Theorem Clinical Research


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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Quest Diagnostics

Report: Antibiotics pipeline boasts 741 products, first-in-class development remains low

Wednesday, March 25, 2015 03:17 PM

While antibiotics boast a vast pipeline, with 741 products currently in development, the majority is dominated by generics, as weak financial incentives and high failure rates have discouraged innovation, said business intelligence provider GBI Research, a New York-based provider of business intelligence reports.

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Neovacs forms U.S. subsidiary

Wednesday, March 25, 2015 02:55 PM

Neovacs, a Paris-based biotechnology company focused on autoimmune and inflammatory diseases, has established a wholly-owned U.S. subsidiary, Neovacs Inc. Neovacs Inc. is headquartered in Boston and has been incorporated in Delaware.

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Paidion Research, a new pediatric CRO, launches

Wednesday, March 25, 2015 02:48 PM

Paidion Research, a new CRO focused exclusively on pediatrics and specializing in NICU and PICU populations (neonatal and pediatric intensive care), recently opened for business. Headquartered in Durham, N.C., Paidion combines pediatric clinical pharmacology experience with innovative pediatric regulatory strategies and trial methodologies to provide best-in-class service to drug and device development partners in industry, government, academia and nonprofits.

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Report: Clinical trial sponsors fail to report results to participants, public

Monday, March 16, 2015 01:52 PM

Despite legal and ethical mandates for disclosure, results from most clinical trials of medical products are not reported promptly on a registry specifically created to make results of human studies publicly available, according to Duke Medicine researchers.

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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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Icon rides latest outsourcing wave with launch of medical device and diagnostics research group

Friday, March 13, 2015 12:26 PM

Global CRO Icon has packaged a combination of its services to create a medical device and diagnostics research group designed to provide global clinical trials, health economics and pricing and market access tools.

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NIH-led study to assess community-based Hepatitis C treatment in Washington, D.C.

Thursday, March 12, 2015 12:52 PM

Officials from the National Institutes of Health and the city of Washington, D.C., launched a clinical trial to examine whether primary care physicians and other health care providers, such as nurse practitioners and physician assistants, can use a new antiviral therapy as effectively as specialist physicians to treat people with hepatitis C virus (HCV) infection. The trial, which will involve 600 adult D.C. residents infected with HCV alone or co-infected with HCV and HIV, also will examine the long-term effects of the treatment.

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CardioCell adds Stony Brook University to sites conducting phase IIa trial

Thursday, March 12, 2015 12:31 PM

CardioCell, a Stemedica Cell Technologies subsidiary that designs allogeneic stem-cell therapies for cardiovascular indications, has expanded patient recruitment to Stony Brook University’s Heart Institute for its phase IIa clinical trial for chronic heart failure (HF). Recruitment for 20 qualified patients currently is underway at only Emory University in Atlanta, Northwestern University in Chicago, Stony Brook University on Long Island and the University of Pennsylvania in Philadelphia.

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Biosimilars Provide New Business Opportunities for Sites

Monday, March 9, 2015 08:00 AM

Significant factors involved in the growth and potential impact of biosimilars include budgetary pressures to reduce healthcare expenditures, patent expiries of blockbuster drugs, growing demand for low-cost alternatives, an increasingly aging population, government initiatives and rising incidences of various diseases.

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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


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


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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