As the Russian invasion of Ukraine enters its second week, efforts are being made across the European off-patent industry to secure the supply chain and maintain access to essential medicines for Ukraine’s 44 million citizens.
Europe's Generics Industry Takes Action To Maintain Medicines Access In Ukraine
Efforts are being made across the European off-patent community to bolster the supply chain and ensure access to medicines in Ukraine, says the generics and biosimilars industry association, Medicines for Europe. It has urged the EU to take a leading role in coordinating supplies through the new emergency response body, HERA.
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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.
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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.
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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.
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The European Medicines Agency has recommended five drugs for EU-wide approval , including Averoa’s Xoanacyl for concomitant hyperphosphatemia. Two companies have withdrawn their marketing authorization applications.
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The Brazilian medicines regulator will also offer more clarity on the requirements for radiopharmaceuticals that are exempt from registration.
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South Korea announces planned revisions to a government scheme to designate "innovative" biopharma companies amid allegations of "discrimination" against foreign firms.
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Experts say PBMs should become familiar with transparency rules and prepare to release data, although more legal wrangling could occur.