PRTODAY / NewswireToday Free press release distribution service network

Written by / 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®

 

NewswireToday - /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!


 

Written by / Agency / Source: Alto Marketing Ltd

 
 

Availability: All Regions (Including Int'l)

 

Traffic Booster: [/] Quick Newswire Today 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 Newswire Today and LINK as the source.
 
  Is this your article?
Activate ALL web links and social stream by Upgrading to Press Release PREMIUM Plan Now!

|
Publisher Contact: Leigh Dilley 
+44 1489 557672 clarer[.]alto-marketing.com
 
Newswire Today - PRZOOM / PRTODAY 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 Articles From Alto Marketing Ltd / Company Profile


Read Pharma/BioTech/Nutrition Most Recent Related Newswires:

Sub-Sahara Africa - Increase in Western Lifestyles Leads to Dire Need for Chronic Prescription Drugs Finds Frost & Sullivan
BD Initiates New Industry Alliance to Combat Rising Opioid Crisis
BTG and Society of Interventional Oncology to Explore Role of Minimally Invasive Therapies in Immuno-oncology
Ipsen to Acquire a Portfolio of Select Consumer Healthcare Products from Sanofi
BD Announces Early Access Program for BD Resolve™ Single-Cell Analysis Platform
Precision Medicine Unlocks the Future of Targeted Therapy in the Global Healthcare Industry Finds Frost & Sullivan
Sciformix Corporation Receives Prestigious 2017 Global Outsourcing Customer Service Leadership Award from Frost & Sullivan
Arven Pharmaceuticals Selects GE Healthcare’s FlexFactory to Improve Turkish and Regional Access to Biopharmaceuticals
Ipsen to Acquire Primary Care Platform in Italy from Akkadeas Pharma
Cost-Containment and Client-Centric Services Catalyse European Custom Procedure Trays and Packs Market Finds Frost & Sullivan
New BD Institute for Medication Management Excellence Aims to Improve Patient Safety and Outcomes through Collaboration
New Varicose Vein Treatment Offers Minimally Invasive Non Surgical Procedure to Canadians
Greenphire and Exostar Partner to Deliver Seamless, Secure Access to Clinical Research Site Payment Solution
PleurX™ Catheter System Receives FDA 510(k) Clearance for Specific Non-Malignant Recurrent Pleural Effusions
First Pulmonary Embolism Patients in Hong Kong Treated with the EKOS® System

Boost Your Social Network
& Crowdfunding Campaigns


LIFETIME SOCIAL MEDIA WALL
NewswireToday Celebrates 10 Years in Business


PREMIUM Members


Visit  BizJobs.com

Visit  Al Rowaad Advocates & Legal Consultants





 
  ©2017 Newswire Today — Limelon Advertising, Co.
Home | About | 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 entrepreneurs newswire distribution prtoday.com freenewswiredistribution asianewstoday bizwiretoday USA pr UK today - NOT affiliated with PRNewswire as we declined their partnership offer in 2013
 
PRTODAY & NewswireTODAY are NOT affiliated with USA TODAY (usatoday.com)