Below we highlight how the European Medicines Agency (EMA) is reshaping the biosimilar approval framework by prioritising advanced analytical characterisation over traditional comparative efficacy studies. A recently finalized reflection paper outlines a science-based, tailored clinical develo...

In this update we highlight the persistent shortcomings in outcome transparency in Netherland's healthcare system. The 2026 baseline measurement report published by Zorginstituut Nederland and Patiëntenfederatie Nederland shows that national ambitions for transparency of care outcomes in medical ...

Immunotherapy ovarian cancer treatment has taken a major step forward in Europe. The European Commission has approved KEYTRUDA (pembrolizumab) in combination with paclitaxel, with or without bevacizumab, for adults with PD-L1 CPS ≥1 platinum-resistant recurrent ovarian, fallopian tube, or primary...

Immunotherapy hepatocellular carcinoma treatment has taken a significant step forward with positive high-level results from the EMERALD-3 Phase III trial. The addition of dual immunotherapy using AstraZeneca’s STRIDE regimen (Single Tremelimumab Regular Interval Durvalumab) together with lenvatin...

Reimbursement Bladder Cancer advances with the assignment of a permanent HCPCS J-code for INLEXZO™ (gemcitabine intravesical system), effective April 1, 2026. This standardized billing code simplifies reimbursement bladder cancer treatment for adult patients with BCG-unresponsive non-muscle invas...

President Donald J. Trump has imposed tariffs on patented pharmaceutical products and their ingredients, using tariffs pharmaceutical manufacturing policy to protect national security and strengthen U.S. supply chains. The move applies a baseline 100% tariff on patented pharmaceuticals, with lowe...