Navigation Links
The European Medicines Agency Completes Validation Stage for InterMune's Marketing Authorization Application for pirfenidone
Date:3/23/2010

d would expand its commercial infrastructure to support European marketing efforts. Given the significant unmet medical need for medications to treat patients with IPF, the approval of pirfenidone in Europe would represent a second and important value-creation opportunity to that represented by the U.S. market.

U.S. Regulatory Status

The New Drug Application (NDA) for pirfenidone was submitted by InterMune to the United States Food and Drug Administration (FDA) in early November 2009. On January 4, 2010, InterMune announced that the FDA granted Priority Review designation for its New Drug Application (NDA) for pirfenidone for the treatment of IPF. Priority Review designation may be granted by the FDA to an NDA for drugs that have the potential to offer major advances in treatment, or provide a treatment where no adequate therapy exists. Based on the Prescription Drug User Fee Act, the FDA has set an action date for the NDA of May 4, 2010. On March 9, the FDA's Pulmonary-Allergy Drugs Advisory Committee (PADAC) voted 9-3 to recommend the approval of pirfenidone for the treatment of U.S. patients with IPF to reduce decline in lung function.

About Esbriet® (pirfenidone)


'/>"/>
SOURCE InterMune, Inc.
Copyright©2010 PR Newswire.
All rights reserved

Page: 1 2 3 4 5 6 7

Related medicine news :

