Latin American and MENA markets have long faced the challenge of balancing constrained public budgets with rising demand for newer therapies. In 2025, governments in these regions took concrete steps to modernize pricing rules, raise evidence expectations, expand partnership models,…
Across Europe, 2025 accelerated a shift from sequential regulatory and access steps to more connected process through the Joint Clinical Assessment. Regulatory approvals, and clinical portion of HTA evaluation are now more tightly linked, which has the potential to bring…
Globally, 2025 marked a shift from debating drug pricing policy to implementing it. Pricing pressure intensified, evidence expectations rose, and long-standing access models began to change amid political and fiscal realities. In Trinity’s webinar “Around the World in Market Access…
President Trump signed the “One Big Beautiful Bill Act” (OBBBA) into law on July 4, 2025. The OBBBA is projected to reduce federal health spending by an estimated $900 billion[1] over the next decade. Central to the legislation is…
March 2025 marked a pivotal moment for pharmaceutical and biotech companies operating in the European Union (EU) as the first two molecules began to proceed through the Joint Clinical Assessment (JCA) process. At a recent seminar hosted by…
Germany's Medical Research Act (Medizinforschungsgesetz or MFG), which came into force on October 30, 2024, is a major legislative reform aimed at strengthening Germany’s position as an attractive environment for medical innovation and pharmaceutical development. The act provides for…
The first 100 days of President Trump’s return to the White House have been anything but ordinary. With a true “Flood the Zone” strategy, there has been a flurry of executive orders, leadership reshuffles, and a re-assertion of executive power,…
Health equity continues to be a hot topic in the life sciences industry. ISPOR EU sessions addressed several key questions surrounding the impact of health equity on HTA decision-making, the methodologies that should be employed, and the opportunities…
On January 20, 2025, the Centers for Medicare & Medicaid Services (CMS) announced the set of fifteen drugs targeted for the second round of Maximum Fair Price (MFP) “negotiations” under the Inflation Reduction Act (IRA). With the outcomes…
Cell and gene therapies (CGTs) have ushered in a new era of medicine, offering patients transformative, even potentially curative solutions, with a single treatment. Despite the clinical promise, barriers to patient access remain given administration complexity, gaps in patient…