Regulatory and policy developments continue to influence the biotech sector broadly. The UK government announced plans to reduce drug and medical device approval costs by 25% over the next decade to stimulate sector growth and innovation. CMS launched a voluntary gene therapy outcomes-based access model across 33 states to facilitate Medicaid coverage for expensive therapies. Medicare contractor MolDx proposed restrictive local coverage determinations impacting biomarker testing, eliciting stock declines for CareDx. The White House’s tariff proposals for pharmaceuticals remain imminent, while NIH funding cuts have devastated biomedical research programs, prompting concern about future US leadership.