Printer Friendly
The Free Library
4,630,335 articles and books
Member login
User name  
Password 
 
Join us Forgot password?

ROCHE TO SUBMIT MORE TAMIFLU DATA TO EURO AUTHORITIES.


Roche and Gilead Sciences Gilead Sciences NASDAQ: GILD is a biopharmaceutical company that discovers, develops and commercializes therapeutics to advance the care of patients suffering from life-threatening diseases. , Inc. (Nasdaq:GILD) have announced that Roche has decided to withdraw the European application for the antiviral antiviral /an·ti·vi·ral/ (-vi´ral) destroying viruses or suppressing their replication, or an agent that so acts.

an·ti·vi·ral
adj.
 Tamiflu (oseltamivir) for the treatment of influenza in order to have more time to submit further data. Some members of the Committee for Proprietary Medicinal Products (CPMP CPMP Committee for Proprietary Medicinal Products
CPMP Core-Plus Mathematics Project
CPMP Crew Procedures Management Plan (NASA)
CPMP Canadian Project Management Professional
CPMP Corporate Planning and Management Practices
) raised questions, for which additional data will be available in the near future. Withdrawal of the application allows Roche the opportunity to provide this information to European regulatory authorities. The application will be resubmitted as soon as possible.

Roche is continuing to pursue regulatory approvals around the world. The first submission for the prophylaxis prophylaxis (prō'fĭlăk`sĭs), measures designed to prevent the occurrence of disease or its dissemination. Some examples of prophylaxis are immunization against serious diseases such as smallpox or diphtheria; quarantine to confine  of influenza was recently submitted to the Food and Drug Administration (FDA FDA
abbr.
Food and Drug Administration


FDA,
n.pr See Food and Drug Administration.

FDA,
n.pr the abbreviation for the Food and Drug Administration.
) in the United States United States, officially United States of America, republic (2005 est. pop. 295,734,000), 3,539,227 sq mi (9,166,598 sq km), North America. The United States is the world's third largest country in population and the fourth largest country in area. .

Tamiflu is already available for the treatment of influenza in nine countries worldwide including the United States, Canada, Switzerland and many Latin American countries based upon its demonstrated safety, efficacy and tolerability. Hundreds of thousands of sufferers were treated with Tamiflu during the last influenza season. Roche believes that Tamiflu will play an important role both in the prevention and the treatment of influenza, a disease affecting 100 million people worldwide annually, which is still not treated effectively. Treatment studies involving more than 7,000 patients with oral Tamiflu have shown a significant reduction in both duration and severity of symptoms, including fever and cough.

Tamiflu, co-developed with Gilead Sciences, USA, is a systemic treatment for influenza, designed to reach all key sites of infection in the body including the upper and lower respiratory tracts. The medication targets one of two major surface structures on the influenza virus influenza virus
n.
Any of three viruses of the genus Influenzavirus designated type A, type B, and type C, that cause influenza and influenzalike infections.
, the neuraminidase neuraminidase /neu·ra·min·i·dase/ (-ah-min´i-das) an enzyme of the surface coat of myxoviruses that destroys the neuraminic acid of the cell surface during attachment, thereby preventing hemagglutination.  protein. The neuraminidase is virtually the same in all common strains of influenza. If neuraminidase is inhibited, the virus is not able to infect new cells.

Gilead Sciences, Inc., headquartered in Foster City, CA is an independent biopharmaceutical company that seeks to provide accelerated solutions for patients and the people who care for them. Gilead discovers, develops, manufactures and commercializes proprietary therapeutics for challenging infectious diseases (viral, fungal and bacterial infections) and cancer. Gilead maintains research, development or manufacturing facilities in Foster City, CA; Boulder, CO; San Dimas, CA; Cambridge, UK and Dublin, Ireland and sales and marketing organizations in United States, Europe and Australia.

Headquartered in Basel, Switzerland, Roche is one of the world's leading research-oriented healthcare groups in the fields of pharmaceuticals, diagnostics and vitamins. Roche's innovative products and services address prevention, diagnosis and treatment of diseases, thus enhancing people's well-being and quality of life.

For more information, call 973/562-2212.
COPYRIGHT 2000 Worldwide Videotex
No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 2000, Gale Group. All rights reserved. Gale Group is a Thomson Corporation Company.

 Reader Opinion

Title:

Comment:



 

Article Details
Printer friendly Cite/link Email Feedback
Comment:ROCHE TO SUBMIT MORE TAMIFLU DATA TO EURO AUTHORITIES.
Publication:Worldwide Biotech
Geographic Code:1USA
Date:Jul 1, 2000
Words:421
Previous Article:BIOSYNTECH/BIOMET TO DEVELOP NEW HARD TISSUE HEALING.(Brief Article)
Next Article:BABIES TO BE SCREENED FOR DIABETES RISK GENES IN SWEDEN.(Brief Article)
Topics:



Related Articles
Treasury and Federal Reserve Foreign Exchange Operations.(Statistical Data Included)
Treasury and Federal Reserve Foreign Exchange Operations.
Hepatitis C: FDA public meeting on peginterferon plus ribavirin, Nov. 14.
Prepare for the worst.(Editorials)(U.S. needs to plan carefully for bird flu outbreak)(Editorial)
International drug access: NGOs urge countries "reject bad deal on medicines".
Viral resistance: Deja vu?(EDITORIAL)
Tamiflu swan song? Building resistance to top avian flu drug.(Science Selections)
Potential risks associated with the proposed widespread use of Tamiflu.(Research)
An outbreak of new sources of avian flu drug.(PHARMACEUTICALS)
Spammers peddle drugs to combat bird flu.(Security News)

Terms of use | Copyright © 2008 Farlex, Inc. | Feedback | For webmasters | Submit articles