In wake of a tri­al dis­as­ter, Seat­tle Ge­net­ics files sBLA; Egalet takes a dive on a CRL

→ One day af­ter scrap­ping a Phase III study, Seat­tle Ge­net­ics filed an sBLA for Ad­cetris to treat pa­tients with cu­ta­neous T-cell lym­phoma. The sBLA is based on pos­i­tive re­sults from a Phase III study pub­lished this month in The Lancet.

→ Shares of Egalet dropped 20% on the news that it re­ceived a com­plete re­sponse let­ter from the FDA re­quest­ing in­for­ma­tion about its pri­or ap­proval sup­ple­ment of Ox­ay­do tablets. The drug was de­signed to re­duce the risk of abuse but there is cur­rent­ly no ev­i­dence that the for­mu­la­tion has less abuse po­ten­tial than im­me­di­ate-re­lease oxy­codone.

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