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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...
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    France’s ANSM Investigating Trial Halted After Five Patients Hospitalized, One Brain-Dead

    France’s National Agency for Medicines and Health Products Safety (ANSM) is currently investigating a Phase I clinical trial that’s been halted after the investigational drug caused brain damage in one healthy volunteer and hospitalized five others. The trial, conducted in the northwestern city of Rennes, France, was run by the contract research organization Biotrial with a total of 90 volunteers for the sponsor Bial, a Portuguese company. The investigational drug involv...