Clinical trials

The UK has brought in new rules it says will make it easier to get permissions to carry out clinical trials of medical devices, such as hip and knee replacements, pacemakers and stents.

The conclusion that there was nothing wrong with the specifics of the TeGenero trial in which six healthy volunteers ended up in intensive care has repercussions for the wider biotech industry.

Chroma Therapeutics Ltd raised £30 million in a third private round, giving the chromatin specialist funding for the next three years and enabling it to advance the lead programme through Phase II clinical studies and bring two further products into the clinic.

After finding nothing wrong with the specifics of the preclinical data, the product, or how the trial was conducted, the UK Medicines and Healthcare Products Regulatory Agency has ordered an investigation to changes in clinical trials procedures.