This week we spotlight the Food and Drug Administration’s improved decision times on 510(k) submissions. We also delve into a clinical trial that shows the effects of pitavastatin calcium on reducing cardiovascular events in people with HIV, as well as artificial intelligence systems for accurate blood tests. Additionally, we look at the discovery of a potentially new antibiotic and a new heart scanning technique to detect hypertrophic cardiomyopathy.
Each week we highlight five things affecting the life sciences industry. Here’s the latest.
Get more life sciences insights in our industry outlook.
Overall 510(k) approval times improve, but premarket backlog continues
During the first half of the year, the FDA successfully reduced the time it took to reach decisions on 510(k) submissions by 24 days compared to the previous year. The FDA aims to achieve an average decision time of 128-calendar days for 510(k) submissions in its 2023 financial year. However, the agency is still dealing with a backlog of premarket approval (PMA) applications caused by the pandemic. The average wait time for original PMA approval has increased by 84% over the previous year, reaching 1,013 days, the longest since data tracking began in 2012. Despite the progress in 510(k) submissions, the backlog in PMA filings continues to impact premarket approvals.
Daily statin reduces heart disease risk among adults living with HIV
A National Institutes of Health-funded clinical trial shows that pitavastatin calcium, a type of cholesterol-lowering medicine, may reduce the risk of adverse cardiovascular events in people living with HIV. These individuals can have a 50% to 100% increased risk for cardiovascular disease. The research found that participants who took the statin daily had 35% fewer major cardiovascular events than those who received a placebo.
AI-driven system provides highly accurate testing for chronic diseases
Prevencio, Inc., in collaboration with researchers from Massachusetts General Hospital, has developed the HART® platform, an AI-driven system that provides highly accurate blood tests for a broad range of patients, including those with chronic diseases. The platform includes two lead tests which assess a patient’s risk for heart attack, stroke or cardiovascular death, and the presence of heart artery obstructions. The tests have shown robust accuracy in over 1,250 patients, suggesting their potential for individualized cardiac risk assessment and proactive intervention.
New drug synthesis technique creates opportunities in antibiotic development
Antibiotics are a powerful and effective tool for fighting against bacterial infections. However, worldwide use of antibiotics has led to the emergence of drug-resistant bacterial strains. To fight these drug-resistant bacteria, researchers are continuously searching for new antibiotics. One of the most promising candidates is tanzawaic acid B, part of the tanzawaic acid family of organic polyketide compounds. Researchers have developed a new synthesis technique that has achieved the first total synthesis of tanzawaic acid B. This technique will provide a continuous, larger-scale supply of tanzawaic acids, which may play a key role in the development of new antibiotic drugs.
Researchers develop new heart scanning technique to detect deadly heart condition before symptoms appear
Scientists have developed a new method for detecting hypertrophic cardiomyopathy (HCM), a deadly heart condition. HCM is a leading cause of heart failure and affects approximately 1 in 500 people in the U.K. By combining two cutting-edge techniques, cardiac diffusion tensor imaging and cardiac magnetic resonance imaging perfusion, HCM can be detected before symptoms and signs on conventional tests appear.
