News

For the latest media releases and news about Pharmaxis Ltd, please select from the following articles. Material news announcements made by Pharmaxis are first filed with the Australian Securities Exchange (ASX) and are also available on the ASX website.

29th Dec 09

Pharmaxis receives response letter from the FDA on Aridol application

Pharmaxis today announced it had received a Complete Response Letter from the U.S. Food and Drug Administration (FDA) in relation to its New Drug Application (NDA) for Aridol™ (mannitol inhalation powder).

 

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16th Dec 09

Pharmaxis lodges TGA application to market Bronchitol for CF in Australia

Pharmaxis today announced that it had submitted an application with the Therapeutic Goods Administration (TGA) to market Bronchitol in Australia for the treatment of cystic fibrosis.

 

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2nd Dec 09

Pharmaxis Announces Sustained Benefit with Bronchitol in Phase 3 Cystic Fibrosis Trial

Pharmaxis today announced significant headline results for the second six month dosing of its international Phase III trial of Bronchitol in people with cystic fibrosis.The lung function of patients treated with Bronchitol for a full twelve months improved from 6.5% at six months to 8.0% (p<0.001) at the end of twelve months treatment. In addition, the lung function of patients who were on placebo for the first six months of the study improved by 10.3% (p<0.001) when switched to Bronchitol.

 

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