1. Promega Maxwell 16 IVD System CE Marked to the European Union IVD Directive Delivers Combined Solution for Infectious Disease
2. Yondelis(R) Receives Five New Approvals Outside the European Economic Area
3. International Collaboration: FDA and European Medicines Agency Agree to Accept a Single Orphan Drug Designation Annual Report
4. United Therapeutics Corporation Withdraws European Marketing Authorization Application for Tyvaso for the Treatment of Pulmonary Arterial Hypertension
5. Your e-Marketing Journey in 2010: An e-Book for Corporate Communicators Working in European Headquarters
6. Lower detection of prostate cancer with PSA screening in US than in a European randomized trial
7. European Cancer Organization supports a revision of the EU Clinical Trials Directive
8. Abbott Receives European Regulatory Approval for New Ovarian Cancer Diagnostic Test
9. Cardiome Announces Investigational Candidate, Vernakalant, Meets Primary Endpoint in European Comparator Study
10. The European Society of Cardiology Textbook of Cardiovascular Imaging puts patient at center
11. Reportlinker Adds European Markets for Interventional Cardiology 2009 (15 Countries)
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:9/2/2014)... Fort Lauderdale, Florida (PRWEB) September 02, 2014 ... Joint Commission Accredited teleradiology and telemedicine solutions provider, ... attention with its innovative and technologically advanced services. ... Dar Al Shifa Hospital in Kuwait. , Founded ... hospital in Kuwait, Dar Al Shifa began as ...
(Date:9/2/2014)... A little bit of moodiness now and then ... irritability, sadness, or apathy can be a sign of ... Health Letter. , "Mood-related symptoms can come and ... for long periods, cause significant distress, or interfere with ... Dr. Nancy Donovan, an instructor in psychiatry at Harvard ...
(Date:9/2/2014)... (PRWEB) September 02, 2014 MyRounding, the ... care, has been selected from a group of over ... the 2014 PrIME Digital Health Challenge. The competition will ... another, Tuesday, Sept. 9th at the CSU Denver Atrium ... MyRounding is based in Denver, Colo. The cloud-based, SaaS ...
(Date:9/2/2014)... FL (PRWEB) September 02, 2014 ... that they are gathering content for upcoming episodes ... to air first quarter 2015. , Innovations, hosted ... and exploring today's latest breakthroughs and advancements taking ... series will focus on advancements in biosciences. Biosciences ...
(Date:9/2/2014)... September 02, 2014 With thoughts of ... on the minds of many Washingtonians, it’s easy to ... planners and office managers to be booking their organizations’ ... & Resorts' Washington, DC, area locations are preparing for ... dates available for holiday parties, the space appears to ...
Breaking Medicine News(10 mins):Health News:USARAD Holdings Inc. SECONDOPINIONS.COM® Partners With Prestigious Dar Al Shifa Hospital In Kuwait 2Health News:USARAD Holdings Inc. SECONDOPINIONS.COM® Partners With Prestigious Dar Al Shifa Hospital In Kuwait 3Health News:USARAD Holdings Inc. SECONDOPINIONS.COM® Partners With Prestigious Dar Al Shifa Hospital In Kuwait 4Health News:When a Mood Swing Signals Trouble, From the September 2014 Harvard Health Letter 2Health News:MyRounding Selected for Digital Health Venture Showcase Finals Top Three Startups Awarded $50,000 2Health News:Exciting New Episodes of Innovations with Ed Begley Jr to Air via Discovery Channel 2Health News:Fall in Washington, DC, Is When a Meeting Planner’s Mind Turns to … the Winter Holidays? 2Health News:Fall in Washington, DC, Is When a Meeting Planner’s Mind Turns to … the Winter Holidays? 3Health News:Fall in Washington, DC, Is When a Meeting Planner’s Mind Turns to … the Winter Holidays? 4Health News:Fall in Washington, DC, Is When a Meeting Planner’s Mind Turns to … the Winter Holidays? 5
... matter, eating something that,s considered healthy might simply lead us ... new study in the Journal of Consumer Research . ... Chicago) examined external controls in the domain of healthy eatingsuch ... consumers who eat healthy meals in a cafeteria that only ...
... Care bill in the midnight hours "the largest expansion of the federal government in American history and a tragic mistake. Elections have consequences. The only remedy for this ... ... ... ...
... , March 22 Children,s Health Fund (CHF) ... and applauds Congress for its steadfast commitment to this momentous ... is a fundamental right, especially for children.  The action taken ... for the health and well-being of all children in this ...
... Bunker Hill Community College will dedicate a new Health & Wellness Center on Tuesday, March ... at the event will be Massachusetts Lieutenant Governor Tim Murray , State Representative Eugene L. O,Flaherty , ... ... , ...
... deaf, might you still be able to hear the sound? ... MD, director of the Adult Cochlear Implant Program at the ... people who have diseases and disorders related to hearing, swallowing, ... investigational device that will enable people who have lost hearing ...
... ... efficient solution to reduce the costs for building a web site. Website Realizer 1.0 provides ... line of code. , ... March 22, 2010 -- Adritech Software has announced the launch of Website Realizer , ...
Cached Medicine News:Health News:Healthy food makes consumers feel hungrier when choices are limited 2Health News:Bauer Says the Only Remedy for the "Tragic Mistake" of the Health Care Vote Is at the Ballot Box 2Health News:Statement by Irwin Redlener, MD, President, Children's Health Fund on Passage of a Health Care Reform Package by the House 2Health News:Statement by Irwin Redlener, MD, President, Children's Health Fund on Passage of a Health Care Reform Package by the House 3Health News:BHCC Dedicates 48,000-Square-Foot Health & Wellness Center 2Health News:BHCC Dedicates 48,000-Square-Foot Health & Wellness Center 3Health News:UC center chosen to study auditory brain stem implants 2Health News:UC center chosen to study auditory brain stem implants 3Health News:Adritech Software Releases Website Realizer, a Website Builder to Create Websites without Any Programming Knowledge 2
(Date:9/2/2014)... 2014 According to a new ... Global Industry Analysis, Size, Share, Growth, Trends and Forecast, ... CAGR of 10.1% from 2014 to 2020. ... are used in the treatment and prevention of various ... other medical disorders. Biological drugs include therapeutic proteins, monoclonal ...
(Date:9/2/2014)... Sept. 2, 2014  For over a decade SafeMinds has ... between vaccines and autism. But at least for one study, ... a statement , William Thompson , Ph.D. acknowledged ... the MMR vaccine to an increased risk of autism in ... same data suggests that African American males have a 340% ...
(Date:9/2/2014)... Calif. , Sept. 2, 2014 ... today an increase in capital and cash advance ... Intuitive Surgical System,s da Vinci Robot. With over ... product, Legal-Bay focuses on providing lawsuit cash advances ... injuries, nerve damage, lacerations to internal organs, burns ...
Breaking Medicine Technology:CAGR of 10.1% Global Biological Drugs Market - Industry Analysis, Size, Share, Growth, Trends and Forecast 2014 to 2020: Report by MarketResearchReports.Biz 2CAGR of 10.1% Global Biological Drugs Market - Industry Analysis, Size, Share, Growth, Trends and Forecast 2014 to 2020: Report by MarketResearchReports.Biz 3CAGR of 10.1% Global Biological Drugs Market - Industry Analysis, Size, Share, Growth, Trends and Forecast 2014 to 2020: Report by MarketResearchReports.Biz 4CAGR of 10.1% Global Biological Drugs Market - Industry Analysis, Size, Share, Growth, Trends and Forecast 2014 to 2020: Report by MarketResearchReports.Biz 5CAGR of 10.1% Global Biological Drugs Market - Industry Analysis, Size, Share, Growth, Trends and Forecast 2014 to 2020: Report by MarketResearchReports.Biz 6CDC vaccine scientist admits wrongdoing. 2CDC vaccine scientist admits wrongdoing. 3da Vinci Lawsuit Settlement Funding Amounts Increased at Legal-Bay Funding 2da Vinci Lawsuit Settlement Funding Amounts Increased at Legal-Bay Funding 3
... Aug. 25 David N. Jonas, Chairman and CEO ... R. Spalding to the company,s Board of Directors. ... Crawford Spalding Group, an advisory and management services firm ... assist companies primarily in the healthcare services industry.  Jonas ...
... Conn., Aug. 25 Biodel Inc. (Nasdaq: BIOD ... with two institutional investors to sell 2,398,200 shares of its ... common stock.  The common stock and warrants are being sold ... common stock and a warrant to purchase one share of ...
Cached Medicine Technology:Biodel to Raise $9.4 Million Through Registered Direct Offering 2Biodel to Raise $9.4 Million Through Registered Direct Offering 3
The BacT/Alert 3D Select Link is a state of the art, automated microbial detection system that integrates blood, sterile body fluid and mycobacteria culturing. This system is useful when patient data...
The Vitek 2 is a fully automated bacteriology system that performs bacterial identification and susceptibility testing analysis using a standard inoculum. It detects resistance and helps combat bacte...
... completely automated instrument that offers Rapid results ... hour same day turnaround), random or batch ... is used for bacterial and yeast identification, ... has a complete data management system. It ...
IDS Rapid Yeast Plus, a microbial identification system....
Medicine Products: