Navigation Links
InterMune Announces Receipt of Fast Track Designation for Pirfenidone From FDA
Date:5/19/2008

- Conference call scheduled to discuss Shionogi Phase 3 results on

pirfenidone -

BRISBANE, Calif., May 19 /PRNewswire-FirstCall/ -- InterMune, Inc. (Nasdaq: ITMN) today announced that its program for the development of pirfenidone for the treatment of idiopathic pulmonary fibrosis (IPF) has received "Fast Track" designation from the U.S. Food and Drug Administration (FDA). Fast Track is a designation that the FDA reserves for a drug intended to treat a serious or life threatening condition and one that demonstrates the potential to address an unmet medical need for the condition. The FDA takes appropriate actions to facilitate the development and expedite the review of the approval applications for fast track products.

Dan Welch, Chairman and Chief Executive Officer of InterMune, said, "There are no approved medicines to treat patients who suffer from IPF, a uniformly fatal disease characterized by scarring and inflammation of the lungs. The FDA's action in granting fast track designation is an indication of pirfenidone's potential to address this serious, unmet medical need. We look forward to reporting top-line results of our Phase 3 CAPACITY program of pirfenidone in IPF, in January of 2009."

Webcast and Conference Call on May 20, 5:00 p.m. EDT

InterMune additionally announced that it will conduct a live webcast and conference call on May 20, 2008 at 5:00 p.m. EDT to discuss its Phase 3 CAPACITY program in the context of data that will be presented by Shionogi & Co., Ltd. regarding its Phase 3 trial of pirfenidone in Japan. The Shionogi Phase 3 results are scheduled to be reported in an oral presentation at the meeting of the American Thoracic Society in Toronto at 2:15 p.m.
'/>"/>

SOURCE InterMune, Inc.
Copyright©2008 PR Newswire.
All rights reserved

0

GOOD

Page: 1 2 3

Related medicine technology :

