Theorem Clinical Research

Articles Published in 2011

Covidien to launch spin-off pharmaceuticals business

Thursday, December 15, 2011 02:27 PM

Covidien, a global provider of healthcare products, plans to spin off its pharmaceuticals business into a standalone public company.

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CROs form Asia CRO Alliance

Thursday, December 15, 2011 01:43 PM

Six Asian CROs have founded the Asia CRO Alliance (ACA) to combine regional expertise and provide integrated services across Asia. According to the ACA web site, it is the first and only alliance of niche, regional CROs in Asia to partner to enhance clinical research inAsia.

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CHIN to accelerate development of new vaccines and therapies

Thursday, December 15, 2011 09:05 AM

Seven universities, led by The University of Western Ontario, have been awarded a $600,000 catalyst grant from the Canadian Institutes of Health Research (CIHR) to create a national network to promote and enhance research on the body’s immune system. 

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Trillium launches phase I IC/BPS study

Thursday, December 15, 2011 08:31 AM

Trillium Therapeutics will begin a phase I clinical trial of its experimental drug, TTI-1612, in patients with interstitial cystitis/bladder pain syndrome (IC/BPS). The company has recently received a No Objection Letter to its Clinical Trial Application from Health Canada's Biologics and Genetic Therapies Directorate. The single ascending dose trial, which will be conducted at multiple sites across southern Ontario, will evaluate the safety and tolerability of TTI-1612 in IC/BPS patients.

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Molecular Imaging partners with Dana-Faber Cancer Institute

Thursday, December 15, 2011 08:15 AM

Molecular Imaging has entered into a licensing agreement with Dana-Farber Cancer Institute to access a substantial number of luciferase-enabled cancer cell lines developed at Dana-Farber. Access to these lines expands Molecular Imaging’s ability to apply bioluminescent imaging technology to a broad array of cancer disease models, including expanded capability in various leukemias, multiple myeloma, triple-negative breast cancer, glioma and melanoma.  

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Bristol-Myers Squibb, Simcere partner to develop cardiovascular compound

Wednesday, December 14, 2011 04:35 PM

Bristol-Myers Squibb and Simcere Pharmaceutical Group have expanded the strategic partnership formed last year to include a second collaboration in a different therapeutic area. The companies agreed to co-develop BMS-795311, Bristol-Myers Squibb's preclinical small molecule inhibitor of the Cholesteryl Ester Transfer Protein (CETP).  Inhibiting CETP could potentially raise HDL levels and help prevent cardiovascular disease.

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Nektar initiates phase III BEACON trial in women with metastatic breast cancer

Wednesday, December 14, 2011 04:17 PM

Nektar Therapeutics has initiated a phase III global clinical trial evaluating NKTR-102 as a single agent in women with metastatic breast cancer. NKTR-102 is a next-generation topoisomerase I inhibitor designed using Nektar's proprietary polymer conjugate technology, and is being developed in multiple tumor settings. The BEACON study is designed to include approximately 840 metastatic breast cancer patients who have had prior treatment with anthracycline, taxane and capecitabine in either the adjuvant or metastatic setting.

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Russia's cancer drug market to grow to $163 million

Wednesday, December 14, 2011 12:48 PM

Decision Resources, a research and advisory firm for pharmaceutical and healthcare issues, has found that the Russian market for non-small-cell lung cancer therapies will grow 3% annually from 2010 to 2015 to $163 million in 2015. According to the Emerging Markets report, Non-Small-Cell Lung Cancer in Russia, an increase in the incident population, gradually increasing use of higher-priced chemotherapies and the introduction of several premium-priced agents will promote this growth.

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Clarient, ACORN collaborate to improve cancer treatment

Wednesday, December 14, 2011 12:22 PM

Clarient, a GE Healthcare company, and ACORN Research have formed a strategic collaboration around molecular testing of tumor samples. The agreement will establish a standardized testing protocol across the ACORN network of oncology community practices and hospitals with treatment guidelines and clinical trial opportunities. These processes have the potential to improve oncology treatment and research that aim to deliver targeted treatments based on the specific genetic markers for each patient.

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AVI BioPharma names senior VP

Tuesday, December 13, 2011 12:18 PM

AVI BioPharma has named Jayant Aphale, Ph.D., senior vice president of technical operations. Aphale will have responsibility for all of AVI's internal and outsourced manufacturing activities, with an emphasis on technology transfer, scale-up, CMC compliance, CMC regulatory issues, and CMC project management from initial development through commercial production.

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September 2

Roche's $8.3B InterMune buy continues its buying spree with 'bolt-on' deal, fueling record M&A activity

FDA action plan seeks to close gap in women and minority patient representation in clinical trials

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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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July

IRB market consolidating rapidly
Private equity driving a new commercial ethical review landscape

Lessons learned from medical device trials
Smaller, faster, more flexible trials hold important insights for pharmaceutical innovation

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