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

he other efficacy analyses and safety results the company has submitted in support of its NDA and MAA filings. Furthermore, while the FDA's PADAC voted 9 to 3 to recommend that the FDA approve pirfenidone to reduce decline in lung function in patients with IPF, because this result is not binding on the FDA and the FDA only considers such recommendation, there can be no assurance that the FDA will ultimately grant such approval upon completion of its review. Factors that could cause or contribute to such differences include, but are not limited to, those discussed in detail under the heading "Risk Factors" in InterMune's most recent annual report on Form 10-K filed with the SEC on March 15, 2010 (the "Form 10-K"), and other periodic reports filed with the SEC, including the following: (i) risks related to the long, expensive and uncertain clinical development and regulatory process, including having no unexpected safety, toxicology, clinical or other issues or delays in anticipated timing of the regulatory approval process; (ii) risks related to failure to achieve the clinical trial results required to commercialize our product candidates, including in particular pirfenidone's failure to achieve statistical significance on the primary endpoint in one of the two CAPACITY trials; and (iii) risks related to timely patient enrollment and retention in clinical trials. The risks and other factors discussed above should be considered only in connection with the fully discussed risks and other factors discussed in detail in the Form 10-K and InterMune's other periodic reports filed with the SEC. InterMune undertakes no duty or obligation to update any forward-looking statements contained in this release as a result of new information, future events or changes in InterMune's expectations.


'/>"/>
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:4/23/2014)... Wash.Researchers at Washington State University Spokane have developed ... about to nod off behind the wheel. , ... wheel movementswhich are more variable in drowsy driversand ... currently available video-based driver drowsiness detection systems. , ... when a car is drifting out of its ...
(Date:4/23/2014)... American Society for Radiation Oncology (ASTRO) has issued ... Therapy for Endometrial Cancer: An ASTRO Evidence-Based Guideline," ... in the treatment of endometrial cancer. The guideline,s ... issue of Practical Radiation Oncology (PRO), ... full-length guideline is available as an open-access article ...
(Date:4/23/2014)... important enzyme pathway that helps prevent new cells from ... that has been directly linked to cancer and other ... that near the end of cell division, the enzyme ... in DNA are fully repaired before the parent cell ... process helps safeguard against some of the most devastating ...
(Date:4/23/2014)... 23, 2014Men whose testosterone falls below normal levels are ... overweight and have heart disease and type 2 diabetes. ... men for further testing and possible treatment is described ... , a peer-reviewed publication from Mary Ann Liebert, Inc., ... Journal of Men,s Health website at http://www.liebertpub.com/jmh ...
(Date:4/23/2014)... (April 23, 2014) The American Gastroenterological Association ... 2014 AGA Research Scholars. The AGA Research Scholar ... to develop independent and productive research careers in ... Awards fund an additional year allowing for three ... to supporting junior faculty who are paving the ...
Breaking Medicine News(10 mins):Health News:WSU innovation improves drowsy driver detection 2Health News:ASTRO issues guideline on the role of postoperative radiation therapy for endometrial cancer 2Health News:ASTRO issues guideline on the role of postoperative radiation therapy for endometrial cancer 3Health News:Study identifies enzymes that help fix cancer-causing DNA defects 2Health News:AGA announces 2014 Class of AGA Research Scholars 2
... Housing NYC,s Homeless & Mentally IllNEW YORK, April 29 ... shed light on it, philanthropic-minded New Yorkers will raise ... the mentally ill and physically disabled. As federal ... health services in the current economy, supporters will raise ...
... the first about his popular cookie-based diet, Dr. Sanford Siegal combines ... history of weight-loss diets through the Ages , ... ... Diet Book (Hyde Park Publishing Ltd., hardcover, 320 pages, ISBN 978-0-9822728-3-1) ...
... Khanna, founder of the Khanna institute of LASIK is Featured ... LASIK, PRELEX and his expanding practice. , ... Westlake, ... of the Khanna Institute of LASIK, was featured in the highly ...
... leader in on-demand workforce development and productivity, announced today that ... staffing, and management, has switched to the LearnCenter platform to ... partners. , ... (PRWEB) April 29, ...
... cleanup from this year,s record floods continue in the Fargo-Moorhead ... providing the city some badly needed good news. Fargo ... cities for ozone pollution, short-term particle pollution and long-term particle ... live in areas that failed all three tests. The rest ...
