Navigation Links
Pharmaxis Announces Major Milestone: Positive Bronchitol Opinion for Europe
Date:10/24/2011

SYDNEY, Oct. 24, 2011 /PRNewswire/ -- Pharmaceutical company Pharmaxis (ASX: PXS) today announced the Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending the granting of a Marketing Authorisation for Bronchitol, clearing the way for the product to be used in Europe "for the treatment of cystic fibrosis in adults as an add-on therapy to best standard of care."

Pharmaxis expects the European Commission to confirm this opinion and grant the Marketing Authorisation for Bronchitol in January 2012.

Pharmaxis CEO Dr Alan Robertson welcomed the decision saying, "This outcome from the CHMP meeting is an important milestone for the company.  It is good news for the cystic fibrosis (CF) community which has supported us throughout the development of Bronchitol.  As the life expectancy of CF patients has lengthened, the size of the adult population in Europe has increased.  Bronchitol will be used for CF patients aged 18 and above, which represents about two thirds of all patients who could potentially benefit from the drug. Pharmaxis will undertake a short term clinical trial in children (age 6-17) with a view to extending the license to this age group.

"Bronchitol is a drug which was discovered and developed in Australia.  It is approved for marketing in Australia and is now set to become available throughout the 27 countries of the European Union.  This outcome represents the culmination of a great deal of work by many people.

"Pharmaxis will move quickly to commercialise Bronchitol in Europe.  We have established our supply and logistics arrangements and advanced launch preparations and pricing applications with our marketing partner, Quintiles.  The awareness of Bronchitol's clinical data amongst CF clinicians has increased through publications and presentations at scientific conferences.  European clinicians provided valuable support to the CHMP decision and
'/>"/>

SOURCE Pharmaxis
Copyright©2010 PR Newswire.
All rights reserved

Page: 1 2 3 4

Related medicine technology :

