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Drug pipeline 3Q17

Drug approvals are way up through three quarters, including a number of first-in-class approvals. The first drug targeting a metabolic enzyme mutated in cancer (Celgene's mitochondrial isocitrate dehydrogenase) was approved. The approval of Novartis' highly anticipated CAR-T cancer therapy Kymriah for acute myelogenous leukemia was followed two months later by another: Gilead/Kite's Yescarta for diffuse large B-cell lymphomas. Several gene therapies attained breakthrough drug designation; the first AAV gene therapy approval for a retinal disorder looks likely before year's end.

Historic US regulatory approvals by lead indication

Notable regulatory approvals (3Q17)

Notable regulatory setbacks (3Q17)

Notable clinical trial results (3Q17)

Notable upcoming regulatory catalysts (4Q17)

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DeFrancesco, L. Drug pipeline 3Q17. Nat Biotechnol 35, 1125 (2017).

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