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    French Regulators Set Up Dedicated Unit for Overseeing Early Stage Clinical Trials

    France's Agence Nationale de Sécurité du Médicament et des Produits de Santé (ANSM) last week announced that it is setting up a new unit dedicated to overseeing first-in-human and other early stage clinical trials. The new unit is part of ANSM's action plan created in response to an incident during a first-in-human trial in France that left one patient dead and five others hospitalized in early 2016. The incident sparked an investigation by ANSM and a led to the Europe...
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    EMA Revises Guideline on First-in-Human Trials

    The European Medicines Agency (EMA), in cooperation with the European Commission and the EU member states, on Tuesday proposed revisions to its 2007 guideline on first-in-human clinical trials as part of an effort to further improve the safety of participants as trial protocols become increasingly complex. The  revised guideline , which is open for public consultation until 28 February 2017, is intended to further assist sponsors in the transition from non-clinical to ea...
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    FDA: Toxicity Seen in Fatal French Study Does Not Extend to Other FAAH Inhibitors

    The U.S. Food and Drug Administration (FDA) on Friday said that after reviewing the safety information of a first-in-human clinical trial in Rennes, France that resulted in the death of one healthy volunteer and the hospitalization of five others in January, the agency found that the toxicity exhibited in the trial does not extend to other drugs in the class, known as fatty acid amide hydrolase (FAAH) inhibitors. Working alongside the European Medicines Agency (EMA) and ...
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    EMA Begins Review of First-in-Human Trial Safety Following Patient Death

    The European Medicines Agency (EMA) on Friday said it's reviewing its standards for first-in-human clinical trials after an incident during a trial in France last January left one patient dead and five others hospitalized. The trial was conducted in Rennes, France by contract research organization Biotrial, on behalf of Portuguese pharmaceutical company Bial . During the trial, a patient was hospitalized five days after receiving an increased dose of Bial's investigati...
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    ANSM Committee Delves Into Nitty-Gritty of Fatal French Phase I Trial

    France’s National Agency for Medicines and Health Products Safety (ANSM) released a report this week outlining how its Temporary Specialist Scientific Committee (TSSC) evaluated what went wrong with a first-in-man clinical trial in Rennes, France that resulted in the death of one healthy volunteer and the hospitalization of five others in January. ANSM launched its investigation into the Phase I trial in January, which the contract research organization (CRO) running t...
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    Phase I Death in France: An Update on ANSM’s Investigations

    New information from France’s National Agency for Medicines and Health Products Agency (ANSM) was released this week on the Phase I clinical trial halted last month after the death of one healthy volunteer and the hospitalizations of five others. ANSM said Thursday that it “is pursuing its investigations in an aim to identify the factors which led to the dramatic accident which occurred 3 weeks ago .” The agency said this work is meant to supplement other investigation...
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    FDA Conferring With EU Counterparts on Trial Fiasco in France

    The U.S. Food and Drug Administration (FDA) announced Friday that it is conferring with European regulators, including the European Medicines Agency (EMA) and France's ANSM, after a Phase I trial resulted this week in the death of one enrolled subject and neurological injury to four others. FDA says no trials have occurred in the US with Bial’s BIA 10-2474, an inhibitor of fatty acid amide hydrolase (FAAH), an enzyme involved in cell function in the nervous system. That ...
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    EMA Will Assess ANSM Review of Botched Clinical Trial in France

    EU authorities could end up revising clinical trial guidelines depending on the outcome of French regulators’ investigation into Biotrial’s halted Phase I trial that has resulted in the death of one volunteer and the hospitalizations of five others. “The French authorities have opened an investigation including verification that the clinical trial has been carried out according to standards,” European Medicines Agency (EMA) spokeswoman Rebecca Harding told Focus . “EU a...