Week of March 4, 2024

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

  • The Biden administration has received counteroffers from drug manufacturers in Medicare price negotiations under the Inflation Reduction Act, marking progress in reducing prescription costs.
  • According to the U.S. Department of Health and Human Services, these efforts are part of a larger initiative to reduce health care expenses for Medicare recipients, with significant strides already made in aiding those in rural areas through expanded subsidy eligibility and capped drug costs.
  • A Phase 2 study of a weekly HIV treatment combining Merck’s Islatravir and Gilead’s Sunlenca showed high viral suppression rates.
  • According to Fierce Biotech, the study, which compares the weekly regimen to daily doses of Gilead’s Biktarvy, reported no significant adverse events and maintained CD4+ T cell counts, indicating a potential new weekly treatment option for HIV patients.
  • The U.S. Food and Drug Administration’s final rule on laboratory-developed tests moved closer to implementation, sparking debate within the lab community about the potential impact and the missed opportunity with the VALID Act, which sought to provide a more efficient regulatory framework.
  • LabPulse reports that amid concerns over the proposed LDT rule’s impact on clinical labs, a survey reveals widespread apprehension, with a significant majority of respondents fearing the removal of tests from their offerings due to financial constraints imposed by potential FDA user fees.
  • The National Cancer Institute (NCI) introduced the Virtual Clinical Trials Office (VCTO) pilot program, leveraging remote staff to address clinical trial enrollment declines due to staffing shortages, reports Fierce Biotech.
  • Targeting six U.S. clinical trial centers, including NCI-designated cancer centers and Community Oncology Research Program consortia, the VCTO aims to improve patient recruitment in underserved and minority communities through 2027, with potential expansion based on its impact.
  • Lindus Health launched a comprehensive “all-in-one metabolic CRO” service, combining contract research, site services, and clinical trial technology to expedite and enhance metabolic disease clinical trials, per the Longview News-Journal.
  • Lindus Health is focusing on services related to research around the usage of GLP-1s, which are used to treat obesity and diabetes, but other indications are being researched.

For more insights in life sciences, check out RSM’s industry outlook.

Source link: https://realeconomy.rsmus.com/5-things-to-know-in-life-sciences-week-of-march-4-2024/ by Justin Culbertson at realeconomy.rsmus.com