As­traZeneca gets a thumbs-up for ZS-9 in Eu­rope; Toca­gen wins a BTD for brain can­cer drug

• As­traZeneca has won a rec­om­men­da­tion for its close­ly-watched hy­per­kalemia drug ZS-9 from the EMA’s Com­mit­tee for Med­i­c­i­nal Prod­ucts for Hu­man Use. As­traZeneca bought the drug from ZS Phar­ma in a $2.7 bil­lion deal, but was hit with a CRL from the FDA due to man­u­fac­tur­ing con­cerns. A for­mal Eu­ro­pean ap­proval for the drug should fol­low in a few months.

• San Diego-based Toca­gen has won the FDA’s break­through ther­a­py des­ig­na­tion, giv­ing them quick ac­cess to reg­u­la­tors as they ad­vance To­ca 511 and To­ca FC for pa­tients with re­cur­rent high grade glioma. “Re­ceiv­ing Break­through Ther­a­py Des­ig­na­tion from the FDA for re­cur­rent HGG, the first time it has been grant­ed for this type of brain can­cer, high­lights the ur­gent need for new treat­ment op­tions for this dead­ly dis­ease,” said Mar­ty Du­vall, chief ex­ec­u­tive of­fi­cer of Toca­gen. “Based on the en­cour­ag­ing safe­ty and ef­fi­ca­cy da­ta we have seen to date, ad­vanc­ing the de­vel­op­ment of To­ca 511 & To­ca FC con­tin­ues to be our team’s top pri­or­i­ty.”

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