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EMD Serono Inc.

Division of Merck KGaA
www.emdserono.com

Latest From EMD Serono Inc.

Biogen Vumerity Receives Full US Approval, But GI Comparison With Tecfidera Must Wait

Label offers little differentiation from Tecfidera, but head-to-head trial with custom-designed patient-reported outcome could make case for gastrointestinal tolerability advantage.

Real-World Evidence: Sponsors Look To US FDA Drug Reviews For Potential Pitfalls

Methodological problems with RWE submissions for approved applications may give sponsors ‘a little bit of a pause’ as they work through data selection and analytical issues, Aetion’s Jeremy Rassen says. CDER’s Janet Woodcock says it is easier to use RWE when treatment effects are large.

Drug Approval Standards Research and Development Strategies

Amgen’s Nonconformist Position On Biosimilar Payment Policy Reflects Market Strategy

Company objects to legislative proposals that would enhance Medicare Part B reimbursement for biosimilars to boost uptake, even as it launches its first biosimilars in the US market.

Biosimilars Reimbursement

US FDA Approval Actions To Watch Out For In June

User fee goal date calendar for June includes AMAG’s female sexual dysfunction drug Vyleesi, new indications for Sanofi/Regeneron’s Dupixent in rhinosinusitis and Merck’s Zerbaxa in nosocomial pneumonia.

Drug Review Drug Approval Standards
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Company Information

  • Industry
  • Pharmaceuticals
  • Therapeutic Areas
  • Non-Specific
  • Alias(es)
  • Ownership
  • Private
  • Headquarters
  • Worldwide
    • North America
      • USA
  • Parent & Subsidiaries
  • Merck KGaA
  • Senior Management
  • Zhen Su, MD, CMO, North America
    Rehan Verjee, Pres.
  • Contact Info
  • EMD Serono Inc.
    Phone: (800) 283-8088
    One Technology Pl.
    Rockland, MA 02370
    USA
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