Navigation Links
FDA Advisory Committee Recommends US Approval of Novartis Once-daily Bronchodilator QAB149 for COPD
Date:3/8/2011

al program supporting US submission evaluated safety in 4,764 patients who received QAB149 for at least 12 weeks at doses of 75 mcg and greater, with results supporting the safety and tolerability profile of QAB149. The most commonly reported adverse events with both the 75 and 150 mcg doses were worsening of COPD, nasopharyngitis, cough, and headache.

"We must intensify our efforts to increase awareness, prevention and detection, and to develop new treatments to help reduce the enormous burden COPD places on patients, their families and our healthcare system," said John W. Walsh, president and co-founder of the US-based COPD Foundation. "Deaths from COPD are increasing much faster than previously projected, which should be a wake-up to all of us."

QAB149 is approved at 150 and 300 mcg once-daily doses in more than 50 countries worldwide under the brand-name Onbrez® Breezhaler®. Altogether, the clinical trial program for QAB149 involved more than 15,000 people of whom 9,243 were given QAB149 at varying doses and assessed for safety.

In the US, Novartis is seeking approval for the use of QAB149 as a once-daily long-term maintenance bronchodilator treatment for airflow obstruction in patients with COPD, including bronchitis and/or emphysema. Novartis is not seeking an indication for asthma. If approved in the US, the proposed brand name will be Arcapta™ Neohaler™.

COPD, a progressive and life-threatening lung disease making it difficult to breathe, affects more than 12 million people in the US, while another 12 million people are estimated to have the disease but are undiagnosed. COPD ranks as the third leading cause of death in the US and is a major cause of serious long-term disability.

Disclaimer

The foregoing release contains forward-looking statements that can be identified by terminology such as "recommends," "recommended," "recommending," "recommendation," "recommendations,"  "commit
'/>"/>

SOURCE Novartis Pharmaceuticals Corporation
Copyright©2010 PR Newswire.
All rights reserved

Page: 1 2 3 4

Related biology technology :