... strikes, because of severe pain, often accompanied by nausea and ... up to 72 hours. Since they are forced to stop ... subside, migraine causes a significant loss in productivity at work ... especially the 25% of migraineurs who experience more than three ...
Cached Medicine News:Health News:Weston United Celebrates Mental Health Month on May 19th 2Health News:Dr. Siegal's Cookie Diet Book by Sanford Siegal, D.O., M.D., Available May 22nd 2Health News:Dr. Siegal's Cookie Diet Book by Sanford Siegal, D.O., M.D., Available May 22nd 3Health News:Dr. Siegal's Cookie Diet Book by Sanford Siegal, D.O., M.D., Available May 22nd 4Health News:Dr.Khanna Featured in Highly Respected Trade Journal 2Health News:Dr.Khanna Featured in Highly Respected Trade Journal 3Health News:Emergency Consultants Inc. switches to Learn.com to deliver Continuing Medical Education (CME) courses to physicians 2Health News:Emergency Consultants Inc. switches to Learn.com to deliver Continuing Medical Education (CME) courses to physicians 3Health News:Migraine prevention by targeting glutamate receptors? 2Health News:Migraine prevention by targeting glutamate receptors? 3
(Date:1/15/2014)...  Zafgen, Inc., a leading biopharmaceutical company dedicated to ... today announced initial results from its Phase 2a ... aminopeptidase 2 (MetAP2), in patients with Prader-Willi syndrome ... results showed improvements in body weight, hunger-related behaviors, ...
(Date:1/14/2014)... (Nasdaq: LMNX ) today announced that it expects ... Monday, February 3, 2014. A press release announcing the results ... (Logo: http://photos.prnewswire.com/prnh/20100104/LUMINEXLOGO ) Management will ... financial results for the fourth quarter and twelve months ended ...
(Date:1/14/2014)... Dynamic Healthcare Services, Inc. ("DHS"), a portfolio company of GMH ... Medical Equipment, Inc. ("Progressive") of Clarion, PA ... were not disclosed. Progressive is a full ... of sleep, mobility, and respiratory products to customers in the ...
Breaking Medicine Technology:Zafgen Announces Initial Results from Phase 2a Study of Beloranib in Patients with Prader-Willi Syndrome 2Zafgen Announces Initial Results from Phase 2a Study of Beloranib in Patients with Prader-Willi Syndrome 3Zafgen Announces Initial Results from Phase 2a Study of Beloranib in Patients with Prader-Willi Syndrome 4Luminex Corporation Fourth Quarter Earnings Release Scheduled for February 3, 2014 2Luminex Corporation Fourth Quarter Earnings Release Scheduled for February 3, 2014 3Dynamic Healthcare Services Completes Progressive Home Medical Equipment of Clarion, PA Investment 2Dynamic Healthcare Services Completes Progressive Home Medical Equipment of Clarion, PA Investment 3
... (NASDAQ: REGN) today announced that it will report ... April 26, 2012, before the U.S. financial markets open.  The ... that day. Live audio of the conference ... webcast may be accessed from the ,Events and Presentations, page ...
... ST. PAUL, Minn., April 11, 2012 Gamma Pharmaceuticals, ... company focused on alternative delivery systems for everyday ... of a Distribution Agreement with Purchase Order for ... order is for approximately $70,000 retail value.  Gamma ...
Cached Medicine Technology:Gamma Pharmaceuticals, Inc. Announces Distribution Agreement for New York Tri-state Area and Purchase Order for Gamma Energy GEL™ 2Gamma Pharmaceuticals, Inc. Announces Distribution Agreement for New York Tri-state Area and Purchase Order for Gamma Energy GEL™ 3
... Vista 1500 integrated system will ... (integrated multisensor technology) and LOCI ... integrate analysis of electrolytes, general ... drugs, immunosuppressive drugs, plasma proteins, ...
... flexibility to floor-mounted X-ray systems. The ... the C-arm around the exam table ... angle for cardiac and general angiography. ... flat panel detector that delivers outstanding ...
... In-office. Information. In real time. The FemExam pH ... elevated vaginal fluid pH (pH >= 4.7) and ... is easy to use and delivers accurate results ... a swab containing unprocessed vaginal fluid across each ...
The Polygraf ID multi-parametric recorder works with POLYGRAM NET analysis software to create a unique interface that combines web-style navigation, graphical presentation and intuitive design to del...
Medicine Products: