How Tysabri survived.
Most drugs withdrawn from the market because of serious toxicities never make it back. But Biogen Idec succeeded in getting its multiple sclerosis (MS) drug Tysabri reintroduced in less than 16 months.
Huggett
Brady
B
Nature Biotechnology, USA.
D000911:Antibodies, Monoclonal / Q000009:adverse effects* / Q000191:economics / Q000627:therapeutic use; D061067:Antibodies, Monoclonal, Humanized; D002986:Clinical Trials as Topic; D004345:Drug Industry / Q000191:economics / Q000331:legislation & jurisprudence; D006801:Humans; D007968:Leukoencephalopathy, Progressive Multifocal / Q000139:chemically induced; D008004:Licensure / Q000331:legislation & jurisprudence; D009103:Multiple Sclerosis / Q000188:drug therapy / Q000191:economics; D000069442:Natalizumab; D012308:Risk Management; D056737:Safety-Based Drug Withdrawals / Q000331:legislation & jurisprudence; D016896:Treatment Outcome; D014481:United States; D014486:United States Food and Drug Administration
D000911:Antibodies, Monoclonal; D061067:Antibodies, Monoclonal, Humanized; D000069442:Natalizumab