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:1/14/2014)... , Jan. 14, 2014 The Brandeis Medical Center, led by ... a premier and affordable laser tattoo removal experience with the ... focus is in providing high quality cosmetic services with cutting edge ... " Southern California has seen a dramatic ...
(Date:1/14/2014)... Jan. 14, 2014 /PRNewswire-iReach/ -- Acumed,s new SLIC Screw ... with accompanying instrumentation to place and insert the screw ... soft tissue (e.g. ligament) repair or reconstruction as it ... (Photo: http://photos.prnewswire.com/prnh/20140114/MN45636 ) ...
(Date:1/14/2014)... 14, 2014   NuAire , a manufacturer of ergonomically designed ... Hitachi Koki of Japan to sell ... America . NuAire will utilize its network of sales professionals ... Canada to offer assistance in application use, product benefits ...
Breaking Medicine Technology:Beverly Hills Physician Features Tattoo Removal with the Astanza Duality Laser, Offers $99 Special 2Acumed introduces the Scapho-Lunate Inter Carpal (SLIC) Screw System 2Acumed introduces the Scapho-Lunate Inter Carpal (SLIC) Screw System 3NuAire announces sales and service of Hitachi Koki centrifuges in North America 2
... Arena Pharmaceuticals, Inc. (NASDAQ: ARNA ) today reported ... "We view the results from the Pathology Working ... our planned response to the lorcaserin complete response letter," stated ... working to complete the remaining activities in order to submit ...
... 9, 2011 Enobia Pharma Inc., a clinical stage ... bone disorders, today announced that it has raised US ... shares of its common stock to new pharmaceutical and ... the ongoing development of ENB-0040, Enobia,s enzyme replacement therapy ...
Cached Medicine Technology:Arena Pharmaceuticals Announces Second Quarter 2011 Financial Results 2Arena Pharmaceuticals Announces Second Quarter 2011 Financial Results 3Arena Pharmaceuticals Announces Second Quarter 2011 Financial Results 4Arena Pharmaceuticals Announces Second Quarter 2011 Financial Results 5Arena Pharmaceuticals Announces Second Quarter 2011 Financial Results 6Arena Pharmaceuticals Announces Second Quarter 2011 Financial Results 7Enobia Pharma Raises US $40 Million 2
(Date:4/17/2014)... non-cancerous prostate tissue may have nearly twice the risk ... inflammation, according to results of a new study led ... , The link between persistent inflammation and cancer was ... those with a Gleason score between 7 and ... and rapidly growing prostate cancers. , "What we,ve shown ...
(Date:4/17/2014)... today in PLOS Pathogens , children who live ... can mount an immune response to infection with malaria ... of high fever and illness and partially control the ... may help researchers develop future interventions that prevent or ... Each year, approximately 200 million cases of malaria occur ...
(Date:4/17/2014)... in the April issue of Immunity , Kevin ... Medical Research, says it,s time to take a fresh ... sepsis, which kills millions worldwide every year, including ... released into the bloodstream to fight an injury or ... for maintaining good health without inflammation, wounds and ...
(Date:4/17/2014)... MAYWOOD, Il. (April 17, 2014) Doctors who ... disease called lymphangioleiomyomatosis (LAM) can face an agonizing ... progression of the disease and help relieve shortness ... lung transplants, and sirolimus can cause potentially fatal ... said pulmonologist Dr. Daniel Dilling, medical director of ...
(Date:4/17/2014)... By discovering a new mechanism that allows blood to ... UC Irvine and the Salk Institute have opened the ... stroke-induced brain damage. , A complex and devastating neurological ... primary reason for disability in the U.S. The blood-brain ... blood-borne material into the brain, causing the permanent deficits ...
Breaking Medicine News(10 mins):Health News:Chronic inflammation linked to 'high-grade' prostate cancer 2Health News:Chronic inflammation linked to 'high-grade' prostate cancer 3Health News:Study sheds light on how the immune system protects children from malaria 2Health News:Feinstein Institute researcher publishes new perspective on sepsis 2Health News:Patients with rare lung disease face agonizing treatment dilemma 2Health News:Patients with rare lung disease face agonizing treatment dilemma 3Health News:Study IDs new cause of brain bleeding immediately after stroke 2
... EAST LANSING, Mich. - With the help of a ... Michigan State University is creating a cross-discipline, mentored program ... in women,s health., MSU,s new Building Interdisciplinary Research Careers ... Department of Medicine in the College of Human Medicine, ...
... MD, MPH, an endocrinologist at Nationwide Children,s Hospital, has ... customized text messages to remind adolescent diabetes patients about ... study, Dr. Dyer found an increase in overall treatment ... Dyer began developing this pilot study after realizing the ...
... , THURSDAY, July 29 (HealthDay News) -- Although millions ... ward off osteoporosis, New Zealand researchers say the supplements have ... increase in the risk for heart attack among older people. ... suggest that people get their required calcium, if possible, from ...
... is a protein that is expressed in and on ... and antigen presenting cells. This protein is known for ... response. Additionally, Professor Shachar,s lab has previously shown that ... the immune system, and that its stimulation by its ...
... influencing both morbidity and recovery after surgery. The ... intervention, which may prevent later complications. A traditional ... to identify significant weight loss over time, significantly ... nutritional factor levels and functional measurements of muscle ...
... most common cancers worldwide, particularly in China. However, ... to treat. It is important to screen for ... possess anti-cancer properties. These dietary compounds may modify ... proliferation and apoptosis. Galangin could inhibit the methoxyresorufin ...
Cached Medicine News:Health News:MSU targets women's health research with $2.5 million grant 2Health News:Pilot study supports adolescent diabetes patients through personalized text messages 2Health News:Calcium Supplements Linked to Boost in Heart Attack Risk 2Health News:Calcium Supplements Linked to Boost in Heart Attack Risk 3Health News:Calcium Supplements Linked to Boost in Heart Attack Risk 4Health News:How to detect malnutrition in patients effectively? 2
... MonoPrep LBP Processor is a primary component ... collection, accessioning, processing, sampling, and slide preparation ... management. The MonoPrep LBP Processor produces high-quality ... a broad range of cytology specimen types. ...
... quick and easy automated refill system ... space on your laboratory bench and ... easy-to-use, one-hand system, you only need ... of Diamond Tips. All sizes of ...
200 L, Racked, Pre-sterilized, 96 tips/rack, clear Recommended for 20, 25, 50, 100 and 200 L pipettes. Can also be used with 300 L pipettes when pipetting 200 L or less....
MBP's equivalent to the "Universal Yellow" tip, this 200 L tip utilizes a MicroPoint design for accurate sample handling. 10 L Ref. mark....
Medicine Products: