Navigation Links
InterMune Announces Posting of Briefing Documents for FDA Advisory Committee Meeting on Pirfenidone
Date:3/5/2010

ne in lung function.  Pirfenidone has been granted Orphan Drug and Fast Track designation by the FDA, and also has been granted Orphan Drug status in Europe.  On January 4, 2010, InterMune announced that the FDA granted Priority Review designation for the pirfenidone NDA.  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 (PDUFA), the FDA has set an action date for the NDA of May 4, 2010.

On March 2, 2010, InterMune announced that it had submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA), seeking approval to market pirfenidone for the treatment of IPF patients in the European Union.

About Pirfenidone

Preclinical and in-vitro evidence have shown that pirfenidone has both anti-fibrotic and anti-inflammatory effects. In February 2009, InterMune announced the results of the company's two global Phase 3 clinical trials evaluating pirfenidone for the treatment of IPF, known as the CAPACITY trials.  InterMune believes that these data support
'/>"/>

SOURCE InterMune, Inc.
Copyright©2010 PR Newswire.
All rights reserved

Page: 1 2 3 4 5 6 7

Related medicine technology :

1. InterMune Reports Fourth Quarter and Full Year 2009 Financial Results and Business Highlights
2. InterMune to Participate in Pulmonary-Allergy Drugs Advisory Committee Meeting on March 9, 2010
3. InterMune to Present at Deutsche Bank Biotech Confab
4. InterMune Reports Third Quarter 2009 Financial Results and Business Highlights
5. InterMune Announces Submission of NDA for Pirfenidone for the Treatment of Patients with IPF
6. InterMune to Present at JMP Securities Conference
7. InterMune Reports Presentation of Triple Combination Study of ITMN-191 at European Association for the Study of the Liver (EASL)
8. InterMune to Announce Results of Phase 3 CAPACITY Program of Pirfenidone in IPF Tomorrow, February 3
9. InterMune to Conduct Conference Call and Webcast to Discuss Results of Triple Combination Study of ITMN-191
10. InterMune to Report Top-Line Results of Triple Combination Study of ITMN-191 in January 2009
11. Roche, InterMune and Pharmasset Announce Initiation of INFORM-1, the First Dual-Combination Clinical Trial with Oral Antivirals in Hepatitis C
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:3/30/2015)... , 31 mars 2015  Une équipe de ... structure atomique d,un récepteur de surface cellulaire ... formation de thromboses. Contre toute attente, cette ... nouvelles caractéristiques structurelles qui remettent en cause ... sur les récepteurs couplés aux protéines G ...
(Date:3/30/2015)... Va. , March 30, 2015  Researchers ... the Marshall University Joan C. Edwards School of ... entitled, "PSEN1 Variant in a Family with Atypical ... genetically confirmed to have a known variant of ... drug Bryostatin 1. Genetically confirmed Alzheimer,s patients as ...
(Date:3/30/2015)... NEW YORK , March 30, 2015  Check-Cap ... diagnostics company focused on the development of a preparation-free ... screening for colorectal cancer, announced today that its CEO, ... the March 31, 2015 trading day.  Neev and Check-Cap ... to commemorate the company,s initial public offering and simultaneous ...
Breaking Medicine Technology:De nouvelles structures moléculaires remettent en cause les idées conventionnelles concernant l'action des médicaments sur les récepteurs 2De nouvelles structures moléculaires remettent en cause les idées conventionnelles concernant l'action des médicaments sur les récepteurs 3Severe Alzheimer's Patient Responds to Bryostatin Treatment 2Severe Alzheimer's Patient Responds to Bryostatin Treatment 3Severe Alzheimer's Patient Responds to Bryostatin Treatment 4Severe Alzheimer's Patient Responds to Bryostatin Treatment 5Check-Cap to Celebrate Initial Public Offering with NASDAQ Closing Bell Ceremony on March 31, 2015 2Check-Cap to Celebrate Initial Public Offering with NASDAQ Closing Bell Ceremony on March 31, 2015 3
... 2011 Novus Scientific Pte. Ltd today announced that it ... of receiving its anticipated CE Mark approval this year for ... 1st Long-Term Resorbable Synthetic Mesh. To mark the ... 11th 2011 at the Zebrastraat venue in Ghent  ( http://www.novusscientific.com/events/ ...
... Methodist West Hospital (MWH), of West Des Moines, ... Rauland,s new Responder 5 Nurse Call communication system in ... Department (ED) treatment rooms, as well as the Maternity ... wireless phones, MWH created a quiet, healing environment that ...
Cached Medicine Technology:TIGR® Matrix Surgical Mesh - Exhibited Ahead of Anticipated CE Mark Approval at European Hernia Society 2011, Ghent, Belgium 2A Quiet Healing Environment Created by Nurse Call? 2A Quiet Healing Environment Created by Nurse Call? 3A Quiet Healing Environment Created by Nurse Call? 4
(Date:3/31/2015)... 2015 Inspect2go has delivered its ... The software is customized to meet the county’s ... to local food codes. A data connection is ... information on each food establishment in the county is ... Health Department chose Inspect2Go for its innovative tablet design ...
(Date:3/31/2015)... Fairfax, VA (PRWEB) March 31, 2015 The ... in providing members with applied business information and intelligence, has ... to be held June 7-10, 2015, at Caesar’s Palace in ... some of the most profound trends in medical technology, payment ... Chew, president of the RBMA Board of Directors. “This is ...
(Date:3/31/2015)... 31, 2015 Homeowners and landscapers in ... Grass in action and installed in a parking ... of a display plot of Drivable Grass at their ... Grass is a permeable concrete pavement system designed for ... and concrete pavement, Drivable Grass qualifies for several LEED ...
(Date:3/31/2015)... Oakville, ON (PRWEB) March 31, 2015 . ... care and a lot of emphasis is laid upon helping ... breaks the confidence as much as missing teeth and this ... it occurs. The missing teeth not only play a key ... person’s health adversely. , Considering the importance of ...
(Date:3/31/2015)... March 31, 2015 The Buffalo ... peers across the country for distinguished service to its ... New York State Athletic Trainers’ Association (NYSATA) is proud ... these NYS athletic trainers - especially during March as ... Ed Block Courage Award for NFL Athletic Training ...
Breaking Medicine News(10 mins):Health News:Radiology Business Management Association 2015 Radiology Summit Registration Now Open 2Health News:Radiology Business Management Association 2015 Radiology Summit Registration Now Open 3Health News:Super-Sod Recently Completed a Drivable Grass Permeable Paver Demo at their Jacksonville Store 2Health News:NYS Athletic Trainers' Association Congratulates Buffalo Bills Athletic Training Staff for National Award 2Health News:NYS Athletic Trainers' Association Congratulates Buffalo Bills Athletic Training Staff for National Award 3
... Medicine and Allergy, University Hospital, Sweden and his collaborators ... increased inflammation response in the lungs of the exposed ... pathways and openings and when they analyzed the inflammatory ... found a decreased inflammatory cells which they feel is ...
... is a known fact that your race has a ... is a research held at University of Massachusetts// and ... plasma lipids in patients with HIV-1 on HAART (highly ... on 626 patients participating in several ongoing AIDS Clinical ...
... to a NASA analysis. The other warmest years are 1998, ... the year 2005 was reportedly unusually warm. For the purposes ... // stations on land, satellite measurements of sea surface temperature ... ,They found that a strong underlying warming trend ...
... that fish was capable of scaling down the risk of ... do not serve to reduce cancer risk, according to the ... witnessed in the case of people who consume large quantities ... attempted to assess the effects of omega-3 fatty acids on ...
... their National dish ‘Haggis’ had an increased fat diet which ... Scottish people are now facing a high risk of getting ... not have Haggis not more than once in a week. ... from lung, liver and heart of sheep which is mixed ...
... Medicine identify yet another reason to indulge in a vegetarian ... a critical role in the development// of lightweight, yet healthy ... to have a low bone mass. ,The study ... 33 and 85 years, under a strict vegan diet, devoid ...
Cached Medicine News:Health News:Raw Vegan Diet Promises Lightweight, Healthy Bones 2
Shahinian lachrymal cannula, blunt tapered with side port....
West lacrimal cannula, blunt tip, 0.3 mm side opening....
The first easy-to use peroxide system offers proven efficacy that's pure and simple. The convenience of a multi-purpose cleaner/rinse in one bottle. Added power of peroxide in the other bottle....
Graether Collar Button micro iris retractor....
Medicine Products: