BC Innovations | Aug 2, 2018
Tools & Techniques

Model firsts

By combining disparate data into coherent mechanistic models, quantitative systems pharmacology is becoming a key tool for picking the right dose for first-in-human trials and other early make-or-break decisions. Advocates see it as part of...
BC Extra | Jun 9, 2017
Clinical News

Team describes off-target effects of Bial's FAAH inhibitor

In a paper published in Science , researchers characterized off-target activities of fatty acid amide hydrolase (FAAH) inhibitor BIA 10-2474 that they say may have played a role in the compound’s clinical neurotoxicity that led to...
BC Extra | Aug 12, 2016
Clinical News

FDA: Bial-Portela's FAAH inhibitor has "unique toxicity"

In its safety review of fatty acid amide hydrolase ( FAAH ) inhibitors, FDA concluded that BIA 10-2474 from Bial-Portela & Ca. S.A. (S. Mamede do Coronado, Portugal) "exhibits a unique toxicity that does not extend to...
BC Extra | Mar 11, 2016
Politics & Policy

French group outlines first-in-man trial precautions

A special committee created by the French National Agency for Medicines and Health Products Safety (ANSM) made initial recommendations for first-in-man trials following a death and several hospitalizations of healthy volunteers in a Phase I...
BC Week In Review | Feb 1, 2016
Clinical News

BIA 10-2474: Phase I halted

The French Health Ministry said a placebo-controlled, French Phase I trial of the oral analgesic BIA 10-2474 in 116 healthy volunteers has been halted after 6 subjects were hospitalized with serious “neurological troubles,” including 1...
BC Extra | Jan 21, 2016
Clinical News

Janssen halts trials of FAAH inhibitor

The Janssen Research & Development LLC unit of Johnson & Johnson suspended dosing of fatty acid amide hydrolase ( FAAH ) inhibitor JNJ-42165279 in two Phase II trials. The decision follows the death of a healthy volunteer...
BC Extra | Jan 16, 2016
Clinical News

One volunteer brain-dead in Bial trial

The French Health Ministry said a Phase I trial of the oral analgesic BIA 10-2474 from Bial-Portela & Ca. S.A. (S. Mamede do Coronado, Portugal) has been halted after several healthy volunteers were hospitalized with...
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