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Is AIFA on the verge of significant reforms?
By Andrea Bernardini, Senior Analyst Email: [email protected] Nicola Magrini, the General Director of the Italian Medicines Agency’s (AIFA) has just suggested that significant changes are on
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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
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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
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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
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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
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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
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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
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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
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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