Although approvals were down year-on-year, December saw a rash
of drug registrations, which included innovative products like MACI
(autologous chondrocytes on an implantable artificial matrix), the
antisense molecule Spinraza (nusinersen), and Zinplava, a fully human
monoclonal antibody that targets Clostridium difficile toxin B. However,
complete response letters predominated more than in previous quarters,
with setbacks for Cempra’s solithera and Regeneron’s sarilumab.
Decisions on several biosimilars are on the horizon.
NATURE BIOTECHNOLOGY VOLUME 35 NUMBER 2 FEBRUARY 2017
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