5 things to know in life sciences: Week of March 4, 2024 

REAL ECONOMY BLOG | March 08, 2024

Authored by RSM US LLP

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

Biden administration receives counteroffers from drug companies

• 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.

Promising outcomes for weekly HIV treatment

• 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.

Navigating the future of laboratory-developed test regulation

• 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.

Innovative approach to clinical trial enrollment explored

• 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’s revolutionary metabolic contract research organization service

• 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.