05.02.2016 - It is not yet clear why a man died during a first-in-man clinical trial in January. However, a preliminary report found several “major shortcomings” by responsible CRO Biotrial. However, all regulations were complied with.
The initial shock has faded after one man died in a Phase I clinical trial conducted by Biotrial. The French CRO was tasked to find out whether a potential painkiller med was safe to use. During the trial, one of the volunteers became sick enough to be taken to hospital, where he later died. Following this, Biotrial could have acted more quickly and decisively, French health minister Marisol Touraine said, citing a report by investigators.
After the incident, the lab should have stopped the trial immediately, Touraine elaborated. A day after the man was hospitalised, other test subjects were still given the experimental medicine. Also, all volunteers taking part in the trial should have been informed of the incident immediately. And last but not least, the French drug safety agency should have been notified right away – not four days after the hospitalisation, and three days after the termination of the trial. “The event that occurred was serious enough to compromise the safety of the volunteers,” Touraine pointed out.
However, no regulations were breached, the minister continued. According to her, the investigators did not call for a suspension of Biotrial’s authorisation. However, the final results will only become available in late March.
The drug in question was an FAAH inhibitor developed by Portuguese pharma company Bial. Although there is no indication so far that FAAH inhibitors are unsafe, Janssen has suspended its own phase I trial of a drug with a similar mechanism. Other drug makers are continuing with their own trials, such as Pfizer, which has an FAAH blocker in phase II trials for several indications.
04.02.2016 After having dodged multiple takeover attempts by Monsanto last year, agrobusiness giant Syngenta has now agreed to be acquired by chemical corporation ChemChina. The Swiss company also announced plans to go public within a few years.
01.02.2016 Altering human DNA with the efficient gene editing method CRISPR/Cas9, especially germline modifications, was long considered a taboo. Now, however, UK scientists have received official approval to tinker with embryo DNA.
27.01.2016 Three UK universities have teamed up with three pharma companies to create the Apollo Therapeutics Fund. With the tech transfer fund, the consortium aims to develop scientific research into medicines.
25.01.2016 Affimed means to put a promising drug combination to the test. With support from MSD, the German biopharma will carry out clinical trials for an immunotherapy combining treatments of both companies.
21.01.2016 Stop squandering antibiotics and make research profitable again: at the World Economic Forum in Swiss Davos, 83 pharmaceutical companies have called for a unified approach towards the threat of antimicrobial resistance.