ValuePills

In Italy, the Balduzzi Law (Law 189/2012, Article 12, paragraph 3) allows pharmaceutical companies to submit P&R Dossiers for orphan drugs just after the publication of a positive CHMP opinion, without the need to wait for the EC decision; clearly, the aim of such provision is the acceleration of time to reimbursement for orphan drugs

Following his speech at the 19th SIARV Educational Course, titled “Beyond the horizon:Pharmaceutical innovation between geopolitical storms and new cures”, the SIARV Executive Board decided to interview Renato Dellamano to explore some of the issues that emerged. The presentation provided a strategic analysis of the deep changes that are redefining the global landscape of market

On February 23, 2026, BioMarin announced the withdrawal from the EU market of Roctavian (valoctocogene roxaparvovec) a gene therapy for the treatment of hemophilia A (source:  https://www.biomarin.com/news/company-statements/biomarin-voluntarily-withdraws-roctavian-from-the-market/. The news came after the Company was unable to find a buyer for the product, following the decision to offload Roctavian from the Company’s portfolio announced in October 2025. The

Renato Dellamano, President and Founder of ValueVector, recently presented a speech at the Training Course organized by the Italian Society of Regulatory Affairs, Market Access and Pharmacovigilance (SIARV) in Rome on May 27-28, 2026 – https://www.siarv.it/giornate-di-studio-e-aggiornamento-dedicato-alle-attivita-regolatorie-di-accesso-e-di-farmacovigilanza-19-corso-didattico/ The title of his speech was: “Beyond the horizon: Pharmaceutical innovation between geopolitical storms and new cures’’. Key topics