This week we look at the Food and Drug Administration’s approval of a virtual reality system to treat chronic lower back pain. We also explore a new round of anti-amyloid drugs seeking FDA approval to treat Alzheimer’s disease, a sustainable method to manufacture pharmaceuticals, another deal to license COVID-19 pills, and the FDA’s crackdown on overdue clinical trial results.
A quick reminder, next week we’ll pause publication due to the Thanksgiving holiday. We’ll resume the following week.
For now, this week we’ve highlighted five things you need to know in the life sciences industry. Here’s the latest.
FDA grants approval for virtual reality system to treat chronic back pain
This week the FDA granted approval for the EaseVRx virtual reality system to treat chronic lower back pain. The device intended for at-home and self-use employs cognitive and behavioral therapy techniques to help reduce symptoms. In trials, 66% of participants reported a greater than 30% pain reduction and 46% of participants reported a greater than 50% reduction. The approval is the first of its kind to leverage virtual reality, and most important, offers an opioid-free alternative to help manage the debilitating symptoms of chronic pain.
A new crop of anti-amyloid Alzheimer’s drugs are heading to the FDA
Just months after the controversial approval of Abduhelm by the FDA, a new round of drugs with similar mechanisms are being submitted to the agency. This is happening even before the dust has settled on Biogen’s drug as insurance companies, doctors and Medicare have determined under what circumstances they will pay for the newly approved drug. This begs the question of whether anti-amyloid drugs offer meaningful clinical benefit.
Chemistry breakthrough creates more sustainable pharmaceuticals
The majority of pharmaceutical manufacturing has shifted offshore over the past 30 years, with cost, EPA regulation and other waste considerations being a component of that decision. With the public and the markets pushing increased visibility into ESG (environmental, social and governance) reporting, emerging research from the University of Bath may provide a boost to the sustainability of pharmaceutical manufacturing. The researchers have developed a new method using blue light to create pharmaceuticals in a more sustainable way, significantly reducing the amount of energy needed and the chemical waste created in the manufacturing process.
Now two large pharma companies are licensing their COVID-19 pills
Following in Merck’s footsteps, Pfizer has inked a deal to license its COVID-19 pill with the Medicines Patent Pool, a public health organization backed by the United Nations. The license will cover 95 countries with 53% of the world’s population. According to the article, while the license does not convey manufacturing rights for sale outside of the noted countries, there is a path to selling beyond these countries through manufacturer licensing and sale in countries where a compulsory license has been issued.
FDA plans to address missing or late clinical trial data
According to the FDAAA trials tracker, only 75% or 8,900 of more than 11,800 clinical trials have been reported to the National Institutes of Health’s clinicaltrials.gov database. This means that there are approximately 3,000 unreported clinical trials. In addition, other analyses have indicated that 60% of clinical trials are not reported on time. This article examines some of the FDA’s posturing as it looks to improve clinical trial reporting.
