Navigation Links
InterMune Reports Second Quarter 2014 Financial Results and Business Highlights
Date:8/6/2014

s and our anti-fibrotic research programs."

Recent Business and Clinical Development Highlights

  • On July 17, 2014, InterMune reported that pirfenidone had been granted Breakthrough Therapy Designation by the FDA.  This designation is reserved for drugs that are intended to treat a serious or life threatening disease or condition and for which preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints.  According to the FDA Fact Sheet: "If a drug is designated as breakthrough therapy, FDA will expedite the development and review of such drug."
  • InterMune today reported that the FDA has informed the company that at this time, the agency does not plan to convene an advisory committee for pirfenidone.
  • On July 10, 2014, InterMune submitted to the European Medicines Agency (EMA) a variation to the Esbriet marketing authorization.  The purpose of the variation is to update the Summary of Product Characteristics (SmPC) to include the ASCEND clinical data.  InterMune anticipates receiving a decision on the proposed variation from the EMA in early 2015. 
  • At the International Conference of the American Thoracic Society (ATS) in May 2014, data from the Phase 3 ASCEND trial of pirfenidone in IPF were presented.  The ATS presentation included data and additional supportive analyses demonstrating the treatment effect of pirfenidone on Forced Vital Capacity (FVC) change and other important clinical endpoints, including mortality.  Additionally, the data demonstrated a favorable safety and tolerability profile of pirfenidone in ASCEND that was generally consistent with observations from the previous Phase 3 CAPACITY studies, open-label extension studies and post-marketing experience.  Simultaneous with its presentation at ATS, the results of ASCEND were published in the New England Journal o
    '/>"/>

  • SOURCE InterMune, Inc.
    Copyright©2014 PR Newswire.
    All rights reserved

    Page: 1 2 3 4 5 6 7 8 9 10 11 12 13 14

    Related medicine technology :

