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

BRISBANE, Calif., March 23 /PRNewswire-FirstCall/ -- InterMune, Inc. (Nasdaq: ITMN) today announced that the company's Marketing Authorization Application (MAA), submitted on March 2 seeking approval of pirfenidone for the treatment of idiopathic pulmonary fibrosis (IPF) in adults, was validated by the European Medicines Agency (EMA). Validation of the MAA by the EMA indicates that the application is complete and that the review process will begin on March 24. The proposed trade name for pirfenidone in both the United States and Europe is Esbriet®.

IPF is a rare and fatal lung disease that affects approximately 200,000 people in the United States and Europe combined. If approved by the EMA, pirfenidone would be the first medication to be made available to IPF patients in the European Union. Pirfenidone was approved for marketing in Japan in October of 2008 and is marketed as Pirespa® by Shionogi & Co. Ltd.

Pirfenidone has been granted Orphan Drug designation in Europe. If approved by the EMA, InterMune intends to commercialize pirfenidone independently in Europe an
'/>"/>

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:8/30/2014)... "My wife suffered neck, back and spine injuries ... of two inventors from Bethel, Alaska. "The whiplash contributed ... area. She tried other pillows to little avail. The ... comfort and providing extra sleep." , They created a ... head, neck and back comfortably. This enables the user ...
(Date:8/30/2014)... 30, 2014 "My niece developed a ... at any moment, her fever might get worse," said ... me well aware of how she was doing, I ... ALARM to continuously monitor a child's temperature. The unit ... This ensures that prompt medical care can be given, ...
(Date:8/30/2014)... York (PRWEB) August 30, 2014 ... transvaginal mesh lawsuits ( http://www.injurybeacon.com/transvaginal-mesh/ ) filed against ... to sever four cases selected for one of ... issued on August 18, 2014, U.S. District Judge ... West Virginia disagrees with Boston Scientific’s contention that ...
(Date:8/30/2014)... In today’s world, a good night’s sleep has become especially ... (a medical problem where the airway collapses during sleep and ... rest they need to face their daily challenges. , ... people in the United States alone have sleep apnea. Of ... those treated, many cannot tolerate their prescribed medical device known ...
(Date:8/30/2014)... August 30, 2014 Top10BestSEOHosting.com is ... researchers have announced that HostGator.com http://secure.hostgator.com/~affiliat/cgi-bin/affiliates/clickthru.cgi?id=seohosts ... current market. Also, they has announced that Bluehost ... , Hostgator, one of the Top 10 ... of cheap Windows hosting, and it offers rich ...
Breaking Medicine News(10 mins):Health News:Transvaginal Mesh Lawsuit News: Federal Judge Refuses Boston Scientific Request for Separate Trials in Four Bellwether Cases, Bernstein Liebhard LLP Reports 2Health News:Transvaginal Mesh Lawsuit News: Federal Judge Refuses Boston Scientific Request for Separate Trials in Four Bellwether Cases, Bernstein Liebhard LLP Reports 3Health News:Snoring: Bad for Relationships, Bad for Health 2Health News:Snoring: Bad for Relationships, Bad for Health 3Health News:Top10BestSEOHosting.com: HostGator.com Is The Best Windows Hosting Supplier 2
... CORONA, Calif., July 25 Watson,Pharmaceuticals, Inc. ... announced today that its subsidiary has commenced commercial,shipment ... the 40mg,strength from its Davie, Florida manufacturing facility. ... of marketing exclusivity for being the,first to file ...
... to benefit ALS Therapy Alliance to be presented at Fenway Park ... ... CVS/pharmacy announced today,that this year it has raised a record-breaking $4.4 ... research. This is,the seventh year of the annual fundraising effort which, to ...
... of New York will present an educational meeting regarding age-related macular ... the Farmingdale Public Library at 116 Merritts Road, Farmingdale, NY 11735, ... and refreshments will be provided. The phone number for pre-registration is ... ...
... at Wake Forest University Baptist Medical Center have disproved ... slows or stunts the immune system,s ability to restore ... of drugs known as the "cocktail." , Hepatitis ... leading to rapid liver damage, according to the Centers ...
