Navigation Links
Cystic Fibrosis - Orphan Drug Designation for Innovative Treatment Against Lung Infections by Axentis Pharma AG
Date:4/30/2009

ZURICH, Switzerland, April 30 /PRNewswire/ -- An innovative treatment for infections of the respiratory tract in cystic fibrosis patients has received orphan drug designation in the US. Axentis Pharma of Zurich, Switzerland announced today that this sought-after designation has been granted to its product candidate Fluidosomes-tobramycin, a therapeutic that will soon be tested in Phase II clinical trials. The company has now been granted orphan drug designation for this candidate in both Europe and the US.

Axentis Pharma (Switzerland) announced today that the Office of Orphan Products Development of the US Food and Drug Administration (FDA) has granted the orphan drug designation to its lead product candidate Fluidosomes-tobramycin. This drug is a liposomal formulation of tobramycin, an innovative treatment for infections of the respiratory tract in patients with cystic fibrosis that is delivered directly to the site of infection via standard nebulizers. Pre-clinical and Phase I clinical studies support improved safety and efficacy profiles for Fluidosomes-tobramycin as compared to currently marketed treatments for infections of the respiratory tract in patients with cystic fibrosis.

The orphan drug designation is granted with respect to treatment of pulmonary infections caused by Pseudomonas aeruginosa, a bacterium that is one of the most common causes of infections of the respiratory tract in patients with cystic fibrosis. Axentis Pharmas product candidate received the orphan drug designation for the US only two months after the application and less than one year after orphan designation in Europe was transferred to the company. Dr. Helmut Brunar, company CEO and President, comments: "The orphan drug designation for the US is very good news for affected patients as well as for Axentis Pharma's shareholders. Together with the Orphan Drug Designation that was already achieved last year in Europe, the US
'/>"/>

SOURCE Axentis Pharma AG
Copyright©2009 PR Newswire.
All rights reserved

Page: 1 2 3

Related medicine technology :

