Search
The EU HTA Regulation Is Reshaping How Clinical Evidence Supports Market Access Across Europe
On 30 April 2026, a milestone quietly passed that will redefine how innovative medicines reach patients across the European Union. The HTA Coordination Group (HTACG) approved the very first Joint Clinical Assessment (JCA) report in history — covering tovorafenib (Ojemda®), Ipsen's treatment for paediatric low-grade malignant glioma. Completed well within the 30-day timeline from marketing authorisation, it marked the first real-world product of a regulatory and market access
Jul 2814 min read
10 Clinical Trials to Watch in H2 2026: From Lung Cancer Immunotherapy to Personalised Cancer Vaccines — A Regulatory Affairs Briefing
The most closely watched clinical trials to watch in H2 2026 span lung cancer immunotherapy, personalised mRNA cancer vaccines, obesity drugs, rare neuromuscular disease and novel anticoagulants, according to industry tracking from BioPharma Dive. These trials affect oncologists, biotech investors, sponsors and regulatory affairs teams preparing dossiers across the FDA, EMA and MHRA. Readouts expected between July and December 2026 will shape marketing authorisation strategy,
Jul 1012 min read