This week we look at new cybersecurity standards for medical devices, a newly identified trigger for mood disorders, an implantable insulin delivery system and the exit of a major player in the race for an RSV vaccine. Finally, we continue to watch developments in diversity considerations for clinical trials.
Each week we highlight five things affecting the life sciences industry. Here are the latest.
FDA issues new cybersecurity standards for medical devices
Several major medical device manufacturers have issued warnings to customers that cybersecurity threats could compromise medical data and other personal information. In response, the FDA issued new regulations requiring manufacturers of certain medical devices to submit detailed cybersecurity plans before receiving regulatory approval for their products. Specifically, companies will be required to detail how they will track potential cyberthreats, document internal processes to ensure cybersecurity at the time of product launch and monitor for subsequent vulnerabilities.
Researchers identify new trigger for mood disorders
Researchers in the United Kingdom have identified a new potential trigger for certain mood disorders including depression. Glycine, an amino acid and neutron transmitter, can transport a slow-down signal to the brain that may trigger mood changes. The research could lead to new treatments for mood disorders. Current anti-depressant drugs such as selective serotonin reuptake inhibitors (SSRIs) take several weeks to become effective; researchers are exploring whether targeting glycine could significantly reduce the time required for a treatment to have an impact.
Studies indicate promising early results for an implanted insulin delivery system
A group of Swiss scientists is working to develop an implantable insulin delivery system to treat diabetes that does not require regular replacement or recharging. They have devised a 3D carbon nanotube that detects high levels of glucose, and then converts that glucose into energy to power an insulin delivery system. If successful, this development would add an entirely new product to the insulin market, which currently relies on battery-operated external devices.
J&J abandons RSV vaccine trials
Johnson & Johnson this week said it would discontinue a global trial of a vaccine targeted at a lower respiratory disease. J&J had commenced the study of a drug to combat respiratory syncytial virus (RSV) in 2021 with more than 27,000 patients enrolled. In its press statement, the company said that after a portfolio review it would shift its focus to other assets. The news comes after Pfizer and GSK received support of an FDA panel for RSV vaccines this year.
Recent study shows clinical trial diversity is at a 10-year low
Clinical trial diversity continues to be a topic of discussion in the industry, and the FDA has made significant efforts to encourage diversity among trial participants. However, despite the amount of attention focused on addressing this issue, a recent study indicated that trial diversity is at its lowest point in 10 years. Certain indications including psychiatry, infectious disease and cardiology have seen an increase in trial diversity representative of the U.S. population. However, oncology trials, which account for over 40% of trial starts, lack a representative number of Black and Hispanic patients.
