Take­da re­ceives ad­di­tion­al FDA ap­proval for GI drug; Can­cer Re­search UK to test gem­c­itabine for ad­vanced pan­cre­at­ic can­cer

→ The FDA has giv­en the green light to Take­da to ex­tend­ed the in­di­ca­tion of its drug Gat­tex (tedug­lu­tide) for in­jec­tion to pe­di­atric pa­tients 1 year of age and old­er with short bow­el syn­drome (SBS) who need ad­di­tion­al nu­tri­tion or flu­ids from in­tra­venous (IV) feed­ing (par­enter­al sup­port).

→ More than a decade af­ter the FDA first ap­proved Frag­min to treat blood clots in adults, Pfiz­er has won an OK to ex­tend its use in pe­di­atric pa­tients as young as one month old. There’d been no FDA-ap­proved ther­a­pies to treat ve­nous throm­boem­bolism in this pop­u­la­tion, Richard Paz­dur said in a state­ment, who are of­ten suf­fer­ing from a se­ri­ous un­der­ly­ing con­di­tion such as can­cer and con­gen­i­tal heart dis­ease. The ap­proval was based on a sin­gle tri­al with 38 pa­tients, in which “21 pa­tients achieved res­o­lu­tion of the qual­i­fy­ing VTE, sev­en pa­tients showed re­gres­sion, two pa­tients showed no change, no pa­tients ex­pe­ri­enced pro­gres­sion of the VTE and one pa­tient ex­pe­ri­enced re­cur­rence of VTE.”

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