Theorem Clinical Research

Global News

Survey: CROs exchange regulated clinical trial docs via outdated methods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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Report: 310M diabetics with smart devices in 2018

Tuesday, October 7, 2014 09:00 AM

For the diabetes app industry, the addressable market will be 310 million diabetics with smart devices in 2018, according to the Diabetes App Market Report 2014, released by ReportsnReports.com.

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Actavis to acquire Durata Therapeutics

Monday, October 6, 2014 04:00 PM

Actavis, a global specialty pharmaceutical company based in Dublin, Ireland, and Durata Therapeutics, an innovative pharmaceutical company focused on the development and commercialization of novel therapeutics for patients with infectious diseases and acute illnesses, headquartered in Chicago, Ill., have entered into a definitive merger agreement.

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FDA seeks permanent injunction against Pharmaceutical Innovations

Monday, October 6, 2014 03:46 PM

The FDA is seeking a permanent injunction to stop Pharmaceutical Innovations, and its principal officer, Gilbert Buchalter, from manufacturing, marketing, selling and distributing medical products until they come into compliance with all applicable FDA requirements.

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Ab Sciex, Illumina collaborate to create multi-omics cloud-computing environment

Monday, October 6, 2014 03:43 PM

Ab Sciex, a Framingham, Mass.-based global provider of mass spectrometry products, and San Diego, Calif.-based Illumina, a global provider of sequencing and array-based technologies, have announced the OneOmics project, an exclusive partnership to bring together SWATH-based next-generation proteomics (NGP) and next-generation sequencing (NGS) tools in a cloud computing environment.

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October 27

NIH’s I-Corps boot camp aims to transform researchers into better businesspeople before they launch products

Covance, Frenova form partnership to share patient databases, find effective treatments for renal disease

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October

CROs driving changes in patient recruitment
Data- and tech-aided enrollment services a competitive advantage

Trials with in-home nurses poised to grow
Higher expense, but may improve recruitment and retention for select trials

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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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