Theorem Clinical Research

Global News

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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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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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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Survey: CROs exchange regulated clinical trial docs via outdated methods

Wednesday, October 8, 2014 01:38 PM

The vast majority of CROs surveyed lag behind sponsors in how they exchange trial master file (TMF) documents, according to a Veeva Systems survey, Veeva 2014 Paperless TMF Survey: The State of CRO TMFs.

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Epirus, Livzon Mabpharm collaborate in China

Wednesday, October 8, 2014 12:00 PM

Epirus Biopharmaceuticals, a Boston-based biopharmaceutical company focused on the global development and commercialization of biosimilar monoclonal antibodies, has signed a royalty-bearing, multi-product collaboration agreement with Livzon Mabpharm, a Chinese biotechnology company focused on the development, manufacture and sale of antibody-based drugs.

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Tenax Therapeutics halts phase IIb trial

Tuesday, October 7, 2014 01:00 PM

Tenax Therapeutics, formerly named Oxygen Biotherapeutics, a Morrisville, N.C.-based specialty pharmaceutical company focused on developing and commercializing a portfolio of products for the critical care market, has announced that the company, with unanimous approval from the board of directors, has elected to stop the current phase IIb trial for its Oxycyte drug candidate and consider strategic alternatives for the program moving forward. The company will review the data generated on the patients enrolled in the trial to date.

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Optos, NHS, academia collaborate on early detection device

Tuesday, October 7, 2014 11:30 AM

Optos, a U.K. medical retinal imaging company, has announced a $16 million collaboration with scientists and clinicians from NHS Greater Glasgow and Clyde, and the Universities of Kent and Strathclyde, for the development of a new imaging technology that could allow earlier detection of sight threatening eye disease. 

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PPD acquires X-Chem

Tuesday, October 7, 2014 10:30 AM

Pharmaceutical Product Development (PPD), a Wilmington, N.C.-based CRO, has exercised its option to acquire the remaining minority ownership interest of X-Chem. X-Chem, a biotechnology company based in Waltham, Mass., will continue to operate as a biotechnology company with its entire existing staff, including its management team led by CEO and founder Richard W. Wagner, Ph.D., along with executive management team members Diala Ezzeddine, Ph.D., chief business officer; Matthew Clark, Ph.D., sr. vice president of research; and Lee Babiss as chairman of the board.

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HUYA Bioscience International, Tianjin Institute of Pharmaceutical Research partner

Tuesday, October 7, 2014 09:30 AM

HUYA Bioscience International, an accelerator of the global development of China’s pharmaceutical innovations, has announced a joint venture with Tianjin Institute of Pharmaceutical Research (TIPR) to develop medical technologies and therapies, originating in both China and the western world, for global markets.

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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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