1. Pharmaxis Launches ARIDOL® (Mannitol Inhalation Powder) Bronchial Challenge Test Kit for the Assessment of Bronchial Hyperresponsiveness
2. Pharmaxis Previews New Bronchial Challenge Test at the Annual Meeting of the American College of Allergy, Asthma and Immunology
3. Pharmaxis Announces Positive Combined Phase 3 Cystic Fibrosis Trial Results
4. FDA Approves Pharmaxis ARIDOL™ (Mannitol Inhalation Powder) Bronchial Challenge Test Kit for the Assessment of Bronchial Hyperresponsiveness
5. Pharmaxis Announces Positive Results of Phase 3 Cystic Fibrosis Trial
6. Pharmaxis Announces Milestone in Phase III Trial for Cystic Fibrosis
7. Pharmaxis Announces New Drug Application Submission for Aridol(TM)
8. ASX/NASDAQ Media Release: Pharmaxis Files First Marketing Application for Bronchitol in Australia
9. Pharmaxis Concludes Special Protocol Assessment with FDA for Bronchitol Phase 3 Trial
10. Pharmaxis Establishes Named Patient Program for Bronchitol
11. Pharmaxis Long-Term Safety Study of Bronchitol Completes
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:9/22/2014)... 2014  Aethlon Medical, Inc. (OTCQB: AEMD), the ... infectious disease, cancer and other life-threatening conditions, disclosed ... (DARPA) has informed the Company that it plans ... four of a five-year $5.9 million contract that ... under DARPA,s Dialysis-Like Therapeutics (DLT) program. ...
(Date:9/22/2014)... Md. , Sept. 22, 2014  Neuralstem, Inc. (NYSE ... MD, site investigator at Emory University, presented long-term follow ... human neural stem cells in the treatment of amyotrophic ... The presentation, which occurred at the Annual Symposium on ... Canada , on Friday, and was not open ...
(Date:9/22/2014)... Pa. , Sept. 22, 2014  Olympus, ... innovative solutions for medical and surgical procedures, among ... a deal with Munich -based ... Kick ® Navigation. This agreement applies to ... for cross-disciplinary U.S. sales and all distribution outside ...
Breaking Medicine Technology:Aethlon Medical Receives Notice of DARPA Contract Renewal 2Aethlon Medical Receives Notice of DARPA Contract Renewal 3Aethlon Medical Receives Notice of DARPA Contract Renewal 4Neuralstem ALS Investigator Presents Long-Term Follow Up Phase I Data 2Neuralstem ALS Investigator Presents Long-Term Follow Up Phase I Data 3Neuralstem ALS Investigator Presents Long-Term Follow Up Phase I Data 4Olympus Partners with Brainlab as Exclusive Distributor for ENT Products in U.S. Market 2Olympus Partners with Brainlab as Exclusive Distributor for ENT Products in U.S. Market 3Olympus Partners with Brainlab as Exclusive Distributor for ENT Products in U.S. Market 4
... China, Dec. 27, 2011 /PRNewswire-Asia/ -- China Botanic ... ("China Botanic" or the "Company"), a developer, manufacturer ... Chinese Medicines ("TCM") in China, today announced that ... the 66th PHARMCHINA fair ("the Fair") recently held ...
... Reportlinker.com announces that a new ... its catalogue: Europe ... 2017- Glucose Monitoring and Insulin Delivery ... Europe Diabetes Care Devices ...
Cached Medicine Technology:China Botanic Exhibits All-Natural Anti-depressant Products at the 66th PHARMCHINA Fair 2China Botanic Exhibits All-Natural Anti-depressant Products at the 66th PHARMCHINA Fair 3Europe Diabetes Care Devices Market Outlook to 2017- Glucose Monitoring and Insulin Delivery 2Europe Diabetes Care Devices Market Outlook to 2017- Glucose Monitoring and Insulin Delivery 3Europe Diabetes Care Devices Market Outlook to 2017- Glucose Monitoring and Insulin Delivery 4Europe Diabetes Care Devices Market Outlook to 2017- Glucose Monitoring and Insulin Delivery 5Europe Diabetes Care Devices Market Outlook to 2017- Glucose Monitoring and Insulin Delivery 6Europe Diabetes Care Devices Market Outlook to 2017- Glucose Monitoring and Insulin Delivery 7Europe Diabetes Care Devices Market Outlook to 2017- Glucose Monitoring and Insulin Delivery 8Europe Diabetes Care Devices Market Outlook to 2017- Glucose Monitoring and Insulin Delivery 9Europe Diabetes Care Devices Market Outlook to 2017- Glucose Monitoring and Insulin Delivery 10Europe Diabetes Care Devices Market Outlook to 2017- Glucose Monitoring and Insulin Delivery 11Europe Diabetes Care Devices Market Outlook to 2017- Glucose Monitoring and Insulin Delivery 12
(Date:9/22/2014)... people both exercise more and drink more , Study ... activity , Findings differ from past research on physical ... Medicine study finds that on days when people exercise ... more alcohol, too. , This is the only study ... for self-reporting physical activity and alcohol use. , "Monday ...
(Date:9/22/2014)... (HealthDay News) -- Teens and young adults at risk ... to help prevent risky sexual behaviors, according to new ... Every year, about 20 million new sexually transmitted infections ... States. About half involve people between 15 and 24 ... Its new report, published Sept. 22 in Annals ...
(Date:9/22/2014)... ARBOR, Mich. A surprising new study pulls back ... in health care: differences in payment and income between ... who don,t. , Contrary to perception, the research ... to favor surgeons and other procedure-performing doctors. , The ... simple difference in pay per minute explains why doctors ...
(Date:9/22/2014)... New York, NY (PRWEB) September 22, 2014 ... pain on the side of the hip , ... for hip bursitis treatment in Manhattan. This treatment is now offered ... bursitis, which is also called trochanteric bursitis, occurs when ... is a fluid-filled sac in the hip, between the ...
(Date:9/22/2014)... Reinberg HealthDay Reporter MONDAY, ... all children aged 6 months and older be vaccinated for ... updated their influenza vaccine recommendations to advise that the youngest ... immunity. The AAP also wants parents of children aged 2 ... vaccine instead of the flu shot if it,s readily available. ...
Breaking Medicine News(10 mins):Health News:We drink more alcohol on gym days 2Health News:Behavioral Counseling Urged for Teens, Young Adults at Risk for STDs 2Health News:Behavioral Counseling Urged for Teens, Young Adults at Risk for STDs 3Health News:Think the system for paying US doctors is rigged to favor surgeons? Study may surprise you 2Health News:Think the system for paying US doctors is rigged to favor surgeons? Study may surprise you 3Health News:Think the system for paying US doctors is rigged to favor surgeons? Study may surprise you 4Health News:DNR Clinic Offers Hip Bursitis Treatment in Manhattan 2Health News:DNR Clinic Offers Hip Bursitis Treatment in Manhattan 3Health News:Pediatricians Urge Flu Vaccine for All Kids 6 Months and Older 2Health News:Pediatricians Urge Flu Vaccine for All Kids 6 Months and Older 3
... cancer is the most common cancer diagnosed among men in ... There are several // treatment options, but new research shows ... , Doctors hope that the drug -- finasteride ... smaller doses, it’s commonly known as Propecia for baldness. It ...
... A new study finds angioplasty should be the treatment ... hospital they initially go to doesn’t offer angioplasty// services ... for treatment. ,Research has shown heart attack patients ... open up the clogged blood vessel that caused the ...
... New research reports, patients who were treated for depression ... vitamin B12 in their blood.// ,An increasing amount ... B and depression, but the specifics have not been ... relationship of vitamin B12 and the treatment of depression. ...
... A new study shows people who suffer from migraine headaches ... which are areas of the brain where the tissue has ... ages 30 to 60. They grouped the patients into categories ... no visual difficulties. A control group was also included in ...
... new study finds people who participated in a cardiac-rehab program ... rate // as those of the same age and sex ... about half of the deaths that occurred among patients in ... cardiac-rehab program. ,The investigation involved about 1,800 patients. Nearly ...
... from extremely low body fat whether due to strenuous ... from treatment with the appetite-and-weight-regulation hormone leptin.// The study ... instances of infertility. ,Leptin is produced in fat ... then travels to the brain and plays a role ...
Cached Medicine News:
Bechert-McPherson tying forceps, angled, 10 mm tying platforms....
Girard curved tying forceps made of titanium has curved shafts with 8 mm tying platforms, width of shafts 0,25 mm, TCI platforms, round handle, diam. 6 mm, overall length 99 mm....
Curved tying forceps made of titanium has curved shafts with 6 mm V-grove tying platforms, width of shafts 0,5 mm, TCI platforms, flat handle, width 10 mm, overall length 103 mm....
Straight tying spring forceps made of titanium, delicate smooth jaws, length 10 mm, TCI jaws with round handle, diam. 8 mm and overall length 115 mm....
Medicine Products: