Protocols

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.

• Lexington, MA-based Agenus named Jean-Marie Cuillerot Chief Medical Officer. Dr. Cuillerot initially joined Agenus in 2016 as the Vice President and Global Head of Clinical Development.


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