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Akcea Therapeutics Inc.

Division of Ionis Pharmaceuticals Inc.
www.akceatx.com

Latest From Akcea Therapeutics Inc.

2018 Complete Response Letters: Efficacy Issues Drove Most Product Rejections

US FDA issued at least seven rejections to novel products; opioid analgesic sponsors had very little success, while biosimilar developers had a so-so year.

Complete Response Letters Drug Review

Anticancers, Orphans & The First CAR-Ts: New EU Drug Approvals In 2018

New approvals in the EU were again dominated by oncology drugs in 2018, although medicines for infectious diseases were a close second. The number of orphan drugs more than doubled over the previous year, to 17. There were also some star arrivals in multiple sclerosis, genetic disorders, metabolism and migraine.

Approvals Europe

EU New Drug Approvals 2018: Anticancers, Orphans, The First CAR-Ts – And More

New drug approvals in the EU were again dominated by oncology in 2018, although medicines for infectious diseases came a close second. The number of orphan drugs more than doubled over the previous year, to 17. There were also some key new arrivals in the areas of multiple sclerosis, genetic disorders, metabolism and migraine.
Approvals Europe

42 New Substances Among 84 EU Approval Recommendations In 2018

The EMA’s CHMP recommended EU marketing authorization for a total of 84 new drugs in 2018, containing a total of 42 new active substances. They included the EU’s first two CAR-T cell therapies, Kymriah and Yescarta, which were also among the 21 orphan medicines to gain a positive opinion from the committee.
Approvals Europe
See All

Company Information

  • Industry
  • Biotechnology
    • Antisense, Oligonucleotides
  • Pharmaceuticals
  • Therapeutic Areas
  • Cardiovascular
  • Metabolic Disorders
  • Alias(es)
  • 1662524
  • Ownership
  • Public
  • Headquarters
  • Worldwide
    • North America
      • USA
  • Parent & Subsidiaries
  • Ionis Pharmaceuticals Inc.
  • Senior Management
  • Paula Soteropoulos, CEO
    Michael MacLean, CFO
    Jeffrey M Goldberg , COO
    Louis St. L O’Dea, MD, CMO
    Sarah Boyce, Pres.
  • Contact Info
  • Akcea Therapeutics Inc.
    Phone: (617) 207-0202
    55 Cambridge Parkway
    Cambridge, MA 02142
    USA
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