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Alkermes PLC

www.alkermes.com

Latest From Alkermes PLC

Synthorx Throws THOR-707 Into Competitive IL-2 Space With HAMMER, Its First-Ever Clinical Trial

Emerging Company Profile: This is the first human study for lead product candidate THOR-707 and for the company's Expanded Genetic Alphabet platform, starting with a recombinant IL-2 that's being tested in solid tumors.

Business Strategies ImmunoOncology

Intra-Cellular's Lumateperone Brings Mixed Results In Bipolar Depression

Firm will discuss Phase III data with the US FDA, calling results from a successful Phase III monotherapy study robust despite second Phase III study's failure. Lumateperone is under review for schizophrenia, with a 27 September action date.

Clinical Trials Drug Approval Standards

CDER Midyear Report: Sponsors Struggle With Drop In Novel Approval Rate

CDER has approved only 13 novel products in the first half of 2019 while issuing at least seven such CRLs during that timeframe. The sparse approval landscape more so resembles that of 2016 compared with the banner years of 2017 and 2018.

Approvals Complete Response Letters

Big Brands Poised To Lose US Marketing Exclusivity In 2019

With the first generic versions of blockbuster brands like Advair, Lyrica, Restasis and Sensipar and the first biosimilars of Herceptin, Avastin and Rituxan expected to launch in the US, 2019 could be a notable year for generics and biosimilars.

Generic Drugs Market Intelligence
See All

Company Information

  • Industry
  • Biotechnology
    • Large Molecule
    • Nanotechnology, Chips, etc.
  • Pharmaceuticals
    • Drug Delivery
      • Controlled Release
      • Macromolecule
      • Pulmonary
  • Therapeutic Areas
  • Cancer
  • Musculoskeletal & Connective Tissue Disorders
  • Neurology, Nervous System
  • Alias(es)
  • Alkermes Inc.
  • Ownership
  • Public
  • Headquarters
  • Worldwide
    • Europe
      • Western Europe
        • Ireland
  • Parent & Subsidiaries
  • Alkermes PLC
  • Senior Management
  • Richard F Pops, Chmn. & CEO
    James M Frates, SVP, CFO
    Blair C Jackson, SVP, Bus. Dev.
    Mark Stejbach, SVP, Chief Commercial Officer
    James Robinson, Pres. & COO
  • Contact Info
  • Alkermes PLC
    Phone: 1 772 8000
    1 Burlington Rd.
    Connaught House
    Dublin 4, MA
    Ireland
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