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Bristol-Myers Squibb, Novartis collaborate on NSCLC

Thursday, October 9, 2014 10:00 AM

Bristol-Myers Squibb has established a clinical trial collaboration to evaluate the safety, tolerability and preliminary efficacy of combining Bristol-Myers Squibb’s investigational PD-1 immune checkpoint inhibitor Opdivo (nivolumab) with three molecularly targeted oncology therapies (Zykadia (ceritinib), INC280 and EGF816) from Novartis. Novartis will conduct two phase I/II studies focused on non-small cell lung cancer (NSCLC).

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Bristol-Myers Squibb, MD Anderson Cancer Center collaborate

Thursday, October 9, 2014 09:30 AM

Bristol-Myers Squibb and the University of Texas MD Anderson Cancer Center have formed a novel clinical research collaboration to evaluate multiple immunotherapies, including Opdivo (nivolumab), Yervoy (ipilimumab) and three early-stage clinical immuno-oncology assets from Bristol-Myers Squibb, as potential treatment options for acute and chronic leukemia as well as other hematologic malignancies.

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Second Genome, Mayo Clinic collaborate to develop microbiome therapeutics

Thursday, October 9, 2014 09:00 AM

Second Genome, a South San Francisco, Calif.-based developer of novel medicines through innovative microbiome science, has entered into an extensive partnership with the Minnesota-based Mayo Clinic Center for Individualized Medicine to support the development of therapeutic products for multiple disease indications, starting with inflammatory bowel disease, metabolic disorders and colorectal cancer.

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NanoString, Brigham and Women's Hospital collaborate

Thursday, October 9, 2014 08:30 AM

NanoString Technologies, a Seattle, Wash.-based provider of life science tools for translational research and molecular diagnostic products, has signed a multi-year, multi-investigator research collaboration with Harvard-affiliated, Boston, Mass.-based Brigham and Women's Hospital (BWH) to accelerate the translation of genomic biomarker discoveries into clinical cancer diagnostics. Using NanoString's Elements reagents, assays will be developed to detect gene expression, copy number variations and fusions from a diverse range of tumor samples.

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Formex expands services, adds scientific staff and equipment

Thursday, October 9, 2014 08:27 AM

Formex, a pharmaceutical formulation developer and manufacturer, has expanded both scientific personnel and equipment.

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DPx to expand facility in North Carolina, add 488 jobs

Thursday, October 9, 2014 08:00 AM

DPx, the “umbrella name” for Patheon’s three business units specializing in pharmaceutical services, fine chemicals and proprietary products and technologies, will expand operations in Pitt County, N.C. The company plans to create 488 jobs in Greenville, N.C. by the end of 2019 and invest $159 million to increase the site’s capabilities, as well as modernize the site and develop energy efficiency programs at the facility.

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Survey: Global medtech industry needs to better differentiate products

Wednesday, October 8, 2014 01:53 PM

Despite ongoing commercial challenges in 2013, the global medtech industry's financial performance held steady at the relatively low levels of growth that have become common in recent years. But even as the industry grapples with these market and regulatory pressures, it faces a potential growing challenge—the threat of commoditization, according to new findings outlined in Ernst & Young's annual medical technology report, Pulseof the industry: differentiating differently.

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Teva announces results of strategic review of core specialty therapeutic areas

Wednesday, October 8, 2014 01:49 PM

Teva Pharmaceutical Industries has identified 14 pipeline projects for discontinuation or divestment as part of its strategic review of core therapeutic areas for the company. These projects amount to more than $150 million in R&D costs in 2015 and in excess of $200 million for each of 2016 and 2017.

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Allied Minds launches Novare Pharmaceuticals

Wednesday, October 8, 2014 01:47 PM

Allied Minds, a Boston, Mass.-based science and technology development and commercialization company, has launched Novare Pharmaceuticals, a biotechnology company focused on developing therapeutic products that help the body replenish and rebuild itself using its own tissue through the modulation of Receptor for Hyaluronan Mediated Motility (RHAMM). Modulation of RHAMM also is of benefit in inflammatory diseases such as bronchopulmonary dysplasia (BPD).

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Merck Serono to collaborate with Institute of Cancer Research, Wellcome Trust

Wednesday, October 8, 2014 01:42 PM

Merck Serono, the Germany-based biopharmaceutical division of Merck; the London-based Institute of Cancer Research (ICR); and the Wellcome Trust, a U.K. charitable foundation, have announced a co-development and license agreement building on two independent research programs at both the ICR and Merck Serono to identify inhibitors of tankyrase, an enzyme of the poly (ADP-ribose) polymerase family.

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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

From the trenches: Sites' eye view of state of the industry
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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