Medical Design and Outsourcing

  • Home
  • Medical Device Business
    • Mergers & Acquisitions
    • Financial
    • Regulatory
  • Applications
    • Cardiovascular
    • Devices
    • Imaging
    • Implantables
    • Medical Equipment
    • Orthopedic
    • Surgical
  • Technologies
    • Contract Manufacturing
    • Components
    • Electronics
    • Extrusions
    • Materials
    • Motion Control
    • Prototyping
    • Pumps
    • Tubing
  • Med Tech Resources
    • DeviceTalks Tuesdays
    • Digital Editions
    • eBooks
    • Manufacturer Search
    • Medical Device Handbook
    • MedTech 100 Index
    • Podcasts
    • Print Subscription
    • The Big 100
    • Webinars / Digital Events
    • Whitepapers
    • Video
  • 2022 Leadership in MedTech
    • 2022 Leadership Voting!
    • 2021 Winners
    • 2020 Winners
  • Women in Medtech

FDA Grants Fast Track Designation to Bayer’s Investigational Compound Radium-223 Chloride for the Treatment of Castration-Resistant Prostate Cancer That Has Spread to the Bone

August 23, 2011 By Bio-Medicine.Org

WAYNE, N.J., Aug. 23, 2011 /PRNewswire/ — Bayer HealthCare
Pharmaceuticals, Inc. today announced that its investigational
compound radium-223 chloride, which is exclusively licensed from
Algeta ASA, has been granted Fast Track designation by the U.S.
Food and Drug Administration (FDA) for the treatment of
castration-resistant (hormone-refractory) prostate cancer in
patients with bone metastases.

Radium-223 chloride is an investigational agent and is not
approved by the FDA, the European Medicines Agency (EMA) or other
Health Authorities.

“We are pleased that the FDA has granted Fast Track designation
to radium-223 chloride,” said Kemal Malik, MD, Head of Global
Development and member of the Bayer HealthCare Executive Committee.
“This is an important milestone in the overall development of this
compound.”

Fast Track Designation in the United States

Fast Track is a process designed to facilitate the development,
and expedite the review of drugs to treat serious diseases and fill
an unmet medical need. Fast Track addresses a broad range of
serious diseases. Fast Track designation must be requested by the
drug company and can be initiated at any time during the drug
development process. Once a drug receives Fast Track designation,
early and frequent communication between the FDA and a drug company
is encouraged throughout the entire drug development and review
process. The frequency of communication assures that questions and
issues are resolved quickly, often leading to earlier drug approval
and access by patients.

About Radium-223 Chloride

Radium-223 chloride is an investigational pharmaceutical
containing an alpha-particle emitting nuclide in development for
cancer patients with bone metastases. In September 2009, Bayer
signed an agreement with Algeta ASA (Oslo, Norway) for the
development and commercialization of radium-223 chloride. Under the
terms of the agreement, Bayer will develop, apply for

‘/>”/>

SOURCE

Related Articles Read More >

Engineer inspecting artificial hip joint parts in quality control department in orthopaedic factory
Deburring and finishing for beautiful, functional medical devices
A Medtronic HVAD pump opened up to show the inner workings
FDA designates new Medtronic HVAD pump implant recall as Class I
Dexcom One
How Dexcom’s portfolio goes beyond highly-anticipated next-gen G7
A portrait of Stryker executive Siddarth Satish
How Stryker includes users for product design in the digital age

DeviceTalks Weekly.

June 24, 2022
How innovative design, commercial strategy is building Cala Trio’s bioelectronic medicine market
See More >

MDO Digital Edition

Digital Edition

Subscribe to Medical Design & Outsourcing. Bookmark, share and interact with the leading medical design engineering magazine today.

MEDTECH 100 INDEX

Medtech 100 logo
Market Summary > Current Price
The MedTech 100 is a financial index calculated using the BIG100 companies covered in Medical Design and Outsourcing.
DeviceTalks

DeviceTalks is a conversation among medical technology leaders. It's events, podcasts, webinars and one-on-one exchanges of ideas & insights.

DeviceTalks

New MedTech Resource

Medical Tubing

Enewsletter Subscriptions

Enewsletter Subscriptions

MassDevice

Mass Device

The Medical Device Business Journal. MassDevice is the leading medical device news business journal telling the stories of the devices that save lives.

Visit Website
MDO ad
Medical Design and Outsourcing
  • MassDevice
  • DeviceTalks
  • MedTech 100 Index
  • Medical Tubing + Extrusion
  • Drug Delivery Business News
  • Drug Discovery & Development
  • Pharmaceutical Processing World
  • R&D World
  • About Us/Contact
  • Advertise With Us
  • Subscribe to Print Magazine
  • Subscribe to E-newsletter
  • Attend our Monthly Webinars
  • Listen to our Weekly Podcasts
  • Join our DeviceTalks Tuesdays Discussion

Copyright © 2022 WTWH Media, LLC. All Rights Reserved. The material on this site may not be reproduced, distributed, transmitted, cached or otherwise used, except with the prior written permission of WTWH Media LLC. Site Map | Privacy Policy | RSS

Search Medical Design & Outsourcing

  • Home
  • Medical Device Business
    • Mergers & Acquisitions
    • Financial
    • Regulatory
  • Applications
    • Cardiovascular
    • Devices
    • Imaging
    • Implantables
    • Medical Equipment
    • Orthopedic
    • Surgical
  • Technologies
    • Contract Manufacturing
    • Components
    • Electronics
    • Extrusions
    • Materials
    • Motion Control
    • Prototyping
    • Pumps
    • Tubing
  • Med Tech Resources
    • DeviceTalks Tuesdays
    • Digital Editions
    • eBooks
    • Manufacturer Search
    • Medical Device Handbook
    • MedTech 100 Index
    • Podcasts
    • Print Subscription
    • The Big 100
    • Webinars / Digital Events
    • Whitepapers
    • Video
  • 2022 Leadership in MedTech
    • 2022 Leadership Voting!
    • 2021 Winners
    • 2020 Winners
  • Women in Medtech