Theorem Clinical Research

United States

MedNet Solutions updates iMedNet eClinical

Friday, January 9, 2015 02:03 PM

MedNet Solutions, a Minnetonka, Minn.-based global life sciences technology company specializing in clinical study management systems, has updated iMedNet eClinical, its innovative, cloud-based technology platform. iMedNet said its software-as-a-service (SaaS) solution is intuitive, flexible and affordable for sponsors and CROs wishing to quickly and efficiently build studies themselves.

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Quest Diagnostics

Inovio Pharmaceuticals HIV immunotherapy shows vital characteristics

Thursday, January 8, 2015 02:28 PM

Inovio Pharmaceuticals has reported results from a 12-patient, phase I study of Inovio's HIV immunotherapy, PENNVAX-B, in HIV-infected patients revealed that immune response characteristics generated by the immunotherapy were similar to those observed in HIV-infected individuals who without treatment do not progress to further stages of the disease.

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FDA grants Soligenix Fast Track designation for SGX301 for lymphoma

Thursday, January 8, 2015 02:12 PM

Soligenix, a late-stage biopharmaceutical company developing products that address unmet medical needs in the areas of inflammation, oncology and biodefense, has announced that its SGX301 (synthetic hypericin) development program for the first-line treatment of cutaneous T-cell lymphoma (CTCL) has received Fast Track designation from the FDA.

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American Diabetes Association announces new national officers and board members

Thursday, January 8, 2015 01:54 PM

The American Diabetes Association, a voluntary health organization leading the fight to Stop Diabetes, has announced its officers and board of directors members for 2015.

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Carl Feldbaum joins Trovagene's board of directors

Thursday, January 8, 2015 01:17 PM

Trovagene, a developer of cell-free molecular diagnostics, has announced that Carl Feldbaum, president emeritus of the Biotechnology Industry Organization (BIO), a biotechnology trade association, has been appointed to its board of directors. He also will be chairman of the company's Corporate Governance and Nominating committee.

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Iodine launches cold and flu app to help consumers find best OTC options for their symptoms

Monday, December 22, 2014 02:06 PM

San Francisco-based Iodine, developer of health information web site Iodine.com, has launched a new web app for cold and flu season.

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14 indicted in connection with 2012 nationwide fungal meningitis outbreak

Friday, December 19, 2014 02:29 PM

The Justice Department unsealed a 131-count criminal indictment in Boston in connection with the 2012 nationwide fungal meningitis outbreak. Barry J. Cadden, owner and head pharmacist of New England Compounding Center (NECC), and NECC’s supervisory pharmacist Glenn A. Chin were charged with 25 acts of second-degree murder in Florida, Indiana, Maryland, Michigan, North Carolina, Tennessee and Virginia.   

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New FDA-sponsored research: National and international device registries needed

Thursday, December 18, 2014 11:23 AM

Most Americans will be exposed to a medical device during their lives and tens of millions will receive an implantable device. However, public health and regulatory agencies in the U.S. and internationally acknowledge there are gaps both in the ability to track these devices and to provide the public the accurate, evidence-based information consumers need to improve their health and make informed care decisions.

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FDA announces Pharmacy Compounding Advisory Committee members

Wednesday, December 17, 2014 12:29 PM

The FDA has announced the membership of the Pharmacy Compounding Advisory Committee. The committee is comprised of 14 members—12 voting and two non-voting—who will provide advice on scientific, technical and medical issues concerning drug compounding under sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act.

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Infraredx, Massachusetts General Hospital collaborate on cardiovascular imaging devices

Wednesday, December 17, 2014 12:26 PM

Infraredx, a Burlington, Mass.-based cardiovascular imaging company, is collaborating with Massachusetts General Hospital (MGH) and coronary imaging researcher Gary Tearney, M.D., Ph.D., professor of pathology at Harvard Medical School, Mike and Sue Hazard Family MGH Research Scholar and founder of the Tearney Lab at the Wellman Center for Photomedicine at MGH. The multi-year collaboration will focus on research and development of new and combination technologies that aim to provide enhanced information about coronary disease in patients.

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CWWeekly

March 2

Huntingdon Life Sciences-Harlan prepares for rebranding and U.S. expansion to compete with early phase CROs Covance, CRL

Patients' increased sharing of clinical trial experiences through social media can help sponsors improve outcomes, enrollment

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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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