Free press releases distribution network?

Agency / Source: Alto Marketing Ltd

Check Ads Availability|e-mail Article


Are you the owner of this article?, Turn it PREMIUM with your LOGO instead - and make it 3rd party Ads-Free! within the next hour!



Biopartners Withdrew the Application for Marketing Authorisation for Biferonex® - The European Medicines Agency has been formally notified by BioPartners GmbH of its decision to withdraw the application for a centralised marketing authorisation for Biferonex
Biopartners Withdrew the Application for Marketing Authorisation for Biferonex®

 

PRZOOM - /newswire/ - Baar, Switzerland, 2009/06/01 - The European Medicines Agency has been formally notified by BioPartners GmbH of its decision to withdraw the application for a centralised marketing authorisation for Biferonex.

   
 
Your Banner Ad Here instead - Showing along with ALL Articles covering Pharma/BioTech/Nutrition Announcements

Replace these Affiliate Programs at ANYTIME! Your banner here within the next hour. Learn How!


 

The European Medicines Agency has been formally notified by BioPartners GmbH of its decision to withdraw the application for a centralised marketing authorisation for Biferonex (interferon beta 1a), 6MIU, solution for injection in prefilled syringes.

Biferonex is developed to treat adults with relapsing-remitting multiple sclerosis.

The application for the marketing authorisation for Biferonex was submitted to the Agency in July 2007. On 19 February 2009, the Agency's Committee for Medicinal Products for Human Use (CHMP) adopted a negative opinion, recommending the non-granting of the marketing authorisation. Following this, the company requested a re-examination of the opinion, which was under review by the CHMP at the time of the withdrawal.
This decision was taken because the CHMP considered the benefit not to be sufficiently established by the submitted data.

In the view of Biopartners, the data in place are substantial and the body of evidence is strong in support of the products safety and efficacy. A positive risk/benefit profile is adequately established and it is very much comparable to the one known from the other interferon beta products approved in the EU for treatment of relapsing-remitting multiple sclerosis.

Biopartners reserve the right to make further submissions at a future date in this or other therapeutic indication(s).

For further information on Biopartners please contact:
Marie-Joëlle Gaufrès, Head of Commercial Operations
E: marie-joelle[.]Biopartners.ch
P: +41 (0)41 766 20 80

About Biopartners GmbH
Headquartered in Baar, Switzerland, with an affiliate in Germany, Biopartners (biopartners.ch) is a global biopharmaceuticals company and a leader in the emerging field of multi-source biopharmaceuticals. Biopartners’ mission is to develop optimized first generation biopharmaceuticals and second generation innovative formulations, such as long-acting forms that may improve patient compliance. Biopartners is developing a comprehensive range of biopharmaceutical products that may offer clinically relevant therapeutic benefits across several therapeutic areas.

About the Bioton Group S.A.
Bioton S.A. has a portfolio of 32 products – among them the key product: Recombinant Human Insulin. The company’s intention is to systematically increase the share of medicinal products based on the substances produced via biosynthesis. The introduction of recombinant human insulin enabled Bioton S.A. to join the small group of companies in the world that manufacture this substance. Bioton S.A. aims to continuously develop an attractive portfolio that will include high-margin products of a high therapeutic efficacy.

 
 
Your Banner Ad Here instead - Showing along with ALL Articles covering Pharma/BioTech/Nutrition Announcements

Replace these Affiliate Programs at ANYTIME! Your banner here within the next hour. Learn How!


 

Agency / Source: Alto Marketing Ltd

 
 

Availability: All Regions (Including Int'l)

 

Traffic Booster: [/] Quick PRZOOM - Press & Newswire Visibility Checker

 

Distribution / Indexing: [+]

 
 
# # #
 

 
  Your Banner Ad showing on ALL
Pharma/BioTech/Nutrition articles,
CATCH Visitors via Your Competitors Announcements!


Biopartners Withdrew the Application for Marketing Authorisation for Biferonex®

Company website links NOT available to basic submissions
It is OK to republish and/or LINK any newswire for any legitimate media purpose as long as you name PRZOOM - Press & Newswire and LINK as the source.
 
  For more information, please visit:
Is this your article? Activate ALL web links by Upgrading to Press Release PREMIUM Plan Now!
|
Contact: Leigh Dilley 
+44 1489 557672 clarer[.]alto-marketing.com
 
PRZOOM / PRTODAY - Newswire Today disclaims any content contained in this article. If you need/wish to contact the company who published the current release, you will need to contact them - NOT us. Issuers of articles are solely responsible for the accuracy of their content. Our complete disclaimer appears here.
IMPORTANT INFORMATION: Issuance, publication or distribution of this press release in certain jurisdictions could be subject to restrictions. The recipient of this press release is responsible for using this press release and the information herein in accordance with the applicable rules and regulations in the particular jurisdiction. This press release does not constitute an offer or an offering to acquire or subscribe for any Alto Marketing Ltd securities in any jurisdiction including any other companies listed or named in this release.

Pharma/BioTech/Nutrition via RSSAdd NewswireToday - PRZOOM Headline News to FeedBurner
Find who RetweetFollow @NewswireTODAY



Are you the owner of this article?, Turn it PREMIUM with your LOGO instead - and make it 3rd party Ads-Free! within the next hour!




Read Latest Press Releases From Alto Marketing Ltd / Company Profile


Read Pharma/BioTech/Nutrition Most Recent Related Press Releases:

Frost & Sullivan Commends Nemaura for Developing Superior Transdermal Drug Delivery Technology Platforms, the Memspatch and Micropatch
Greenphire Sponsors Second Annual Clinical Trial Agreements, Investigator Payments and Fair Market Value Meeting
Genentech’s Gazyva Helped People with Previously Untreated Follicular Lymphoma Live Significantly Longer
BD Announces Adoption of Windows 10 ‘Internet of Things’ for the Pyxis™ ES System
Greenphire Named to Deloitte 2016 Technology Fast 500™
Genentech Showcases New Clinical Data Across a Variety of Blood Diseases at American Society of Hematology 2016 Annual Meeting
BD Collaborates with JDRF to Focus on Extended Wear Innovations for Insulin Infusion Delivery
BD Launches First Syringe Designed for Use with Humulin® R U-500 Insulin
MDxHealth Announces Unique CPT Code Awarded for ConfirmMDx from the American Medical Association
BD MAX™ Vaginal Panel Receives FDA Market Authorization to Detect Most Common Causes of Vaginal Infections

Boost Your Social Network
& Crowdfunding Campaigns


LIFETIME SOCIAL MEDIA WALL
 
NewswireToday Celebrates 10 Years in Business
Find business coaching, life coaching, executive coaching and corporate coaching, best selling coaching books, ...



PREMIUM Members


Visit  JobsWare.com

Visit  La Bella Bakery Artisan Bakery Arizona

Visit  BizJobs.com







 
  ©2016 PRZOOM — Limelon Advertising, Co.
Home | About PRZOOM | Advertise/Pricing | Contact | Investors | Privacy/TOS | Sitemap | FRANCAIS
newswire, PR free press releases distribution service magazines engine news alert newsroom press room breaking news public relations articles company news alerts newswiredistribution ezine bizentrepreneur biznewstoday digital business report market search pr firms agencies reports distri-bution today investor relation successful internet entrepreneur newswire distribution prtoday.com freenewswiredistribution asianewstoday bizwiretoday USA pr UK today