... Experience it ... Are you an e-patient?,Studies show that 80 percent ... to Web 2.0, e-patients now have even more ways,to ... learn about,advanced medical technologies. Go to http://SutterHealth.org/annualreport ,and ...
... 24 AMICAS, Inc. (Nasdaq: AMCS ),a leader in ... will report the company,s financial results,for the second quarter ending ... 2008., (Logo: http://www.newscom.com/cgi-bin/prnh/20060202/AMICASLOGO ... Tuesday, August 5, 2008 -- Call begins ...
Cached Medicine News:Health News:Watson Launches Omeprazole Delayed-Release Capsules, 40MG 2Health News:CVS/pharmacy Raises Record-breaking $4.4 Million for ALS Research Through Annual ALS Fundraising Campaign 2Health News:Retina Group of New York To Present Seminar on Age-Related Macular Degeneration; The Leading Cause of Visual Loss in Seniors 2Health News:Retina Group of New York To Present Seminar on Age-Related Macular Degeneration; The Leading Cause of Visual Loss in Seniors 3Health News:Researchers disprove long-standing belief about HIV treatment 2Health News:Researchers disprove long-standing belief about HIV treatment 3Health News:Internet Video Revolution - Sutter Health Harnesses Power of Web 2.0 to Inform Customers 2Health News:Internet Video Revolution - Sutter Health Harnesses Power of Web 2.0 to Inform Customers 3Health News:Internet Video Revolution - Sutter Health Harnesses Power of Web 2.0 to Inform Customers 4Health News:AMICAS Schedules Second Quarter Earnings Call 2
(Date:8/29/2014)... 2014 Medina Medical announced today that Mr. ... the Board of Directors on August 18, 2014. Mr. ... commercialization experience, including over a decade of direct experience ... a Partner of the medical device incubator The Foundry, ... Foundry start-ups. Mr. Engelson previously served as the Chief ...
(Date:8/29/2014)... 29, 2014 Research and Markets ... Cancer Therapeutics Market & Pipeline Insight 2014" report ... developed to prevent and eradicate the prevalence of cancer ... are confined to low specificity, safety and large number ... for a better solution. It has been discovered that ...
(Date:8/29/2014)... -- Research and Markets has announced the ... of Pharmaceutical Equipment Market in China, 2014-2018" report ... Trend Forecast of Pharmaceutical Equipment Market in ... pharmaceutical equipment industry in the aspects of ... business performance of domestic major enterprises, as well as ...
Breaking Medicine Technology:Medina Medical Announces Erik T. Engelson Joins as Chief Executive Officer 2Global Peptide Cancer Therapeutics Market & Pipeline Insight 2014 2Research and Development Trend Forecast of Pharmaceutical Equipment Market in China, 2014-2018 2
... , , LAKE FOREST, Ill. ... leading developer and manufacturer of injectable pharmaceuticals announced today ... of Corvert ® from Pfizer Inc. , (Logo: ... Injection further demonstrates Bioniche Pharma,s continued growth and dedication ...
... CHARLOTTESVILLE, Virginia , January ... and Drug Administration (FDA) has licensed its,technology platform to help ... harmful side effects. , The FDA,s ... Research (CDER), will test the use of Biovista,s Adverse Event,Analysis ...
Cached Medicine Technology:Bioniche Pharma Launches Ibutilide Fumarate Injection 2Biovista Inc. and FDA to Collaborate on a Medication Safety Initiative 2
... reference laboratory and a worldwide leader in ... an extensive test menu of highly complex ... anatomic pathology. Owned by the University of ... half of the nation's university teaching hospitals ...
... national reference laboratory and a worldwide leader ... offers an extensive test menu of highly ... and anatomic pathology. Owned by the University ... than half of the nation's university teaching ...
... national reference laboratory and a worldwide leader ... offers an extensive test menu of highly ... and anatomic pathology. Owned by the University ... than half of the nation's university teaching ...
... Laboratories is a national reference laboratory and ... and development. ARUP offers an extensive test ... tests in clinical and anatomic pathology. Owned ... clients include more than half of the ...
Medicine Products: