When the European Parliament adopted its position on the EU pharmaceutical package on 10 April 2024, it rejected most of its rapporteur's proposals to further reduce orphan medicine exclusivity (OME).
European Parliament Has Missed The Chance to Boost Orphan Drug Development
The European Parliament could have helped to stimulate R&D into new drugs for rare diseases if it had not stuck so closely to the European Commission’s original proposals on orphan exclusivity periods, say Baker McKenzie lawyers Els Janssens, Julia Gillert, Magda Tovar and Olha Sviatenka.
More from Europe
• By
In a historic move for Africa, five products have been backed for approval via a pilot that tested a continental listing process.
• By
Pharmaceutical companies are being encouraged to reach out to NICE in relation to its HTA Innovation Lab, which provides a sandbox environment in which the health technology assessment body can test new methods of evaluating “innovative and disruptive” therapies.
• By
The weight management drug, Mysimba, continues to demonstrate a positive benefit-risk balance but the data available are not sufficient to fully determine the cardiovascular safety beyond 12 months. Meanwhile, Currax this month announced the publication of a peer-reviewed study of Mysimba that followed patients for over 4.7 years and found no evidence of excess cardiovascular risk.
• By
Health technology assessment body NICE said it has taken on feedback about the implications of allowing higher cost-effectiveness thresholds for some medicines after senior health economists offered diverging views on its methods.
More from Geography
• By
In a historic move for Africa, five products have been backed for approval via a pilot that tested a continental listing process.
• By
CMED, which sets medicine prices in Brazil, has published the maximum price adjustment index for 2025.
• By
Amid ongoing generic drug supply problems, Japan's government is to set up a new fund to support corporate investments geared towards manufacturing and consolidation.