Market Access

Sponsors of three drugs that are in the final stages of the EU regulatory review cycle are due to make the case for marketing approval before the European Medicines Agency.

Regenxbio is riding a wave these days, with all three of its clinical-stage programs set to reach critical milestones this year and recent positive news on its DMD gene therapy, just as Sarepta suffered a setback with a death related to its DMD treatment. In Vivo spoke with CEO Curran Simpson about the company’s plans and strategic decisions.

An initiative run by health technology appraisal (HTA) bodies in the US, Canada and England is looking at how non-traditional treatment benefits, such as the value of hope and scientific spillover, can inform appraisals and understanding of a product’s value.

The Member State Coordination Group on HTA has also resolved to improve information sharing with drug developers to improve resource planning for EU-level joint clinical assessments.

An ordinance came into effect on 8 March to ensure that joint clinical assessments can be incorporated into the German pricing and reimbursement system.

Rentschler Biopharma CEO Benedikt von Braunmühl tells In Vivo about the CDMO's strategic decision to exit the cell and gene therapy manufacturing space.

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.

The first reimbursement reports published by the Spanish health ministry to improve transparency focus on CSL’s Hemgenix, BMS’ Camzyos and Pfizer’s Velsipity.

A new methodology for measuring pharmaceutical company carbon footprints could lead to a single standard for producing these calculations that is applicable to all medicines sold in France, said the industry association, Leem. However, it warned that there remains uncertainty about how the methodology will work in practice.

In a video interview, Wockhardt chairman Habil Khorakiwala talks about global commercial and manufacturing plans for superbug-busting novel antibiotics and developments such as proposed US tariffs and the Windsor framework that could impact its markets.