Pakistan recalls altered dose of Avastin; FDA rejects Botanix gel

Plus, MC2’s new li­cens­ing deal with Re­gran­ion and AM-Phar­ma an­nounces a new CEO and work­force cuts.

Pak­istan re­calls al­tered Avastin

Pak­istan is pulling a dose of Avastin from the mar­ket due to in­ci­dents of dam­aged vi­sion in di­a­bet­ic pa­tients who re­ceived off-la­bel “al­tered” or “di­lut­ed” ver­sions of the in­jec­tion. The Drug Reg­u­la­to­ry Au­thor­i­ty of Pak­istan cit­ed Ge­nius Ad­vanced Phar­ma­ceu­ti­cal Ser­vices, say­ing the is­sues are like­ly due to il­le­gal sales of the drug un­der non-ster­ile con­di­tions. Roche’s Avastin is ap­proved to treat col­orec­tal and metasta­t­ic car­ci­no­mas in Pak­istan. It’s not au­tho­rized for use in di­a­bet­ic pa­tients or for oth­er oph­thalmic con­di­tions.

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