This week we highlight the challenges related to hepatitis B treatments and the U.S. Food and Drug Administration’s advisory committee meeting regarding timely accelerated approval confirmations. We also look at a new study that highlights COVID-19 rebounds and the exodus of life sciences researchers from academia. Additionally, we explore the debate on GLP-1 devices on the medtech sector.
Each week we highlight five things affecting the life sciences industry. Here’s the latest.
Despite recent progress, treatments for hepatitis B treatments lag behind those of other liver indications
Biotech firms are facing challenges in treating viral liver infections, particularly the transition from addressing hepatitis C to tackling hepatitis B, according to Fierce Biotech. Despite some recent advancements in hepatitis B treatments, economic constraints and historical under-prioritization of hepatitis B pose obstacles. Recent industry developments, such as strategic acquisitions and positive data from clinical trials, suggest a renewed focus on hepatitis B research, even as investor attention appears to be shifting toward other liver diseases such as nonalcoholic steatohepatitis.
FDA’s oncology office uses advisory committee to spotlight timely accelerated approval confirmation
The FDA’s oncologic drugs advisory committee is set to remind cancer drug developers about the importance of timely completion of confirmatory trials for drugs granted accelerated approval at a meeting this week. Per Fierce Pharma, the committee will discuss two drugs, approved in 2009 and 2014, which have yet to provide confirmatory trial data to verify their clinical benefits, with final data not expected until 2030. The FDA is emphasizing the need for quicker verification of clinical benefits to maintain early access to promising oncology products. This heightened scrutiny follows previous industrywide evaluations and aims to minimize the period of vulnerability between accelerated approval and confirmation of efficacy. The FDA’s recent legislative empowerment has led to requiring that confirmatory trials be underway at the time of approval.
New study shows one in five experience rebound COVID after antiviral drug
A new study by Harvard Medical School researchers reveals that 20% of individuals treated with a specific antiviral drug for severe COVID-19 symptoms experienced a viral rebound, characterized by a positive test result and the shedding of live, potentially contagious virus after initial recovery. This rate of rebound is significantly higher than previously thought, with only 2% of those not taking the drug experiencing similar symptoms. The study, which was not a randomized controlled trial, suggests that patients on this antiviral medication may remain contagious for longer periods. Despite these findings, the drug remains highly effective in preventing hospitalizations and deaths, and the study emphasizes the importance of patient counseling about the potential for viral rebound and transmission.
Exodus of life sciences researchers from academia to industry and the impact on scientific progress
There has continued to be a significant shift in the life sciences field, where an increasing number of researchers are leaving academia for more lucrative private sector jobs, according to STAT. Academia is struggling to recruit and retain postdoctoral researchers, leading to unexplored research ideas, unused grant funds, and delayed projects. This article from STAT cites National Science Foundation data showing a decline in life sciences Ph.D. graduates pursuing postdocs and an increase in those joining the industry. This shift raises concerns about the long-term health of academic research, which is crucial for early discoveries that lead to advanced treatments and diagnostics. The article also touches on the challenges faced by faculty in maintaining productivity and the potential long-term impacts on transformative scientific discoveries.
Study details revived debate over GLP-1 impact on devices
Recent data from a clinical trial has reignited discussions about the impact of a weight loss drug, Wegovy, on the demand for medical devices and procedures. The study showed a 20% reduction in the risk of heart attack, stroke or cardiovascular death in overweight and obese patients with heart disease, compared to a placebo. However, the results were inconclusive regarding cardiovascular death alone. This has led to mixed reactions regarding the implications for heart device makers. Additionally, the study indicated that the drug significantly lowered the risk of pre-diabetic patients developing elevated blood sugar levels, which could influence the market for insulin pumps and continuous glucose monitors. Despite concerns, some analysts believe that the drug and glucose monitoring devices are complementary, and the overall impact on metabolic health will be positive. According to Medtech Dive, the interest in weight loss drugs has also affected the growth of bariatric procedures, with expectations that some patients may delay surgery to try these drugs first.
Note, we will pause publication of our “5 things” due to the holiday next week and will resume the following week.
For more insights in life sciences, check out RSM’s industry outlook.
