DARWIN EU and the evolution of real-world data regulation in Europe
By Fisentzos Stylianou, PhD Contact: [email protected] One of the main healthcare challenges raised by the European Medicines Agency’s (EMA) network strategy to 2025 is the
European HTA Regulation: How will it work in practice?
By Chloe Sheppard, Associate Consultant Contact: [email protected] A major milestone in the creation of pan-European joint health technology assessment (HTA) was reached in January this
Can evidence of health inequality tilt the balance of a NICE assessment?
By Fisentzos Stylianou, PhD Contact: [email protected] In November 2021, Novartis’ Adakveo (crizanlizumab) became the first treatment for sickle cell disease (SCD) to be made available
Value-based services and Orphan Drugs: Italy says yes
By Andrea Bernardini, Senior Analyst Email: [email protected] AIFA has approved reimbursement of the orphan drug Evrysdi (risdiplam) by Roche, the first at-home oral treatment for Spinal
Winds of change blowing over Germany for Orphan Drugs
By Andrea Bernardini, Senior Analyst Email: [email protected] Intensifying pressure to implement cost savings due to COVID induced economic downturn and the current ruling coalition, seem
To 2022 and beyond: what the latest budget law in Italy means for its pharmaceutical market
By Andrea Bernardini, Senior Analyst Email: [email protected] The latest approved Budget Law for the three-year period 2022-2024 is quite extensive and covers the whole planned spending
Italy shakes up early access programmes
By Richard Wang, Senior Analyst & Andrea Bernardini, Senior Analyst Email: [email protected] [email protected] On 10th of November, the Italian Medicines Agency AIFA announced that it
Is Spain becoming a cost-effectiveness market for biopharma?
By Ciaran Cassidy, Snr Analyst Email: [email protected] On the 25th of July, the AEMPS of Spain published the first Therapeutic Positioning Report (Informe de Posicionamiento
FDA stokes controversy with Alzheimer’s drug approval – what will it mean?
By Max Rex, Consultant Email: [email protected] On Monday 7th June, the FDA approved aducanumab, the first new treatment for Alzheimer’s in 18 years. Aducanumab, manufactured