Clinical Trials

With an ambitious goal to file a biosimilar to the world-renowned Botox brand via the US FDA’s 351(k) regulatory pathway, AEON Biopharma has revealed the latest steps in its plan.

Merck & Co., which already has an oral PCSK9 inhibitor in Phase III, licensed Hengrui’s Lipoprotein(a)-lowering small molecule HRS-5346 outside of Greater China for $200m up front.

The FOCUS study met its primary and key secondary endpoints, but lack of statistical significance on the higher dose and a crowded market raised questions.

Amgen’s AI model to predict proteins in the “bright Goldilocks zone of viscosity” with over 80% accuracy minus a wet lab experiment holds immense potential, VP Research Haldar said at an event as he spoke about a “hinge moment” for AI in pharma

In Vivo spoke with Tran Le and Sohit Gatiganti, co-founders of Grove AI and developers of Grace, a voice-based AI agent to streamline clinical trial processes.

Vertex has the first-in-class NaV1.8 inhibitor for acute pain, Journavx, but Latigo plans to bring forward multiple best-in-class options for acute and chronic pain against NaV1.8 and other targets.

A new study by AcuityMD, presented at AAOS 2025, highlights the continued shift of spinal surgeries to the outpatient setting, with state-by-state variability in ASC adoption. While hospitals still dominate spinal procedures, advancements in minimally invasive techniques and medical technologies are major drivers of spinal surgeries in the ASC setting.

Trial sponsors in Germany should start preparing negotiation strategies to tackle difficult discussions with trial sites over standardized clauses.

A new Innovative Health Initiative project will see the German health technology appraisal (HTA) body, IQWiG, work towards ensuring evidence generated in clinical studies meets the needs of HTA bodies and regulators.

Most fees and fee uplifts proposed by the UK MHRA to begin in April 2025 will be implemented on schedule. A general 8.85% increase will be applied to all statutory fees, but the new medical devices registration fee is subject to ongoing review and/or alternative options.