Each week we highlight five things affecting the life sciences industry. Here’s the latest.
FDA shifts away from long‑standing “two pivotal trials” expectation
- In an article published in The New England Journal of Medicine, the U.S. Food and Drug Administration announced it is shifting toward allowing approval based on a single, well designed pivotal trial, supplemented by confirmatory or real-world evidence, rather than the longstanding expectation of two independent trials—aiming to speed patient access without abandoning evidentiary rigor.
- The FDA argues that this approach reflects modern trial capabilities and unmet medical needs, but emphasizes that strong trial design, clinically meaningful endpoints and post approval surveillance are critical to prevent erosion of regulatory standards.
Federal moratorium targets medical equipment fraud
- Federal health officials announced a new moratorium on certain durable medical equipment, prosthetics, orthotics and supplies providers in high-risk areas to curb fraudulent billing and protect Medicare and Medicaid funds.
- According to HME Business, the crackdown expands enforcement efforts by suspending new supplier enrollments in designated regions while authorities intensify oversight and fraud prevention measures.
Push to codify international drug pricing policy
- As reported in BioSpace, President Trump urged Congress during the State of the Union address to codify a most-favored-nation drug pricing model aimed at lowering U.S. prescription costs by tying them to prices paid in other countries.
- The proposal would formalize the policy through legislation, framing it as a major step toward reducing federal health care spending and addressing long-standing pricing disparities.
China accelerates biopharma investment strategy
- China is intensifying financial support for its biopharma sector through expanded investment initiatives aimed at boosting innovation, domestic production and global competitiveness.
- According to PharmaVoice, the strategy includes increased funding channels and policy backing to strengthen research capabilities and attract capital amid global market pressures.
FDA weighs oversight of rare disease gene therapies
- Federal regulators released details of a new policy aimed at getting cutting-edge treatments to patients suffering from rare diseases.
- According to NPR, the new protocols would allow the agency to approve treatments that have evidence of a “plausible mechanism” for how the treatment would work.
For more insights in life sciences, check out RSM’s industry outlook.
