Week of March 20, 2023

This week we look at a collaboration between two large pharma companies on an Alzheimer’s diagnostic, a major change in UK clinical trial regulations and a significant step to approval for an ALS (amyotrophic lateral sclerosis) drug. Finally, we highlight a promising breakthrough in brain implant technology and a mini robot that completed a surgery.

Each week we highlight five things affecting the life sciences industry. Here’s the latest.

Eli Lilly has been working on a blood test to detect Alzheimer’s disease for several years. The test is designed to identify patients most susceptible to Alzheimer’s so that they can be advised to seek confirmatory testing. This week, Roche announced that it would partner with Eli Lilly on this endeavor. The agreement comes at a key juncture as trials are about to begin with the goal of Food and Drug Administration approval by 2025.

The UK’s Medicines and Healthcare products Regulatory Agency announced this week that significant changes will be made to the clinical trial review process. The reforms will reduce the time from application to recruiting of patients by 40 days. Also, all applications must be reviewed within 30 days. Finally, there is a new requirement that all trials be registered with the World Health Organization. This is the largest regulatory overhaul announced by the MHRA in 20 years.

An FDA advisory panel voted this week that data on an ALS treatment indicates potential efficacy. This decision is a major step on the path to accelerated approval. While the panel was divided, its report indicated that the therapeutic shows reduced levels of protein neurofilament, an indicator of nerve degeneration. The next step is an application for accelerated approval. The FDA generally follows the advice of advisory panels when considering accelerated approval but they are not bound by such recommendations.

Swedish researchers have developed an injectable gel that solidifies into a soft, flexible electrode in the brain. This approach aims to address the problem of brain damage caused by traditional metal electrodes, which often lead to scarring and require removal after several years. The gel has been successfully tested in zebra fish and leeches, but challenges remain in transmitting signals to and from these electrodes for practical use.

A mini robot guided by magnets has been developed by researchers at the University of Michigan. Controlled remotely via a joystick-like device, the millimeter-sized robot performs precise surgical tasks, improving outcomes and reducing complications. This technology has the potential to revolutionize endovascular surgeries, making them safer and more accurate.

Source link: https://realeconomy.rsmus.com/5-things-to-know-in-life-sciences-week-of-march-20-2023/ by Justin Culbertson at realeconomy.rsmus.com