1. Promising Cystic Fibrosis Compound on Track for Development
2. Symbollon Pharmaceuticals, Inc. Evaluates the Clinical Effects of IoGen(TM) on Fibrocystic Breast Disease
3. Pediatric Pulmonary Expert Comments on Study of Lung Transplants for Cystic Fibrosis
4. Cystic Fibrosis Foundation Reports Upward Trend for Key Health Outcomes
5. Cystic Fibrosis Foundation Announces Positive Early Results for Phase 2 Clinical Trial of VX-770 - an Oral Compound to Treat CF
6. Lung Transplants in Cystic Fibrosis Patients With Life-Threatening Bacteria Sparks Debate at ISHLT Meeting
7. PTC Therapeutics Announces Data Supporting Cough Frequency as a New Outcome Measure in Evaluating Treatments for Cystic Fibrosis
8. PTC Therapeutics Announces Data from Additional Clinical Studies of PTC124 in Cystic Fibrosis Confirming Activity
9. Transave Announces Positive Phase II Results for Once-Daily Arikace(TM) in the Treatment of Cystic Fibrosis Patients Who Have Pseudomonas Lung Infections
10. Mpex Initiates a Phase 2 Clinical Trial of Aerosol MP-376 in the Treatment of Chronic Bacterial Infections in Cystic Fibrosis Patients
11. The Ocean Becomes a Pipeline To A Cure for Cystic Fibrosis
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:11/22/2014)... , Nov. 21, 2014  CytoSorbents Corporation ... its European Union approved CytoSorb® cytokine adsorber to ... awarded the Beacon of Light Award at last ... Dr. Phillip Chan , ... an honor to be recognized by the New ...
(Date:11/22/2014)... -- MEDITE Group acquired by CytoCore, Inc. (OTCBB: CYOE) on ... quarter sales ended September 30, 2014 of $8.7 million ... months ended September 2014 and a $38,000 loss for the ... quarter is usually a seasonable weak period due to the ... many countries worldwide, we are proud to announce record sales ...
(Date:11/21/2014)... Mass. , Nov. 21, 2014  Alere Inc. ... rapid diagnostic tests, has appointed Juliet Cunningham ... role, Cunningham will be responsible for driving communications with ... execute on a series of changes to increase shareholder ... progress to investors," said Namal Nawana, Chief Executive Officer. ...
Breaking Medicine Technology:CytoSorbents Wins Beacon of Light Award 2CytoSorbents Wins Beacon of Light Award 3CytoSorbents Wins Beacon of Light Award 4CytoCore Inc. / MEDITE Cancer Diagnostics, Inc. Reports Record YTD and 3rd Quarter Sales 2CytoCore Inc. / MEDITE Cancer Diagnostics, Inc. Reports Record YTD and 3rd Quarter Sales 3Alere Appoints Juliet Cunningham to Lead Investor Relations 2
... Pharmaceuticals, Inc. (Nasdaq: SVNT ) announced today ... will be released on Friday, February 25, 2011, at ... Johnson, Chief Executive Officer, and David Gionco, Group Vice ... community conference call and webcast at 9:00 a.m. Eastern ...
... SCOTTSDALE, Ariz., Feb. 17, 2011 ... interoperable workflow solutions, announced today that the University ... Physician Insight Plus™, one of many performance ... with Cleveland Clinic. The performance improvement dashboards are designed ...
Cached Medicine Technology:Savient Pharmaceuticals to Hold Fourth Quarter and Year-End 2010 Results Conference Call on Friday, February 25, 2011 2University of North Carolina Hospitals Selects Carefx Business Intelligence Dashboards To Drive Performance Improvement 2University of North Carolina Hospitals Selects Carefx Business Intelligence Dashboards To Drive Performance Improvement 3
(Date:11/24/2014)... The Holiday Inn Westbury - Long Island ... Association to donate various items consisting of practical, ... such items.The Association's program is aimed toward helping over ... nursing homes, assisted living facilities and nursing homes. The ... of seniors throughout the Long Island area. The Holiday ...
(Date:11/24/2014)... 2014 Mental health issues affect ... break up families, ruin careers, and generally destroy ... those that suffer,” says Hardy Nutritionals® ... that our specialized nutritional treatments can reverse these ... “Mind Over Matter”, the premiere episode of O2 ...
(Date:11/24/2014)... SafeHandles™ announced that they will be featured ... Jr, airing via Discovery Channel. Dates and show times ... non-invasive, replaceable, and affordable germ protective device. This segment ... and adhesives to promote hand hygiene in high traffic ... SafeHandles is the desire to make a positive impact ...
(Date:11/24/2014)... New York (PRWEB) November 24, 2014 Gersowitz ... today that it has received national Tier recognition in the ... Firms.” Achieving a tiered ranking signals a unique combination of ... are very proud to receive this honor and especially grateful ... made this important honor and ranking possible,” said Jeff S. ...
(Date:11/24/2014)... PA (PRWEB) November 24, 2014 "My ... he was trying to cross the street in his ... driver never saw him. I came up with this ... visible at night." , He developed the Safety Lites ... or in low-lighting conditions. The device ensures that motorists ...
Breaking Medicine News(10 mins):Health News:The Holiday Inn Westbury - Long Island gives back to the local Long Island community, and also goes beyond borders to assist those in need during the 2014 Holiday Season 2Health News:The Holiday Inn Westbury - Long Island gives back to the local Long Island community, and also goes beyond borders to assist those in need during the 2014 Holiday Season 3Health News:Nutritional Mental Health Treatment Featured on Access Health Airing on Lifetime Television® 2Health News:Nutritional Mental Health Treatment Featured on Access Health Airing on Lifetime Television® 3Health News:New Episode of Innovations TV Series to Feature SafeHandles™ 2Health News:U.S. News-Best Lawyers “Best Law Firms” Names Gersowitz Libo & Korek P.C. a 2015 Tier 1 Ranking Firm 2
... screened, treated more aggressively if deemed at risk, researchers ... have linked a genetic pattern to the likelihood that ... relapse. , The finding could lead doctors to screen ... more aggressively from the time of diagnosis, the researchers ...
... ... woman, and there is no way to prevent it. Although there is no definite way to ... natural remedies for menopause - believes that its symptoms can be cut short through the use ... Beverly ...
... ten patients who discontinued their overactive bladder (OAB) medication said ... couldn,t tolerate it, according to research in the May issue ... also discovered that smokers, men with enlarged prostates and people ... taking prescription drugs for bladder problems. The team surveyed ...
... the long-term economic consequences of childhood psychological disorders finds ... as adults, costing $2.1 trillion over the lifetimes of ... conditions such as depression and substance abuse are less ... their income reduced by about 20 percent over their ...
... ... document collaboration and video conferencing tool on the market, leveraging the secure NTT America ... ... VRMeetings, Inc. today announced the U.S. launch of MeetingPlaza, the world’s most advanced document ...
... ... pharmaceutical value-added programs and account managers among key managed care influencers. , ... Health Industries ... research project that provides strategic and tactical information to assist pharmaceutical manufacturers in ...
Cached Medicine News:Health News:Genetic Pattern May Predict Leukemia Relapse 2Health News:Can Menopause Be Shortened? Dr. Ershadi Discusses Possibility 2Health News:Can Menopause Be Shortened? Dr. Ershadi Discusses Possibility 3Health News:Unmet expectations and smoking prove key factors in quitting bladder medication 2Health News:Unmet expectations and smoking prove key factors in quitting bladder medication 3Health News:Childhood psychological problems create long-term economic losses, study finds 2Health News:Childhood psychological problems create long-term economic losses, study finds 3Health News:VRMeetings, Inc. Deploys the most Advanced Web-Based Video Conferencing and Document Collaboration Service over the Managed NTT America IT Infrastructure 2Health News:VRMeetings, Inc. Deploys the most Advanced Web-Based Video Conferencing and Document Collaboration Service over the Managed NTT America IT Infrastructure 3Health News:VRMeetings, Inc. Deploys the most Advanced Web-Based Video Conferencing and Document Collaboration Service over the Managed NTT America IT Infrastructure 4Health News:HIRC Research Alert: New Study Identifies Best Pharmaceutical Company Account Managers and Program Offerings 2Health News:HIRC Research Alert: New Study Identifies Best Pharmaceutical Company Account Managers and Program Offerings 3
... for the Quantitative Measurement ... S level based on ... Inhibition by STA© Analyzers. ... of Protein S; Human ...
Immuno-turbidimetric Assay for Antithrombin III Antigen. Suspension of microlatex particles coated with specific antibodies....
Enzyme Immunoassay of Protein C Antigenby ELISA Method, 96 tests...
Colorimetric Assay of Unfractionated and Low Molecular Weight Heparins by STA© Analyzers. Lyophilized, patent-pending chromogenic substate, CBS 52.44 of ~8.8 moles/vial and bovine factorXa ~2.2 ...
Medicine Products: