Each week we highlight five things affecting the life sciences industry. Here’s the latest.
How the Trump administration could affect the life sciences industry
- The incoming Trump administration may promote increased mergers and acquisitions activity in the biopharma sector due to a less restrictive Federal Trade Commission approach, while addressing leftover policies like Medicare drug price negotiations and the Inflation Reduction Act, according to BioSpace.
- Robert F. Kennedy Jr.’s potential appointment as secretary of health and human services could affect vaccine sales and development by challenging vaccine approvals and industry ties to regulatory agencies, while the appointment of Marty Makary as U.S. Food and Drug Administration head is seen as more conventional and reassuring to the industry.
Biden administration proposes Medicare and Medicaid coverage of weight loss drugs
- According to NBC News, the Biden administration has proposed expanding Medicare and Medicaid coverage for weight loss drugs by reclassifying them as treatments for chronic diseases, potentially reducing costs for millions of Americans but raising concerns about long-term affordability and drug pricing.
- Critics worry that the high cost of these drugs could strain the health care system, while advocates argue expanded access may lower overall healthcare expenses by preventing obesity-related complications.
FDA issues guidance related to AI-enabled devices
- The FDA has issued final guidance on pre-determined change control plans (PCCPs) for artificial intelligence-enabled medical devices, allowing manufacturers to propose modifications to improve device performance post-market without requiring new submissions, provided the changes align with an approved PCCP and maintain safety and effectiveness, according to MedTech Dive.
- PCCPs enable iterative updates, such as retraining AI models to enhance sensitivity or reduce errors. This framework aims to support innovation while ensuring oversight for AI-enabled devices.
Large pharmaceutical companies race toward an oral GLP-1 drug
- The pharmaceutical industry is poised for a major shift with the development of oral GLP-1 drugs for obesity, offering a convenient alternative to injectables, which could significantly expand market accessibility and reduce associated costs.
- Major US and European pharmaceutical companies are spearheading this innovation; however, some less known firms are beginning to enter the market, per Fierce Pharma.
Major growth expected in the life sciences services sector through 2030
- Fierce Pharma reports that the global contract research organization and clinical trial site network markets are projected to grow significantly from 2025 to 2030.
- The increase is driven by increased outsourcing and research and development spending, with the Asia-Pacific region, particularly China, leading the growth due to rising local activity and increased trial outsourcing.
For more insights in life sciences, check out RSM’s industry outlook.
