RWE Demonstrates Significant Four-Year MACE Reduction Repatha (Evolocumab), Amgen’s PCSK9 inhibitor, has once again demonstrated its cardiovascular impact, this time in a real-world population exceeding 110,000 patients. New findings presented at the American Heart Association Scientific Sessions 2025 show that the therapy delivers sustained, long-term reductions in major adverse cardiovascular events (MACE) for patients with … Read more
Broader 2026 Coverage Enhances Economics Across Multiple Care Settings A sweeping set of CMS and Medicaid reimbursement decisions is reshaping 2026 access across neuromodulation, electrophysiology, advanced wound reconstruction, diagnostic testing, and regenerative biologics. From APC assignments and ASC approvals to national pricing and expanded Medicaid coverage, these updates strengthen commercial readiness for emerging technologies while … Read more
CMS has issued the CY 2026 ESRD PPS final rule, introducing a higher base rate, new geographic adjustments, revised outlier policies, and changes to the ESRD Quality Incentive Program.
Sotatercept Nears Public Coverage After National Pricing Deal Merck Canada has completed national pricing negotiations with the pan-Canadian Pharmaceutical Alliance (pCPA) for WINREVAIR (sotatercept), marking a significant milestone in the therapy’s journey toward broad public reimbursement across Canada. The agreement, announced on November 20, 2025, positions the first-in-class activin signaling inhibitor one step closer to … Read more
What the New Medicare 2026 Rates Mean for Access and Adoption The U.S. Centers for Medicare & Medicaid Services (CMS) has delivered a rare cluster of reimbursement decisions that collectively mark one of the most significant access-defining weeks of 2025. Spanning neuromodulation, molecular diagnostics, AI imaging, autoimmune disease therapy, and oncology support care, the rulings … Read more
Philips Debuts AI DeviceGuide to Enhance Real-Time Navigation in Heart Valve Repair
Novo Nordisk has introduced a $199 introductory price for Wegovy and Ozempic starter doses, alongside a permanent drop in monthly self-pay costs to $349.
ABL Bio has signed a major license and research collaboration with Eli Lilly worth up to $2.602 billion, granting access to its Grabody bispecific platform.
Eli Lilly has signed back-to-back collaborations with SanegeneBio and MeiraGTx, advancing its genetic medicine portfolio across RNA interference and ophthalmic gene therapy. Together, the agreements deepen Lilly’s position in next-generation RNA- and DNA-based therapeutics.
Scientists and staff walk outside the U.S. Food and Drug Administration headquarters, representing the agency’s growing focus on regulatory innovation and public health priorities. (AI-generated for editorial illustration purposes.) FDA expands National Priority Voucher pilot with six new awardees, bringing total to 15 therapies The U.S. Food and Drug Administration (FDA) has announced a significant … Read more