European Industry Urges State Aid Changes To Allow COVID Recovery
Medicines For Europe Calls For Five-Year Temporary Relief To Permit Investment
A five-year period of temporary relief from EU state aid rules should be introduced for countries willing to invest in API and medicine production, Medicines for Europe has urged, insisting that current restrictions do not allow the investment necessary to bolster the supply chain in the wake of COVID-19.
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Current EU policy discourages the domestic manufacturing of essential medicines, say Medicines for Europe and the European Fine Chemicals Group. The associations have called for “immediate, robust and ambitious” policy change to drive manufacturing back home.
As Prestige BioPharma announced plans for Phase I and Phase III trials of its PBP1502 proposed adalimumab biosimilar, as well as expected filing dates in the EU and US, the company outlined how it believes its proprietary technology will allow its Humira rival to compete aggressively on price.
The FDA has outlined how it has incorporated feedback on its GDUFA science and research priorities for FY2022 from a public workshop held earlier this year, across issues including harmonization of bioequivalence standards, nitrosamine impurities, and the use of AI to support generic drug development.