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Curemark LLC

Latest From Curemark LLC

Autism Feedback To FDA: Focus On Communication, Redefine 'Irritability'

US FDA’s 22nd Patient-Focused Drug Development meeting focused on the challenging disease of autism. It also showed how far FDA has come in embracing the patient-input process over the past five years.

Drug Approval Standards FDA

FDA Autism Meeting: Will It Stray From Symptoms And Treatments To Causation?

US agency may face challenge of keeping May 4 meeting on patient-focused drug development focused on autism disease burden and current therapeutic approaches rather than vaccine safety.

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PIPELINE WATCH: Four Approvals, Six Filings And Three Launches

This week's Pipeline Watch, a snapshot of all the late-stage R&D and regulatory events in the pharma and biotech industries, is now available to view.

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EMA Autism Guidance Pushes Sponsors To Tackle Core Symptoms

While short-term efficacy in core symptoms should be demonstrated first, EMA draft drug development guidance also calls for a showing of positive effect on global function and maintenance of long-term efficacy.

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Company Information

  • Industry
  • Biotechnology
    • Large Molecule
  • Pharmaceuticals
  • Therapeutic Areas
  • Neurology, Nervous System
  • Alias(es)
  • Ownership
  • Private
  • Headquarters
  • Worldwide
    • North America
      • USA
  • Parent & Subsidiaries
  • Curemark LLC
  • Senior Management
  • Joan Fallon, MD, CEO
    Matthew Heil, PhD, CSO
  • Contact Info
  • Curemark LLC
    Phone: (914) 925-3450
    411 Theodore Fremd Ave.
    Ste. 206 S.
    Rye, NY 10580