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Santhera Pharmaceuticals AG

www.santhera.com

Latest From Santhera Pharmaceuticals AG

Roche Fails Again To Convince CHMP On Ocrevus, Only Teva Gets A Thumbs Up

Roche has once again failed to convince the EMA’s key advisory panel, the CHMP, that the company’s novel multiple sclerosis treatment, Ocrevus (ocrelizumab), should be approved for marketing throughout Europe. The CHMP was considering an unusually low number of products for an opinion this month – just three – and only Teva’s generic tacrolimus got a positive recommendation. As with Ocrevus, no opinion was taken on the third product – carmustine, another generic.

Europe Regulation

Ocrevus Tries Again For EU Approval Nod

Just three initial marketing authorization applications are up for an opinion this week on whether they should be approved for sale across the EU. Roche’s new multiple sclerosis treatment, Ocrevus (ocrelizumab), is one, after failing to secure a positive opinion earlier. The October meeting of the panel that will decide, the European Medicines Agency’s CHMP, is under way in London.

Europe Regulation

Confident Catabasis Takes Positives From Failed Duchenne Trial Into Phase III

The US biotech has presented positive data from a mid-stage trial of edasalonexent that had previously missed its primary endpoint and hopes the goals it has set for Phase III will be enough to satisfy regulators.

Clinical Trials Inflammation

Duchenne Community Keeps The Faith After Dual New Product Setback

The DMD community could be forgiven for feeling disheartened by recent setbacks to potential new treatments in the US and EU. Patient power will not be enough to get DMD drugs past regulators but companies and advocacy groups are keeping the faith. Among other things, they hope that better natural history data may help their cause.

Rare Diseases Clinical Trials
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Company Information

  • Industry
  • Biotechnology
    • Drug Discovery Tools
  • Pharmaceuticals
    • Specialty Pharmaceuticals
  • Therapeutic Areas
  • Musculoskeletal & Connective Tissue Disorders
  • Neurology, Nervous System
  • Alias(es)
  • Graffinity Pharmaceuticals AG
  • MyoContract Pharmaceutical Research Ltd.
  • Graffinity Pharmaceutical Design GMBH
  • Ownership
  • Public
  • Headquarters
  • Worldwide
    • Europe
      • Western Europe
        • Switzerland
  • Parent & Subsidiaries
  • Santhera Pharmaceuticals AG
  • Senior Management
  • Thomas Meier, PhD, CEO
    Christoph Rentsch, CFO
    Gunther Metz, EVP, Head Bus. Dev.
    Kristina Sjöblom Nygren, CMO & EVP, Head Dev.
  • Contact Info
  • Santhera Pharmaceuticals AG
    Phone: (41) 61 906 89 50
    Hammerstrasse 49
    Liestal, CH-4410
    Switzerland
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