FDA lifts par­tial hold on can­cer drug af­ter In­nate re­solves man­u­fac­tur­ing is­sue

In­nate Phar­ma has smoothed over a bump on a Phase II for la­cu­tam­ab, re­sum­ing en­roll­ment in the US as the FDA lifts its par­tial hold.

The hold, which was is­sued in Jan­u­ary, came af­ter the French biotech stopped treat­ing new pa­tients fol­low­ing dis­cus­sions with reg­u­la­tors in Eu­rope. Its man­u­fac­tur­ing sub­con­trac­tor, Rentschler Fill So­lu­tions, had abrupt­ly filed for bank­rupt­cy and with­drawn a cer­tifi­cate of con­for­mi­ty on the la­cu­tam­ab batch­es they pro­duced.

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