Navigation Links
FDA Advisory Committee Recommends Approval of InterMune's Esbriet(R) (pirfenidone) for Idiopathic Pulmonary Fibrosis
Date:3/9/2010

or information. InterMune's actual results could differ materially from those described in InterMune's forward-looking statements. Pirfenidone failed to achieve statistical significance on the primary endpoint in one of its two pivotal clinical trials and there can be no assurance that the regulatory authorities in either the United States or Europe will grant regulatory approval based upon these data, in combination with the other efficacy analyses and safety results the company has submitted in support of its NDA and MAA filings. 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 16, 2009 (the "Form 10-K"), those additional risks and uncertainties relating InterMune and its business found in the risk factors attached as Exhibit 99.3 to InterMune's Form 8-K filed with the SEC on January 20, 2010, and in the Prospectus Supplement filed with the SEC on January 21, 2010, 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; 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, the Form 8-K, the Prospectus Supplement and InterMune's other periodic reports filed wit
'/>"/>
SOURCE InterMune, Inc.
Copyright©2010 PR Newswire.
All rights reserved

Page: 1 2 3 4 5 6 7 8

Related medicine technology :

1. FDA Advisory Committees Recommend Continued U.S. Marketing Authorization for Trasylol(R)
2. Statement by KCP Chairman Dr. Edward Jones in Response to FDA Advisory Committee on Benefits and Risks of Erythropoietin-Stimulating Agents in Treatment of Kidney Patients
3. Targeted Genetics Reports on Recombinant DNA Advisory Committee (RAC) Review of its Phase 1/2 Trial of tgAAC94 for Rheumatoid Arthritis
4. Schiffrin Barroway Topaz & Kessler, LLP and Janet Jenner & Suggs, LLC Comment on Conagra Advisory Regarding Pot Pies Linked to Salmonella Outbreak
5. Solvay Pharmaceuticals, Inc. Responds to Advisory Committee Recommendation for Further Study of Tedisamil to Treat Atrial Fibrillation
6. FDA Advisory Committee Supports Efficacy and Safety of Zyprexa(R) Long-Acting Injection (LAI) for Schizophrenia Treatment
7. HUYA Bioscience Intl Announces World-Class Clinical Advisory Team for New Anti-Arrhythmic Compound Sourced From China
8. FDA Advisory Committee Unanimously Recommends U.S. Approval of Sugammadex, the First and Only Selective Relaxant Binding Agent
9. Ortho Biotech Statement on U.S. Food and Drug Administration Oncologic Drugs Advisory Committee Vote
10. UBC Forms European Advisory Board to Enhance Data Quality of CNS Trials
11. FDA Advisory Committee Unanimously Recommends Approval of Ustekinumab for Treatment of Moderate to Severe Plaque Psoriasis
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:1/23/2015)... 2015 /PRNewswire/-- Harwood Feffer LLP ( www.hfesq.com ) is investigating ... Inc. ("Advaxis" or the "Company") (NASDAQ: ADXS ... duties to shareholders. On January 21, 2015, ... that Advaxis had misrepresented the clinical data for its ...
(Date:1/23/2015)... , Jan. 23, 2015  HyGreen, Inc., a leader ... and partnership with RCA Medical, a subsidiary of Ascendis ... . Each year, hundreds of millions of ... infections as organisms are transmitted from patient to patient ...
(Date:1/23/2015)... Companies, Inc. (ICBU) has repositioned itself as a holding company ... foothold in the hydroponic, hemp and medical marijuana sectors. By ... the sector, and recently partnering with the Chippewa Tribe Nation ... marijuana, iMD is committing to bring its vision to the ...
Breaking Medicine Technology:Harwood Feffer LLP Announces Investigation of Advaxis, Inc. 2HyGreen Partners with RCA Medical in Johannesburg, South Africa 2iMD Companies Poised to Make Impact in Multi-Billion Dollar Medical Marijuana Sector With Recent Investments and Strategic Partnerships 2
... , BETHESDA, Md. , ... CHDX ), a leading independent American provider of Western,healthcare products and ... the Company plans to release third quarter fiscal year 2010,financial results ... will host a conference call at 8:00 am ET ...
... , RICHMOND, Calif. , ... announced that the company will release its fourth quarter and full year ... market closes. The press release will be followed by a conference call ... public via telephone and webcast. During the conference call, the company will ...
Cached Medicine Technology:Chindex International to Report Third Quarter Fiscal Year 2010 Financial Results 2Chindex International to Report Third Quarter Fiscal Year 2010 Financial Results 3Sangamo BioSciences Announces Fourth Quarter and Full Year 2009 Conference Call and Webcast 2
(Date:1/22/2015)... Chemo Duck Program is pleased to announce the release of the ... with cancer. The Chemo Duck App, available on iTunes for use ... to help children of all ages living with cancer adjust to ... entertained, educated and at ease while waiting for clinic visits or ...
(Date:1/22/2015)... (PRWEB) January 22, 2015 Blue Cross and ... Minnesotans who exemplify what it means to “Live Fearless.” ... for people to share their stories about how they or ... simply inspired others by living in the moment. By telling ...
