Is­rael's VBL Ther­a­peu­tics hit with CMC de­lays in ovar­i­an can­cer study; No­vo Hold­ings buys out di­ag­nos­tics play­er BBI

VBL Ther­a­peu­tics has hit a road­block in its Phase III study for plat­inum-re­sis­tant ovar­i­an can­cer.

Batch­es of the VB-111 com­pound be­ing eval­u­at­ed in the study are still be­ing re­viewed by the FDA’s CMC group, the com­pa­ny an­nounced Tues­day, with reg­u­la­tors try­ing to com­pare VB-111 man­u­fac­tur­ing be­tween dif­fer­ent sites. As a re­sult, sup­ply will be lim­it­ed and VBL is paus­ing en­roll­ment of the 400-pa­tient study un­til the batch­es can be cleared.

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