Approvals were down last quarter. Vertex (Cambridge, MA, USA) got a green light for its small-molecule combination to combat cystic fibrosis; Theratechnologies (Montreal, Quebec, Canada) and Sun Pharmaceuticals (Mumbai, India) received registrations for monoclonal antibodies (mAbs) to treat HIV and psoriasis, respectively. A gene therapy suffered a clinical setback in Duchenne muscular dystrophy. Decisions await several new therapeutic modalities, including short-interfering RNA (siRNA) and ASO therapies against transthyretin-related (TTR)-hereditary amyloidosis; an antibody–drug conjugate for hairy cell leukemia, a nanobody against thrombotic thrombocytopenic purpura and the first new anti-malarial in 60 years.
Historic US regulatory approvals by drug classboxed-text
Notable regulatory approvals (1Q18)boxed-text
Notable regulatory setbacks (1Q18)boxed-text
Notable clinical trial results (1Q18)boxed-text
Notable upcoming catalysts (3Q18)boxed-text
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DeFrancesco, L. Drug pipeline: 1Q18. Nat Biotechnol 36, 386 (2018). https://doi.org/10.1038/nbt.4142
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DOI: https://doi.org/10.1038/nbt.4142