1. Myriant Technologies, Inc. Announces J. Brian Ferguson to Join Advisory Board
2. Sensus Healthcare Announces the Formation of a Medical Advisory Board
3. Max Neeman International Initiates Advisory Committee to Advance and Improve the Conduct of Complex Neurological Trials in India
4. Leading Dental Stem Cell and Regenerative Medicine Researcher Dr. George Huang Joins StemSaves Science Advisory Council
5. Carl A. Miller, PhD, Joins iDiverses Business and Scientific Advisory Board
6. Dr. Russell L. Chapman Joins Aquatic Energy as the Chairman of its Science Advisory Board
7. Chimerix Presents Update on CMX001 Development to the World Health Organization Advisory Committee on Variola Virus Research
8. IGEN Networks Corp continues to build a world class advisory board, with the appointment of three new members
9. IGEN NETWORKS ANNOUNCES THE APPOINTMENT OF TWO NEW MEMBERS TO THE ADVISORY BOARD
10. Regenicin Appoints Renowned New York Dermatologist, Dr. Gervaise Gerstner to Scientific Advisory Board
11. Signal Genetics Announces Establishment of Scientific Advisory Board
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:7/29/2015)... , July 30, 2015 ... la santé, publie ses résultats pour le premier ... commente les résultats. Visionner l,interview ... http://www.eurobusinessmedia.com/ceo-direct/sanofi/sanofi-h1-2015-results-interview-with-ceo-olivier-brandicourt?utm_source=ceo-direct&utm_medium=wire Au sommaire de ... - Moteurs de croissance - ...
(Date:7/29/2015)... Ala., July 29, 2015  HealthSouth ... nation,s largest providers of post-acute healthcare services, offering ... its results of operations for the second quarter ... quarter was characterized by strong volume growth in ... Adjusted EBITDA," said Jay Grinney, President and Chief ...
(Date:7/29/2015)... July 29, 2015  AmnioChor Inc., an early stage ... very pleased to announce that the Musculoskeletal Transplant Foundation ... to invest in their seed round of development of ... storage capabilities. AmnioChor,s technology allows cryopreservation ... human stem cells living within those tissues. Amnion is ...
(Date:7/29/2015)... 29, 2015 /PRNewswire/ - RepliCel Life Sciences Inc. (OTCQB: ... company, is pleased to announce that the final design ... been locked.  Prototypes for industrial and regulatory testing ... application for CE mark clearance to market the ... 2016. (Photo: http://photos.prnewswire.com/prnh/20150729/248373 )  ...
Breaking Biology Technology:HealthSouth Reports Results for Second Quarter 2015 2HealthSouth Reports Results for Second Quarter 2015 3HealthSouth Reports Results for Second Quarter 2015 4HealthSouth Reports Results for Second Quarter 2015 5HealthSouth Reports Results for Second Quarter 2015 6HealthSouth Reports Results for Second Quarter 2015 7HealthSouth Reports Results for Second Quarter 2015 8HealthSouth Reports Results for Second Quarter 2015 9HealthSouth Reports Results for Second Quarter 2015 10HealthSouth Reports Results for Second Quarter 2015 11HealthSouth Reports Results for Second Quarter 2015 12HealthSouth Reports Results for Second Quarter 2015 13HealthSouth Reports Results for Second Quarter 2015 14HealthSouth Reports Results for Second Quarter 2015 15HealthSouth Reports Results for Second Quarter 2015 16HealthSouth Reports Results for Second Quarter 2015 17HealthSouth Reports Results for Second Quarter 2015 18HealthSouth Reports Results for Second Quarter 2015 19HealthSouth Reports Results for Second Quarter 2015 20HealthSouth Reports Results for Second Quarter 2015 21HealthSouth Reports Results for Second Quarter 2015 22HealthSouth Reports Results for Second Quarter 2015 23HealthSouth Reports Results for Second Quarter 2015 24HealthSouth Reports Results for Second Quarter 2015 25HealthSouth Reports Results for Second Quarter 2015 26HealthSouth Reports Results for Second Quarter 2015 27HealthSouth Reports Results for Second Quarter 2015 28HealthSouth Reports Results for Second Quarter 2015 29HealthSouth Reports Results for Second Quarter 2015 30HealthSouth Reports Results for Second Quarter 2015 31HealthSouth Reports Results for Second Quarter 2015 32HealthSouth Reports Results for Second Quarter 2015 33HealthSouth Reports Results for Second Quarter 2015 34HealthSouth Reports Results for Second Quarter 2015 35HealthSouth Reports Results for Second Quarter 2015 36
... 21, 2012 International scientific and government experts ... potential use of Oxitec,s genetically modified Aedes aegypti ... The independent forum was co-organised by the Smithsonian ... Studies and the University of Panama. This brought together national ...
... ROCKVILLE, Md., May 21, 2012  Neuralstem, Inc. (NYSE ... President, will present at the World Stem Cells ... ) on Tuesday, May 22nd at 12:30 PM. ... Disorders," will review Neuralstem,s cellular therapy trial in ...
... 18, 2012 Champions Oncology Inc. (OTC: CSBR) announced ... Amendment (CLIA) certification from the Maryland Department of Health ... for the company to conduct medical laboratory tests. ... "Obtaining CLIA approval is a significant milestone for our ...
Cached Biology Technology:Expert Meeting Discusses Testing of Oxitec Transgenic Mosquitoes in Panama 2Expert Meeting Discusses Testing of Oxitec Transgenic Mosquitoes in Panama 3Neuralstem CEO to Present at the World Stem Cells and Regenerative Medicine Congress in London 2Champions Oncology Inc. Receives Approval from U.S. Regulatory Authorities 2Champions Oncology Inc. Receives Approval from U.S. Regulatory Authorities 3
(Date:7/31/2015)... China , 31 de julio de 2015 ... www.icg-10.org ) se celebrará por medio de BGI del 22 al ... . Este año, la conferencia celebra ... ICG se ha convertido en una de las reuniones anuales ... ser una de las reuniones más dinámicas, entusiastas y mejores ...
(Date:7/31/2015)... 2015 The 10 th International Conference on ... October 22-25, 2015, in Shenzhen , ... celebrating its 10 th anniversary this year. Since its inauguration ... influential annual meetings in the ,omics, fields, and is one ... ICG-10 focuses on recent breakthroughs and advances in ...
(Date:7/27/2015)... July 27, 2015   Zynx Health ™, ... clinical improvement solutions, today announced that its ... available on Android smartphones and tablets. With this ... organizations can use ZynxCarebook to securely exchange messages ... streamline care transitions to other care settings, and ...
Breaking Biology News(10 mins):La 10th International Conference on Genomics (ICG-10) se llevará a cabo en octubre 2La 10th International Conference on Genomics (ICG-10) se llevará a cabo en octubre 3The 10th International Conference on Genomics (ICG-10) to Open in October 2Zynx Health Adds Android Device Support to ZynxCarebook Solution 2Zynx Health Adds Android Device Support to ZynxCarebook Solution 3
... and controversial technical barrier in stem cell biology, scientists ... Wisconsin-Madison have crafted a recipe that allows researchers to ... mouse-derived "feeder" cells, long thought to be a source ... The new findings, appear today (Feb. 17) in the ...
... other marine creatures, Aplysia, a common sea slug, enlists ... which such chemical attacks actually work against their intended ... has now shown that such chemical defenses can involve ... as components of chemical defense. , When attacked by ...
... by interfering with the biochemical signals one ovarian cell ... led by scientists at the USC/Norris Comprehensive Cancer Center ... of Southern California. , Their work is being published ... Biology. , "Before, we thought this gene was a ...
Cached Biology News:Scientists rid stem cell culture of key animal cells 2Scientists rid stem cell culture of key animal cells 3In the sea slug's defense against lobsters, confusion is key 2BRCA1 causes ovarian cancer through indirect, biochemical route 2BRCA1 causes ovarian cancer through indirect, biochemical route 3
Rat CXCL7/Thymus Chemokine-1 DuoSet Economy Pack, 45 Plate...
Recombinant Rat Fas Ligand/TNFSF6...
FGF Receptor 1 Antibody...
Rabbit polyclonal to Kallikrein 1 ( Abpromise for all tested applications). Antigen: Full length native kallikrein from tissue (Human) Entrez Gene ID: 3816 Swiss Protein ID: P06870...
Biology Products: