Man­u­fac­tur­ing tweaks to sub­cu­ta­neous Tecen­triq de­lay Roche's US launch, CMC process­es to be up­dat­ed by year’s end

Roche in­formed its drug de­liv­ery tech part­ner Halozyme Ther­a­peu­tics that the US launch of the sub­cu­ta­neous ver­sion of Tecen­triq will be de­layed to next year due to man­u­fac­tur­ing changes. The US de­ci­sion was ini­tial­ly ex­pect­ed on Sept. 15. Halozyme is­sued the se­cu­ri­ties fil­ing on Wednes­day.

“The launch of our sub­cu­ta­neous for­mu­la­tion of Tecen­triq in the US will be de­layed, as we are mak­ing up­dates to our Chem­istry, Man­u­fac­tur­ing and Con­trols (CMC) process­es in line with evolved FDA re­quire­ments,” a Roche spokesper­son told End­points News. 

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