(Date:1/22/2015)... New York, New York (PRWEB) January 22, 2015 ... filed after Fresenius Medical Care recalled its GranuFlo ... the federal multidistrict litigation underway in U.S. District Court, ... an Order dated January 20th, the Court has remanded ...
(Date:1/22/2015)... York, NY (PRWEB) January 22, 2015 ... College of Sports Medicine flagship journal Medicine & ... with L-Citrulline before exercise may help reduce gastrointestinal ... exercise. 1 , Participants in the double-blind, ...
(Date:1/22/2015)... (PRWEB) January 22, 2015 Payday lending ... vulnerable communities and cause financial distress to the states ... analysts at Howard University’s Center on Race and Wealth. ... in economic activity, payday loans at the same time ...
Breaking Medicine News(10 mins):Health News:Chemo Duck Launches First App Ever Created for Kids with Cancer 2Health News:Chemo Duck Launches First App Ever Created for Kids with Cancer 3Health News:Blue Cross and Blue Shield of Minnesota to Showcase “Faces of Fearless” 2Health News:Court Overseeing Federal GranuFlo Lawsuits Remands Louisiana Claim Back to State Court, Bernstein Liebhard LLP Reports 2Health News:Court Overseeing Federal GranuFlo Lawsuits Remands Louisiana Claim Back to State Court, Bernstein Liebhard LLP Reports 3Health News:Court Overseeing Federal GranuFlo Lawsuits Remands Louisiana Claim Back to State Court, Bernstein Liebhard LLP Reports 4Health News:Study Shows Kyowa Hakko’s L-Citrulline May Help Reduce Gastrointestinal Injury During Strenuous Exercise 2Health News:Study Shows Kyowa Hakko’s L-Citrulline May Help Reduce Gastrointestinal Injury During Strenuous Exercise 3Health News:Howard University Spotlights the Economic Impact of Payday Lending in Southern States 2
... Study Gives Floridians Access to Nursing Home, Assisted Living, Home ... Zip Code StatewideRICHMOND, Va., April 30 The ... a rate outpacing inflation, putting further financial pressure on those ... Genworth Financial. At the same time, the current economic ...
... /PRNewswire-FirstCall/ - Nuvo Research Inc. (TSX: NRI), a Canadian drug ... products that are delivered to and through the skin using ... financial and operational results for the quarter ended March 31, ... - Successfully completed all Pennsaid(R) studies necessary to ...
... PRINCETON, N.J., April 3 In conjunction with its first quarter ... April 29, 2009), Covance Inc. (NYSE: CVD ) is ... call that will be broadcast live over the Internet on Thursday, ... Covance First Quarter 2009 Earnings Webcast and Slide Presentation, ...
... UCLA neurosurgeons will be featured in a documentary for ... will put their skills to the test as they perform ... stepson.TAMPA, Fla., April 30 Two of UCLA,s ... Tumor Awareness Month. Dr. Linda Liau, Professor of neurosurgery and ...
... and book, "Dr. A,s Habits of Health" which is helping thousands ... ... April 30, 2009 -- Dr. Wayne Scott Andersen, a leading critical ... "Dr A,s Habits of Health" will present three free seminars in ...
... Insurance and Student Funding Group team up to ensure international students can ... ... San Jose, CA (PRWEB) April 30, 2009 -- With a rise in ... study, Go One Global (G1G Travel Insurance Services) Corp. has teamed up ...
Cached Medicine News:Health News:Growth in Florida Long Term Care Costs Outpacing the Rate of Inflation, According to Annual Genworth Financial Study 2Health News:Growth in Florida Long Term Care Costs Outpacing the Rate of Inflation, According to Annual Genworth Financial Study 3Health News:Growth in Florida Long Term Care Costs Outpacing the Rate of Inflation, According to Annual Genworth Financial Study 4Health News:Growth in Florida Long Term Care Costs Outpacing the Rate of Inflation, According to Annual Genworth Financial Study 5Health News:Nuvo announces 2009 first quarter financial results 2Health News:Nuvo announces 2009 first quarter financial results 3Health News:Nuvo announces 2009 first quarter financial results 4Health News:Nuvo announces 2009 first quarter financial results 5Health News:Nuvo announces 2009 first quarter financial results 6Health News:Nuvo announces 2009 first quarter financial results 7Health News:Nuvo announces 2009 first quarter financial results 8Health News:Nuvo announces 2009 first quarter financial results 9Health News:Nuvo announces 2009 first quarter financial results 10Health News:Nuvo announces 2009 first quarter financial results 11Health News:Two UCLA Neurosurgeons to Be Showcased in Documentary for the First Official National Brain Tumor Awareness Month 2Health News:Two UCLA Neurosurgeons to Be Showcased in Documentary for the First Official National Brain Tumor Awareness Month 3Health News:Physician and Author to Share Clinically Proven System for Permanent Weight Loss and Optimal Health in Westerville and Dublin, Ohio Areas 2Health News:New G1G Student Medical Insurance and Student Fee Protection Now on StuFund Web Site 2Health News:New G1G Student Medical Insurance and Student Fee Protection Now on StuFund Web Site 3
... ARUP Laboratories is a national reference ... laboratory research and development. ARUP offers an ... unique medical tests in clinical and anatomic ... ARUP Laboratories' clients include more than half ...
... 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 ...
... 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 ...
... 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: