We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
Accept
  • SKIP TO CONTENT
  • SKIP NAVIGATION
  • Drug & Device Products
    • FDAnews Books Library
    • Events
    • Form 483s Database
    • Publications
    • Webinar Training Pass
    • eCFR and Guidances
    • Books
  • Clinical Products
  • Advertising
  • White Papers
  • Contact Us
  • About Us
  • COVID-19
  • Sign In
  • Create Account
  • Sign Out
  • My Account
Home » Aduro’s CRS-207 for Mesothelioma Wins Orphan Drug Status From EMA

Aduro’s CRS-207 for Mesothelioma Wins Orphan Drug Status From EMA

December 2, 2015

The European Medicines Agency has granted Aduro Biotech’s mesothelioma candidate orphan drug designation.

Given orphan status by the FDA in March, CRS-207 immunotherapy is being tested alongside standard chemotherapy in a Phase 1b study for patients with malignant pleural mesothelioma. The drugmaker says it will launch a similar Phase 3 trial in the first half of next year, skipping mid-stage research to propel the candidate forward.

The EMA decision offers sponsors special protections designed to spur development in rare diseases, including scientific advice and up to 10 years of EU marketing exclusivity.

Aduro says the designation will benefit the company as it grows its presence in the European market.

Pharmaceuticals Submissions and Approvals

Upcoming Events

  • 09Feb

    The Inextricable Link Between Data Integrity and Quality Culture

  • 15Feb

    Advanced Compliance Writing CAPA: Mastering Failure Investigation and Root Cause Analysis

  • 16Feb

    Fundamentals of FDA Inspection Management: Reduce Anxiety, Increase Inspection Success

  • 22Feb

    Best Practices for Developing and Maintaining a GxP Training Matrix

  • 07Mar

    FDA’s Remote Assessments v. Remote Interactive Evaluations: Do You Really Know the Difference?

  • 08Mar

    Medical Device Cybersecurity: The Regulatory Landscape and How to Defend Your Practices During an Inspection

Featured Products

  • FDA’s New Quality System Regulation: Transitioning from QSR to ISO 13485

    FDA’s New Quality System Regulation: Transitioning from QSR to ISO 13485

  • Selecting and Implementing Electronic Document Management Systems in the EU

    Selecting and Implementing Electronic Document Management Systems in the EU

Featured Stories

  • Boston Scientific’s Single Use Ureteroscope Gets FDA Clearance

  • Gilead’s Trodelvy Gets Expanded Approval in Breast Cancer

  • AI Software to Improve Echocardiogram Images Gets FDA Clearance

The Revised ICH E8: A Guide to New Clinical Trial Requirements

Learn More
  • Drug Products
    • Quality
    • Regulatory Affairs
    • GMPs
    • Inspections and Audits
    • Postmarket Safety
    • Submissions and Approvals
    • Research and Development
    • Commercial Operations
  • Device Products
    • Quality
    • Regulatory Affairs
    • QSR
    • Inspections and Audits
    • Postmarket Safety
    • Submissions and Approvals
    • Research and Development
    • Commercial Operations
  • Clinical Products
    • Trial Design
    • Data Integrity
    • GCP
    • Inspections and Audits
    • Transparency
  • Privacy Policy
  • Do Not Sell or Share My Data
Footer Logo

300 N. Washington St., Suite 200, Falls Church, VA 22046, USA

Phone 703.538.7600 – Toll free 888.838.5578

Copyright © 2023. All Rights Reserved. Design, CMS, Hosting & Web Development :: ePublishing