    1. The Zacks Analyst Blog Highlights: Anthera Pharmaceuticals, Amgen, Eli Lilly, Actelion and InterMune
    2. InterMune Announces Proposed Public Offering of Common Stock
    3. InterMune Reports Second Quarter 2013 Financial Results And Business Highlights
    4. Sean P. Nolan Joins InterMune as Executive Vice President and Chief Business Officer
    5. InterMune Announces Presentations of New Research in IPF at ERS
    6. InterMune Reports Second Quarter 2012 Financial Results and Business Highlights
    7. InterMune to Divest Actimmune® (Interferon Gamma-1b)
    8. Neurocrine Biosciences Reports Second Quarter 2014 Results
    9. Biosensors Reports Financial Results for the First Quarter of Fiscal Year 2015
    10. China Biologic Reports Financial Results for the Second Quarter of 2014
    11. Avanir Pharmaceuticals Reports Fiscal 2014 Third Quarter Financial and Business Update
    Post Your Comments:
    *Name:
    *Comment:
    *Email:
    (Date:12/24/2014)... -- The International Trade Commission (ITC) issued its final decision in ... a notice issued on December 23, the ITC ruled in ... humidifier was invalid. BMC President, James Xu ... excited with the ITC,s decision in this case. This victory ... the very beginning on the key patents in the case. ...
    (Date:12/24/2014)... 24, 2014  Diplomat Pharmacy, Inc. (NYSE: ... proud to announce Jennifer Hagerman , Pharm.D., AE-C, ... take office as the president of the Michigan Pharmacists ... will take place Feb. 28, 2015, at the MPA ... the Renaissance Center in Detroit, Michigan ...
    (Date:12/24/2014)... LONDON , December 24, 2014 ... grow at an average rate of 8.1%. The US ... Hip, knee and spine surgeries are the common orthopedic ... they have a lower penetration. Increased number of product ... composites. Non-metallic orthopedic devices have gained popularity in the ...
    Breaking Medicine Technology:ITC Final Decision Goes Against ResMed (RMD) Monumental Win for 3B/BMC 2Diplomat's senior director of education and quality to be inducted as 2015 president of the Michigan Pharmacists Association 2Diplomat's senior director of education and quality to be inducted as 2015 president of the Michigan Pharmacists Association 3Use of Composites in Orthopedic Industry to Reach $596 Million by 2020 2Use of Composites in Orthopedic Industry to Reach $596 Million by 2020 3
    ... EGFR / HER2 Tyrosine Kinase Inhibitor, Suggests Activity in ... - (1,2)-The First Presentation of Data on BIBF 1120 ... will present new data on the company,s two lead ... 2009 Annual Meeting of the American Society of Clinical ...
    ... (Nasdaq: SPEX ), an innovator in ... technical and regulatory consulting services to food, supplement, ... May 12, 2009, its Board of Directors elected ... begin serving immediately. Mr. Peter will also ...
    Cached Medicine Technology:Boehringer Ingelheim to Present New Phase II Clinical Data on Two Lead Oncology Compounds at ASCO 2009 2Boehringer Ingelheim to Present New Phase II Clinical Data on Two Lead Oncology Compounds at ASCO 2009 3Boehringer Ingelheim to Present New Phase II Clinical Data on Two Lead Oncology Compounds at ASCO 2009 4Boehringer Ingelheim to Present New Phase II Clinical Data on Two Lead Oncology Compounds at ASCO 2009 5Boehringer Ingelheim to Present New Phase II Clinical Data on Two Lead Oncology Compounds at ASCO 2009 6Boehringer Ingelheim to Present New Phase II Clinical Data on Two Lead Oncology Compounds at ASCO 2009 7Boehringer Ingelheim to Present New Phase II Clinical Data on Two Lead Oncology Compounds at ASCO 2009 8Boehringer Ingelheim to Present New Phase II Clinical Data on Two Lead Oncology Compounds at ASCO 2009 9Boehringer Ingelheim to Present New Phase II Clinical Data on Two Lead Oncology Compounds at ASCO 2009 10Spherix Elects New Independent Director, and Elects Chairman of the Board 2Spherix Elects New Independent Director, and Elects Chairman of the Board 3
    (Date:12/25/2014)... 25, 2014 Recently, BellasDress ... all its wedding dresses. BellasDress has chosen their best-selling ... gift choices for the holiday season. , Now, ... suitable wedding gowns here at discount prices. The business ... at its website. , “All our elegant ...
    (Date:12/25/2014)... Helen Harris’ RP (Retinitis Pigmentosa) International founder ... an 8 year battle with breast cancer. , ... her home in Woodland Hills California after an 8 ... , As the founder and volunteer President of ... championed many of today's greatest breakthroughs in restoring and ...
    (Date:12/25/2014)... Recently, LunaDress.co.uk has updated its blog to provide professional ... all of the models at LunaDress.co.uk come with big discounts, up ... wedding veil can turn out to be a most exciting memory ... can always bring surprise to a wedding. On the updated fashion ... choose veils for a big day . , Going out with ...
    (Date:12/25/2014)... The risk of burns from fires and cooking accidents ... extra cautious, an expert says. "Between Thanksgiving and ... patients coming in with burns," said Dr. Steven Sandoval, ... Center of Stony Brook University Hospital in New York. ... if not careful, could quickly turn tragic," Sandoval said ...
    (Date:12/25/2014)... 24, 2014 (HealthDay News) -- Among early stage breast ... than half of one percent will eventually develop leukemia ... reveals. The finding comes from a review of ... and 2007, and it suggests that the risk for ... experts had previously thought. "The frequency of bone ...
    Breaking Medicine News(10 mins):Health News:BellasDress.com’s Christmas Sale: Trendy Wedding Dresses With Big Discounts 2Health News:RP International founder, Helen Harris Dies on Christmas Eve Just Hours Before Her Holiday Television Broadcast to Raise Funds to Cure Blindness was Broadcasted Nationally 2Health News:RP International founder, Helen Harris Dies on Christmas Eve Just Hours Before Her Holiday Television Broadcast to Raise Funds to Cure Blindness was Broadcasted Nationally 3Health News:RP International founder, Helen Harris Dies on Christmas Eve Just Hours Before Her Holiday Television Broadcast to Raise Funds to Cure Blindness was Broadcasted Nationally 4Health News:LunaDress Provides Professional Tips On Shopping Wedding And Prom Dresses 2Health News:Don't Let Burns Mar Your Holidays 2Health News:Breast Cancer Chemo Tied to Small But Significant Leukemia Risk 2Health News:Breast Cancer Chemo Tied to Small But Significant Leukemia Risk 3
    ... AMERIGROUP,Corporation (NYSE: AGP ) today announced that ... Conference on November 13 in Phoenix,Arizona., A live ... at 4:00 p.m. Eastern Time, can be accessed on ... A replay will,be available for 30 days, and can ...
    ... LOS ANGELES, Oct. 30 Members of SEIU ... collective bargaining,agreements that will make improvements for hundreds ... several California nursing homes., In all, seven ... wage increases of $1.50/hr over three years, employer ...
    ... age of disease onset and nerve cell death , , ... genes may be linked to the most common form ... team, from Massachusetts General Hospital-MassGeneral Institute for Neurological Disease ... families with a history of the devastating neurological disorder. ...
    ... Medical, Inc.,(Nasdaq: ATSI ), manufacturer and marketer ... it has received U.S. Food,and Drug Administration (FDA) ... http://www.newscom.com/cgi-bin/prnh/20040202/ATSILOGO ), This is the Company,s ... market. Based on the precept that ,Form Follows ...
    ... WellPoint,s commercial marketing,team was awarded a silver ... its innovative campaign, "Ecosphere -- Simple is more ... Awards competition is the only international,award that honors ... response results., WellPoint,s campaign, conducted through its ...
    ... AGA Medical Holdings ("AGA,Medical", "AGA") announced today its ... Court in the Netherlands related to a proceeding,brought ... lawsuit,sought invalidity and/or non-infringement declarations related to AGA,Medical,s ... its European patents,for intravascular occlusion devices and the ...
    Cached Medicine News:Health News:Scientists Spot 4 New Alzheimer's Genes 2Health News:ATS Medical Announces FDA Approval of the ATS 3f Aortic Bioprosthesis 2Health News:ATS Medical Announces FDA Approval of the ATS 3f Aortic Bioprosthesis 3Health News:ATS Medical Announces FDA Approval of the ATS 3f Aortic Bioprosthesis 4Health News:WellPoint Awarded Prestigious International Marketing Award 2Health News:AGA Medical to Appeal Ruling by Dutch Court in Lawsuit With Occlutech GmbH 2
    ... 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 ...
    ... a national reference laboratory and a worldwide ... ARUP offers an extensive test menu of ... clinical and anatomic pathology. Owned by the ... more than half of the nation's university ...
    ... ARUP Laboratories is a national reference laboratory ... research and development. ARUP offers an extensive ... medical tests in clinical and anatomic pathology. ... Laboratories' clients include more than half of ...
    ... 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 ...
    Medicine Products: