FDA starts the pri­or­i­ty re­view clock for Sym­bio­mix; Cor­ner­stone gets a green light on piv­otal stud­ies

→ The FDA ac­cept­ed Sym­bio­mix’s NDA for Solosec (sec­nida­zole oral gran­ules), an an­tibi­ot­ic de­signed to treat bac­te­r­i­al vagi­nosis, and stamped it with a pri­or­i­ty re­view sta­tus that will cut the de­ci­sion process down to six months. The PDU­FA date is Sep­tem­ber 17.

→ Cran­bury, NJ-based Cor­ner­stone Phar­ma­ceu­ti­cals got a reg­u­la­to­ry green light to launch piv­otal stud­ies of their lead drug, CPI-613, in pa­tients with acute myeloid leukemia (AML) and pan­cre­at­ic can­cer. Said Cor­ner­stone COO San­jeev Luther: “The FDA has pro­vid­ed valu­able feed­back to in­form a de­sign that will en­hance the ro­bust­ness of our tri­als. This would al­low the Agency to as­sess them as reg­is­tra­tional tri­als.”

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