Pharmaceutical companies face intensifying regulatory and pricing challenges. President Trump issued demands to major drugmakers to reduce U.S. drug prices in line with international levels within 60 days, including Medicaid and Medicare pricing reforms and direct-to-consumer sales expansion. Concurrently, regulatory hurdles impacted Regeneron, which received multiple FDA complete response letters partly due to manufacturing issues at Catalent’s facility, delaying approval for key therapies. Moderna secured a UK appeals court win affirming its vaccine patent against Pfizer and BioNTech, providing a boost amid pricing and sales pressures. Industry leaders remain cautious, addressing tariffs and regulatory uncertainty while focusing on partnerships over M&A amid these shifting dynamics.