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Drug pipeline: 4Q16

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.

Historic US regulatory approvals by lead indication

Notable clinical trial results (4Q16)

Notable regulatory approvals (4Q16)

Notable regulatory setbacks (4Q16)

Notable upcoming regulatory decisions (1Q17)

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DeFrancesco, L. Drug pipeline: 4Q16. Nat Biotechnol 35, 107 (2017).

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