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…
Key impacts on the market access and payer environment are beginning to unfold from policies enacted in 2023 and new policies enacted in 2024. To gather insights into the latest trends, Trinity Life Sciences conducted interviews with key stakeholders across…
Yesterday, CMS released the results of the first round of “negotiated” prices for the Inflation Reduction Act (IRA).1 The IRA is a historical landmark legislation for the pharmaceutical industry, and the results from these “negotiations” involving 10 of the top…
Trinity Life Sciences recently worked with a large global pharma company to develop a new process for creating global value dossiers (GVDs) that better met the needs of regional affiliates. Matt O'Hara, who leads Trinity's Evidence Strategy practice, shares…