Thursday, February 17, 2022 Daily Archives

eTheRNA inks mRNA partnership with Merck KGaA

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The collaboration will study the application of eTheRNA’s mRNA and LNP-delivery platforms to disease areas picked by Germany’s Merck. The research collaboration will target messenger RNA (mRNA) therapeutics using eTheRNA’s mRNA and lipid nano particle (LNP) technologies in various model systems. If successful, mRNA encoding antigens will be nominated by Merck KGaA relevant for human diseases. “eTheRNA has developed a platform of differentiated mRNA capabilities clinically proven to modulating the dendritic cell-T-cell interactions that are at the heart of all…

February 17, 2022

EUAs for rare disease advanced therapies? Not likely, says FDA

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The FDA has dismissed using special emergency authorization powers for rare disease advanced therapeutics but does hope to significantly speed up its feedback to sponsors. The US Food and Drug Administration’s (FDA) Emergency Use Authorization (EUA) authority allows the use of unapproved medical products to be used in an emergency to diagnose, treat, or prevent serious or life-threatening diseases or conditions caused by chemical, biological, radiological, and nuclear (CBRN) threats when certain criteria are met. Most recently, EUA powers have…

February 17, 2022

Takeda contracts Resilience to bolster plasma network

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The deal sees CDMO Resilience support the development and manufacture of Takeda’s plasma-derived medicines portfolio from its site in Ontario, Canada. Reporting on its third quarter FY2022 at the beginning of this month, Takeda posted revenues of 363.2 billion yen ($3.2 billion) from its plasma-derived therapy (PDT) immunology division, up 10% year-on-year and driven by immunoglobulin and albumin sales. The firm also told stakeholders it is undergoing a strategy to increase plasma supply and manufacturing capacity by more than 65%…

February 17, 2022