uniQure wins a BTD for he­mo­phil­ia B ther­a­py; Al­ler­gan scores sN­DA for Avy­caz

• The Dutch biotech uniQure has picked up a break­through drug des­ig­na­tion from the FDA for AMT-060, its gene ther­a­py for he­mo­phil­ia B. Spark Ther­a­peu­tics and its part­ners at Pfiz­er have a ri­val gene ther­a­py in the clin­ic for he­mo­phil­ia B, along with Sang­amo and Di­men­sion. Shire, though, re­cent­ly shelved its pro­gram, ac­quired in the Bax­al­ta buy­out.

• The FDA has ap­proved Al­ler­gan’s sN­DA to up­date the la­bel for Avy­caz (cef­tazidime and avibac­tam) with clin­i­cal da­ta from two Phase III tri­als sup­port­ing the in­di­ca­tion to treat pa­tients with com­pli­cat­ed uri­nary tract in­fec­tions, in­clud­ing pyelonephri­tis, caused by des­ig­nat­ed sus­cep­ti­ble Gram-neg­a­tive mi­croor­gan­isms.

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