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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.
Endo subsidiary Par Sterile Products will expand its Rochester, Michigan facility to begin the fill-finish manufacturing of both mRNA and adenovirus vaccines. Around three-quarters of the project’s expected $120m total costs are being funded by the US government as part of larger efforts to boost the country’s domestic supply of essential medicines.
Sawai’s Q2 results mirrored those of Q1, with a strong performance in Japan but a weak one in the US. The firm is continuing to focus on establishing new production facilities in both territories.
FDA officials outline the impact of using alternative tools to assess manufacturing facilities amid COVID-19 and share key experiences around these, including with remote interactive evaluations.
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.
Concerns raised around defining ICH Q12 “established conditions” for post-approval changes and potential role of prior knowledge for legacy products discussed in the context of generic drug applications; likely residual lack of harmonization explored.
Stating the importance of the US sterile injectables market for Fresenius Kabi, Matt Kuhn, senior director of external communications, talks to Generics Bulletin about the company’s plans to build one of the largest sterile injectable manufacturing networks in America. Meanwhile Ali Ahmed, senior vice president of biosimilars at Fresenius Kabi in the US, talks about supply reliability in biosimilars.
Lannett is once again taking the axe to its operations in order to tighten its focus and save on costs, including the planned divestment of its liquids generics manufacturing facility in Carmel, New York.
Fresenius Kabi is continuing to suffer from the longstanding effects of the US FDA backlog for onsite inspection reviews amid the coronavirus pandemic. Management discussed Kabi’s latest prospects on its proposed pegfilgrastim biosimilar, as well as adalimumab and tocilizumab.
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