EU Avastin Court Ruling Deals Yet Another Blow To Novartis
Executive Summary
In the latest in a string of knockbacks for both Novartis and Roche, the EU’s highest court has said that the Italian authorities are within their rights to reimburse Roche’s Avastin for wet AMD, even though it is not approved for that indication.
You may also be interested in...
UK Court Ruling Ends Novartis/Bayer Crusade Against Avastin In AMD
AMD patients in the UK can legitimately be given compounded bevacizumab (Roche’s Avastin) after the appeals court said NHS trusts could offer a drug off-label for economic reasons where there were no safety or efficacy concerns.
Italy’s Little-Known Early Access Program
Italy’s early access system is mainly used for unapproved uses of authorized medicines, and is driven by clinicians, rather than companies.
How Drug Preparations Undermine Europe’s Regulatory System
Genevieve Michaux and Luca Salernitano examine the complexities and concerns surrounding the flourishing practice of preparing medicines for patients by pharmacies and hospitals in the EU. They say it undermines the very essence of the EU drug evaluation system and the regimes adopted to incentivize the development of medicinal products for rare diseases and pediatric patients.