1. InterMune Announces Progress on Pirfenidone in IPF
2. InterMune Provides Additional Information on ITMN-191 (R7227) MAD Study Results
3. InterMune Announces Top-Line Results of Phase 1b Trial of ITMN-191 (R7227) and Provides Program Update
4. InterMune Announces Start of Phase 1b Trial of ITMN-191
5. InterMune Announces Approval of Clinical Trial Authorization for Phase 1b Trial of ITMN-191
6. Ipsogen Announces Three Studies at the American Society of Clinical Oncology (ASCO) Meeting Extending the Utility of the Genomic Grade Index for Predicting Response to Chemotherapy in Breast Cancer
7. TAP Pharmaceutical Products Inc. Announces Phase 3 TAK-390MR Data Demonstrating Higher Overall Healing Versus Lansoprazole in Patients with Erosive Esophagitis
8. Pulmo BioTech Announces Details of the Methodology for its Phase I Human Trials
9. GSK Announces Results of First Phase III Trial Evaluating Tykerb(R) (Lapatinib) Plus Herceptin(R) (Trastuzumab)
10. ADVENTRX Announces ANX-530 Safety Data From Registrational Bioequivalence Clinical Study
11. Medivation Announces Presentation of MDV3100 Clinical Data in Patients With Castration-Resistant Prostate Cancer at 44th American Society of Clinical Oncology Annual Meeting
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:7/23/2008)...ewswire/ -- FluoroPharma Inc., a company developin...sitron Emission Tomography,(PET) market, announced...orine-18 labeled tracer for myocardial perfusion i...lar product to complete Phase I clinical,developme...sess the blood flow in the,heart (myocardial perfu...
(Date:7/23/2008)...23 /- InCode BioPharmaceutics, Inc.,...nced preclinical test,results demonstrating the ut...reatment of the rare chronic blood disorder paroxy...results will be presented at the XXII,Internationa...mber 28,2008., The only treatment currently avai...
(Date:7/23/2008)...ND-Enabling Work with Protein Therapeutics that ... System, CAMBRIDGE, Mass., July 23 /... initiated a corporate growth plan with the,appoin... officer and the,establishment of its headquarters...f Emlen, M.D., a co-founder of the company who rem...
(Date:7/22/2008)...sults from a multi-center 293-patient European, t... Exchange Symbol: CYT, MONTREAL, July 22 /PRNewsw...e global leader in cryotherapy products to treat c...reviously presented from three,European study cent...(R),were published earlier today in the Journal o...
Breaking Medicine Technology:FluoroPharma Announces Positive Phase I Safety Results for BFPET(TM), Myocardial Perfusion Imaging (MPI) Tracer for Positron Emission Tomography (PET) 2FluoroPharma Announces Positive Phase I Safety Results for BFPET(TM), Myocardial Perfusion Imaging (MPI) Tracer for Positron Emission Tomography (PET) 3InCode BioPharmaceutics, Inc. Announces Key Data Supporting New Treatment of Paroxysmal Nocturnal Hemoglobinuria (PNH) 2Taligen Therapeutics Initiates Corporate Growth Plan with Appointment of Abbie Celniker, Ph.D., as CEO and Establishment of Cambridge, Mass., Headquarters 2Taligen Therapeutics Initiates Corporate Growth Plan with Appointment of Abbie Celniker, Ph.D., as CEO and Establishment of Cambridge, Mass., Headquarters 3CryoCath Arctic Front(R) Results Published in JACC 2CryoCath Arctic Front(R) Results Published in JACC 3Access Highlighted in Recent BusinessWeek Article 498 1Access Highlighted in Recent BusinessWeek Article 498 2Prescription labels geared toward pharmacies not patients 982 1Prescription labels geared toward pharmacies not patients 982 2Scientists fear rare dolphin driven to extinction by human activities 345 1Scientists fear rare dolphin driven to extinction by human activities 345 2IVCC launches groundbreaking insecticide projects with Bayer and Syngenta 978 1IVCC launches groundbreaking insecticide projects with Bayer and Syngenta 978 2
(Date:7/25/2008)...ncial results -, LAVAL, QC, July 25 /PRNewswire-F...) today announced that it will host a conference c...ss its second quarter 2008,financial results. Labo...l,results via news release at approximately 7:00 a...by telephone, dial 416-646-3095 or,1-800-814-4859....
(Date:7/25/2008)...stCall/ -- Thoratec,Corporation (Nasdaq: THOR ) a...ry support therapies to save, support and restore ...t its operating results for the second,quarter and... 31., The company will hold a conference call to ...ties to all interested parties at 1:30 p.m.,Pacif...
(Date:7/25/2008)...unction, increases asthma risk, studies find, ,... clean, fresh-smelling home may actually be bad fo...and air freshening products you use. , Recent r...s or air fresheners that contain a certain volatil...ne (1,4 DCB), can reduce lung function by 4 percen...
(Date:7/25/2008)... Society for Gastrointestinal Endoscopy (ASGE) has... bariatric surgery patient. The rising prevalence ... surgical interventions led to a marked increase i... the U.S., from 13,365 in 1998 to 102,794 in 2003....ive patient and the postoperative patient, and app...
Breaking Medicine News(10 mins):Health News:Labopharm to host conference call Friday, August 8, 2008 at 8:30 A.M. (ET) 2Health News:Thoratec Schedules Second Quarter 2008 Conference Call, Webcast 2Health News:Health Hazards in Household Cleaners Exposed 2Health News:Health Hazards in Household Cleaners Exposed 3Health News:ASGE issues guidelines on the role of endoscopy in the bariatric surgery patient 2Health News:ASGE issues guidelines on the role of endoscopy in the bariatric surgery patient 3
...nder affects learning have found that boys and gir...rent ways. However, they have suggested that thi...er their kids from co-educational to segregated sc...American educator Michael Gurian, at a conference ...
...co will kill a billion people this century, 10 tim... unless the countries take serious action to preve...re assuming that by putting one cigarette to your ...if you sniff-up someone else's smoke only once, yo...
...first manned mission to Mars, it has taken its fir...o you get rid of the body of a dead astronaut on a...the plug be pulled on a critically ill astronaut w...ngering the rest of the crew? Should NASA employ D...
...reveals the war veterans who have come back after ...nt. Due to the exposure to chemicals and other har...o brain regions that are closely linked to learnin...of the department of environmental health at the B...
Other Medicine News:Health News:Boys and Girls are Different by Nature and Learn in Different Ways 2Health News:1 Billion People to Be Killed by Smoking 2Health News:NASA Gets Ready To Address Tough Questions 2Health News:NASA Gets Ready To Address Tough Questions 3Health News:Gulf War Veterans Exhibit Memory Impairment 2
... IOL power calculation software. All A-scans and A...e module with SRK II, SRKT, Holladay Dioptimum and...H 5100e are equipped with corneal compression dete...eadings. The only A-Scan in the world with corneal...
The AccuSonic A-scan makes it easy to obtain extreme accuracy and improved patient outcomes. Obtain accurate measurements with industry leading signal acquisition and processing.
The UD-1000 incorporates the latest ultrasound technology for eyecare specialists. It is the ideal choice for your modern diagnostic laboratory. The UD-1000 combines a powerful B-sector scan system w
The UD-6000 combines all the functions of modern ultrasound diagnostics used in ophthalmology: The latest generation high resolution A/B-sector scanner, a diagnostic A-mode scanner with an optional p
Medicine Products: