Global News

Ireland reiterates bid to host the EMA

Wednesday, May 10, 2017

Ireland has stepped up its bid to host the EMA with the official announcement being delivered and reiterated by Minister of Health, Simon Harris. The next step will now see Dublin scrutinized closely, particularly in regard to its regulatory capability. Ireland’s strength lies in the close relationship that the Health Products Regulatory Authority (HPRA) has established with the EMA and the wider network of medicines regulatory agencies throughout the EU. The HPRA has been an integral part of this regulatory system since the EMA was founded more than two decades ago.

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AG Mednet launches endpoint adjudication technology Judi for data quality

Wednesday, May 10, 2017

AG Mednet continues its drive to advance clinical trials with the launch of Judi, a comprehensive electronic endpoint adjudication system to manage workflow and ensure data quality. Judi helps sponsors and CROs manage clinical events from trigger to final adjudication in pharmaceutical, biologic and medical device clinical trials. This product capitalizes on AG Mednet’s experience delivering software in support of zero-delay clinical trials. AG Mednet is a specialized, electronic data collection and submission service dedicated to increasing data quality and reducing queries in clinical trials.

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Horizon Pharma to acquire River Vision Development

Wednesday, May 10, 2017

Horizon Pharma, a biopharmaceutical company focused on improving patients’ lives by identifying, developing, acquiring and commercializing differentiated and accessible medicines that address unmet medical needs, has agreed to acquire River Vision Development and its development-stage medicine teprotumumab (RV001), a fully human monoclonal antibody (mAb) currently in development for thyroid eye disease (TED), a rare, autoimmune inflammatory disorder.

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Agilis Biotherapeutics expands Commercial, Medical Teams

Tuesday, May 9, 2017

Agilis Biotherapeutics, a biotechnology company advancing innovative gene therapy products for the treatment of rare genetic diseases that affect the central nervous system (CNS), has expanded its commercial and medical teams, hiring Markus Peters, Ph.D., as chief commercial officer; Kirsten Gruis, M.D., as chief medical officer; and Anne Marie Conway, M.H.A, R.N., as vice president, Clinical Operations.

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ERT acquires imaging solution from Cleveland Clinic

Tuesday, May 9, 2017

ERT, a global data and technology company that minimizes uncertainty and risk in clinical trials, acquired ImageIQ, originally established as Cleveland Clinic’s Biomedical Imaging and Analysis Center. The acquisition enables ERT to offer advanced, end-to-end clinical trial imaging analysis using best-in-class technology that delivers compliant data for use in clinical development.

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