Theorem Clinical Research

United States

StemTech to open Florida facility, hire 90

Wednesday, March 19, 2014 12:55 PM

Stemtech International, a stem cell technology company, will move its headquarters from San Clemente, Calif., to Pembroke Pines, Fla., creating 90 jobs.

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MD Anderson, MedImmune collaborate on cancer immunotherapy

Monday, March 17, 2014 01:42 PM

The University of TexasMD Anderson Cancer Center and MedImmune, the global biologics R&D arm of AstraZeneca, will collaborate through MD Anderson's Moon Shots Program to develop therapies that unleash patients' immune systems to attack their cancers.

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University of Maryland School of Medicine, MRIGlobal collaborate

Monday, March 17, 2014 01:39 PM

MRIGlobal and the University of Maryland School of Medicine will collaborate in the development of clinical specimen repositories, laboratory services for clinical trials and research opportunities. The work will be performed under the collaboration agreement by MRIGlobal Dx, a division of MRIGlobal.

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PPD selected as member of new Medical Countermeasure Clinical Studies Network

Friday, March 14, 2014 11:18 AM

The Biomedical Advanced Research and Development Authority (BARDA) has chosen global CRO Pharmaceutical Product Development (PPD) as one of a select group to design and conduct clinical studies needed to develop medical countermeasures—drugs, vaccines and diagnostic tests—that help protect health against bioterrorism, pandemic influenza and other public health emergencies.

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Northwestern Memorial HealthCare, Cadence Health pursue merger

Friday, March 14, 2014 10:26 AM

Cadence Health and Northwestern Memorial HealthCare (NMHC) have agreed to discuss forming an integrated academic healthcare delivery system. Cadence Health is the corporate parent of Central DuPage Hospital and Delnor Hospital, and NMHC owns Northwestern Memorial Hospital and Northwestern Lake Forest Hospital.

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CFS Clinical sponsors STEM event

Thursday, March 13, 2014 01:33 PM

Statistics continue to show girls are not embracing careers in technology, despite an increasing need for skilled professionals in STEM (Science, Technology, Engineering and Math) fields in the nation. Girls Exploring Tomorrow’s Technology (GETT) promotes academic achievement in all girls in sixth to twelfth grade in the Delaware Valley and introduces them to the idea of potentially having a future in technology.

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ClinicalRM awarded BARDA contract

Thursday, March 13, 2014 12:57 PM

Clinical Research Management (ClinicalRM), a full-service CRO providing support for basic and applied research, clinical trials and regulatory support, has been awarded a contract by the Biomedical Advanced Research and Development Authority (BARDA). With this contract award, ClinicalRM becomes part of a clinical studies network being established by BARDA to support development of vaccines, drugs and diagnostics, known as medical countermeasures, needed to protect health and potentially save lives in public health emergencies. The network will provide clinical services in support of adequate and well-controlled phase I through IV clinical trials or trials during a public health emergency, and will support the evaluation of chemical, biological, radiological, nuclear, pandemic influenza and emerging infectious disease medical countermeasures.

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PhRMA launches national campaign to increase diversity in clinical trials

Thursday, March 13, 2014 12:55 PM

The Pharmaceutical Research and Manufacturers of America (PhRMA) and the National Minority Quality Forum have announced a first-of-its-kind national campaign to help increase diversity in clinical trials.

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Upsher-Smith receives FDA approval for Qudexy XR (topiramate)

Thursday, March 13, 2014 11:15 AM

Upsher-Smith Laboratories has received FDA approval for Qudexy XR (topiramate) extended-release capsules, a once-daily, broad-spectrum antiepileptic drug specifically engineered to deliver a smooth pharmacokinetic (PK) profile.  Qudexy XR is indicated as initial monotherapy in patients 10 years of age and older with partial-onset seizures (POS) or primary generalized tonic-clonic seizures.  It also is approved as adjunctive therapy in patients two years of age and older with POS, primary generalized tonic-clonic seizures and seizures associated with Lennox-Gastaut syndrome. Qudexy XR will be available to patients in the second quarter of 2014.

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NIH awards Seattle BioMed $9.8M to develop HIV/AIDS vaccine

Wednesday, March 12, 2014 02:54 PM

Seattle BioMed, an independent, nonprofit organization focused solely on infectious disease research, has received a seven-year Integrated Preclinical/Clinical AIDS Vaccine Development (IPCAVD) grant from the National Institute of Allergy and Infectious Diseases (NIAID) to develop a vaccine that would elicit broadly neutralizing antibodies against HIV-1.

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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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September

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

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CW’s first site focus groups uncover frustration with 'progress,' but a passion for their mission

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August

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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