Clinical Research

J&J Leads the Way in Developing a Rational Process for Responding to Compassionate Use Requests

Filed in Clinical Research, Drugs & Devices by on May 15, 2015 0 Comments
J&J Leads the Way in Developing a Rational Process for Responding to Compassionate Use Requests

By Carl H. Coleman Global pharmaceutical giant Johnson & Johnson announced last week that it had appointed Arthur Caplan, a prominent bioethicist, to establish a Compassionate-Use Advisory Committee (CompAC) to make decisions about patients’ requests for access to unapproved medications outside of clinical trials.  The decision is a welcome development that other companies would be […]

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Clinical Trials of Primary Care Drugs: Could Smaller Be Better?

Clinical Trials of Primary Care Drugs: Could Smaller Be Better?

Cross-Posted at Bill of Health Lately it seems that each passing day brings another article about the cost of orphan drugs.  Earlier this week at FiercePharma, Tracy Staton reported that the United Kingdom’s National Institute for Health and Clinical Excellence (NICE) has asked Alexion Pharmaceuticals to justify the price of its drug Soliris which is, per […]

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Potential Effects of Clinical Trial Data Sharing on Biopharmaceutical Innovation

Potential Effects of Clinical Trial Data Sharing on Biopharmaceutical Innovation

We are very pleased to welcome Dana Darst, a Master of Science in Jurisprudence candidate in Health Law and Intellectual Property Law here at Seton Hall, to the blog today. In recent years, biopharmaceutical research and development organizations have established partnerships with academic institutions and start-up biotechnology companies to drive external innovation, complementary to their own […]

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