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U.S. Orphan Drug roundup

Published 03/14/2018, 10:07 AM
© Reuters.  U.S. Orphan Drug roundup
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  • The FDA has designated the following as Orphan Drugs:
  • Tetra Bio-Pharma's (OTCQB:TBPMF +11.2%) PPP001 (delta-9-tetrahydrocannabinol 9.5% and cannabidiol 2.5%) for the treatment of complex regional pain syndrome.
  • GlaxoSmithKline's (GSK +0.7%) GSK2696274 (autologous CD34+ cells) for the treatment of metachromatic leukodystrophy.
  • Trillium Therapeutics' (TRIL +1.3%) 1-118-signal protein alpha (human) fusion protein with IgG1 Fc (appears to be TTI-621) for the treatment of cutaneous T-cell lymphoma.
  • Incyte's (INCY +1%) INCB054828 (pemigatinib) for the treatment of cholangiocarcinoma.
  • Celgene's (CELG +1.5%) CC-122 [3-(5-amino-2-methyl-4-oxoquinazolin-3(4H)-yl) piperidine-2,6-dione hydrochloride] for follicular lymphoma.
  • Among the benefits of Orphan Drug status in the U.S. is a seven-year period of market exclusivity for the indication, if approved.
  • Now read: Incyte: This ROTY Contender Is On Sale


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