Pharmaxis Ltd Company Profile
Pharmaxis (ACN 082 811 630) is a specialist pharmaceutical company involved in the research, development and commercialization of therapeutic products for chronic respiratory disorders. Its product Aridol® for the assessment of asthma is launched in a number of key markets. Its development pipeline of products includes: Bronchitol for cystic fibrosis, bronchiectasis and chronic obstructive pulmonary disease (COPD), ASM8 for asthma, PXS25 for idiopathic pulmonary fibrosis and a new oxidase inhibitor for lung disease. Pharmaxis is listed on the Australian Securities Exchange (symbol PXS). The company is headquartered in Sydney at its TGA-approved manufacturing facilities. For more information about Pharmaxis, go to www.pharmaxis.com.au or contact Investor Relations on phone +61 2 9454 7200.
News Articles
Pharmaxis Gets Negative Recommendation From U.S. FDA Advisory Panel
Australia's Pharmaxis had a setback when U.S. FDA advisors recommended rejection of its Bronchitol (manitol) for treating cystic fibrosis in persons over six years of age.
US FDA calls for new trial with Pharmaxis' CF drug Bronchitol
Australian pharma company Pharmaxis (ASX: PXS) says it has received a complete response letter from the Food and Drug Administration confirming Bronchitol (mannitol dry powder for inhalation) cannot y...
Panel rebuffs Pharmaxis' Bronchitol for CF
FDA's Pulmonary-Allergy Drugs Advisory Committee voted 14-0 against approval of an NDA for Bronchitol mannitol from Pharmaxis Ltd. (ASX:PXS; Pink:PXSLY) to improve pulmonary function in cystic fibrosi...
Pharmaxis receives Bronchitol complete response
Pharmaxis Ltd. (ASX:PXS; Pink:PXSLY) received a complete response letter from FDA for an NDA for Bronchitol mannitol to improve pulmonary function in cystic fibrosis (CF) patients six years of age and...
Pharmaxis tumbles on FDA rejection of Bronchitol in CF
Given the unanimous snub it got in January from a US FDA panel of advisers, it came as little surprise regulators rejected Pharmaxis' new drug application for Bronchitol, an experimental dry-powder...
Pharmaxis' Bronchitol gets NICE thumbs down for cystic fibrosis
NICE, the health technology appraisal institute for England and Wales, says it is unable to recommend Pharmaxis' Bronchitol (mannitol dry powder) for treating cystic fibrosis on the NHS. There were to...
Pharmaxis seeks US FDA OK for inhaled mannitol in CF
Australian specialty drug maker Pharmaxis submitted a new drug application (NDA) to the US FDA for Bronchitol, a formulation of mannitol administered as a dry powder in a hand‐held inhaler, as...
NICE OKs Pharmaxis and Novartis drugs but not Forest's colistimethate in CF patients
In a wave of developments for cystic fibrosis (CF), NICE, the health technology appraisal institute for England and Wales, has recommended Pharmaxis's Bronchitol (mannitol dry powder) as a treatment o...
Drugs and Medications
Aridol bronchial challenge test kit [Pharmaxis Ltd]
These highlights do not include all the information needed to use ARIDOL safely and effectively. See full prescribing information for ARIDOL. ARIDOL™ (mannitol inhalation powder) Bronchial Challenge...
PubMed Articles
Asthma & COPD - IQPC's Second Conference.
The International Quality & Productivity Center's (IQPC) Second Asthma & COPD conference, held in Philadelphia, included topics covering new therapeutic developments in the field of asthma and COPD. T...
BACKGROUND: Allergic rhinitis (AR) and asthma are closely related conditions that often co-exist, and are characterized by a Th2 inflammatory response where eosinophils occupy a predominant role. Stra...
Dose-response effects of TPI ASM8 in asthmatics after allergen.
To cite this article: Gauvreau GM, Pageau R, Séguin R, Carballo D, Gauthier J, D'Anjou H, Campbell H, Watson R, Mistry M, Parry-Billings M, Killian K, Renzi PM. Dose-response effects of TPI ASM8 in a...
Clinical Trials
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Companies
Pharmaxis (ACN 082 811 630) is a specialist pharmaceutical company involved in the research, development and commercialization of therapeutic products for chronic respiratory diso...
Pharmaxis Ltd is a specialist pharmaceutical company established to research, development and bring to market human therapeutic products to treat chronic respiratory and autoimmune diseases. Founded...
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