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AB Science

www.ab-science.com

Latest From AB Science

CHMP Readies ‘Outstanding Issues’ Lists For Products Nearing EU Review End

Baxter, Ariad, Diurnal. Kyowa Kirin and AB Science are among the companies that will shortly find out what remaining concerns the European Medicines Agency’s key advisory panel, the CHMP, has regarding products of theirs that are under review.

Europe Approvals

Helsinn And AB Science Persevere In EU Despite CHMP Setback

Helsinn and AB Science plan to conduct additional studies with their products the CHMP turned down this month, in an effort to secure eventual EU approval in the rejected indications. A third company, XBiotech, hasn’t ruled out similar action. New MAAs would be required.

Europe Approvals

Not Just Herceptin Biosimilar: Additional 12 Drugs Set For EU Marketing Approval After CHMP Nod

New treatments for plaque psoriasis and ovarian and prostate cancer join the first Herceptin biosimilar and several other products in garnering recommendations for EU marketing approval at September's meeting of EMA's key scientific committee, the CHMP. No decision was taken on Roche’s new MS drug, Ocrevus, and earlier negative opinions of three other products were upheld.

Europe Approvals

EU CHMP Decides On New Oncology Drugs & New Treatments for Mastocytosis, Atopic Dermatitis

The European Medicines Agency’s key scientific committee, the CHMP, is deciding this week whether a dozen or so new medicines that are in the final stages of the evaluation process should be approved for marketing across the EU. The committee will discuss 13 initial marketing authorization applications.

Approvals Regulation
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Company Information

  • Industry
  • Biotechnology
    • Large Molecule
  • Pharmaceuticals
  • Therapeutic Areas
  • Cancer
  • Inflammation
  • Neurology, Nervous System
  • Alias(es)
  • Ownership
  • Public
  • Headquarters
  • Worldwide
    • Europe
      • Western Europe
        • France
  • Parent & Subsidiaries
  • AB Science
  • Senior Management
  • Alain Moussy, CEO
    Laurent Guy, CFO
  • Contact Info
  • AB Science
    Phone: (33)
    3, Avenue George V
    Paris, 75008
    France
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