonix) for the treatment of metastatic colon cancer.

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Report: U.S. prescription drug spending increased 13.1% in 2014

Thursday, March 12, 2015 12:56 PM

New hepatitis C therapies with high price tags and the exploitation of loopholes for compounded medications drove a 13.1% increase in U.S. drug spending in 2014—a rate not seen in more than a decade—according to new data released in the 2014 Express Scripts Drug Trend Report. Headquartered in St. Louis, Mo., Express Scripts provides integrated pharmacy-benefit management services.

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CWWeekly

March 23

Industry welcomes FDA draft guidance outlining the use of electronic Informed Consent for trials

Apple launches ResearchKit platform to tap millions of iPhone users to enroll in observational studies using apps

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The CenterWatch Monthly

March

Novo Nordisk, Takeda, Servier, Celgene among top sponsors
New gains seen from patient- and site-centric initiatives

Patient reported outcomes take center stage
FDA combining PROs, clinical outcomes in its approval decisions

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The CenterWatch Monthly

February

Study grants market breaks $13 billion
Volume of clinical activity rising while growth in grant spending slows

Revisiting eClinical Technology Solutions Adoption
While use of established solutions grows, sponsors hesitate on newer tools

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