GSK's Adult RSV Vaccine Arexvy Approved by EU
GSK announced that its adjuvanted recombinant respiratory syncytial virus, RSV, vaccine, Arexvy, has been approved by the European Commission, EC, for use in adults aged 18 years and older. Arexvy was the first RSV vaccine authorised in the European Economic Area for the prevention of lower respiratory tract disease caused by RSV. It was previously approved in adults aged 60 years and above, as well as in those aged 50 to 59 years who are at increased risk for RSV disease. Sanjay Gurunathan, GSK Head of Vaccines and Infectious Diseases Research and Development, said: "This approval helps protect all adults aged 18 and older in Europe against RSV, a potentially serious respiratory infection that can lead to significant illness, hospitalisation and even death, particularly for those with certain underlying health conditions. GSK is proud to expand prevention options against RSV across Europe."
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Trump Administration Launches Medicare Drug Price Negotiations
- Expansion of Drug Negotiations: The Trump administration has expanded Medicare drug price negotiations to include treatments administered in doctors' offices for conditions such as diabetes and HIV, affecting 15 drugs set to take effect in 2028, aiming to reduce out-of-pocket costs for beneficiaries.
- Spending Overview: According to the Centers for Medicare and Medicaid Services, approximately 1.8 million beneficiaries utilized these medications between 2024 and 2025, accounting for about $27 billion in spending, highlighting the significance of Medicare expenditures in drug price negotiations.
- Pharmaceutical Impact Assessment: Analysts indicate that for 14 of the drugs, only Gilead's Biktarvy significantly impacts the company's estimated 2027 global sales, representing around 8%, while other drugs' Medicare revenue exposure is limited to 0% to 3%, suggesting minimal overall revenue impact for pharmaceutical companies.
- Kaiser Settlement on Fraud: Kaiser Permanente has agreed to a historic $556 million settlement over Medicare Advantage fraud allegations, reflecting the government's stringent enforcement stance on Medicare fraud, which could have far-reaching implications for the industry.

US Expands Medicare Drug Price Negotiation Scope
- Expanded Negotiation Scope: The CMS has included Medicare Part B drugs in its price negotiation program for the first time, marking a significant expansion that is expected to increase pressure on high-cost drug pricing.
- Significant Savings Potential: CMS estimates that if the negotiated prices from the second cycle had been in effect in 2024, Medicare could have saved approximately $8.5 billion in net drug costs, translating to a 36% reduction in spending across selected drugs, thereby alleviating financial burdens on seniors and taxpayers.
- Transparency in Drug Selection: CMS released a list of 50 eligible drugs for negotiation, with 15 selected based on high spending, demonstrating the agency's commitment to transparency and fairness in drug pricing, which aims to enhance public trust.
- Future Negotiation Timeline: Negotiations with participating drug manufacturers are scheduled for 2026, with any agreed prices set to take effect on January 1, 2028, providing manufacturers ample preparation time while also bringing anticipated price adjustments for Medicare beneficiaries.









