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.
Chiesi Files Resubmission to Address FDA Bronchitol (Mannitol) Inhalation Powder Complete Response Letter
Pharmaceutical research company Pharmaxis Ltd (ASX: PXS) today announced its US licensee Chiesi Farmaceutici S.p.A., an international research-focused healthcare Group (Chiesi Group) has filed a resubmission that addresses the issues raised by the US Food and Drug Administration (FDA) in a complete response letter received in June 2019 to the Bronchitol® New Drug Application (NDA). This resubmission follows Chiesi Group’s successful completion of a supplemental human factor study in Q1 2020 which was the most significant body of additional data required by the FDA. The proposed indication for Bronchitol is management of cystic fibrosis to improve pulmonary function in patients 18 years of age and older in conjunction with standard therapies. The FDA review of the Bronchitol NDA is expected to be completed in mid-2020.Read full media release - pdf
Pharmaceutical research company Pharmaxis Ltd (ASX: PXS) is pleased to announce the appointment of experienced senior global pharma and biotech executive Dr Neil Graham to the Board as a non-executive director.
Dr Graham is a medicines development expert and infectious diseases epidemiologist who has had a distinguished academic and business career. He recently retired as Vice President of Strategic Program Direction at Regeneron (REGN:US) where he was responsible for the pipeline portfolio and successfully leading development of immunology and inflammation products from preclinical development to post-launch.Read full media release - pdf
Pharmaxis Ltd (ASX: PXS) chief executive officer Mr Gary Phillips will present at the NWR Virtual Health Conference to be held on Friday 1 May & Monday 4 May, 2020. Mr Phillips will provide details of recent progress in the Pharmaxis drug discovery pipeline and additional commentary on the information included in the latest Pharmaxis Quarterly Shareholder Update released earlier today, available of the company website.
Shareholders and investors are invited to participate in this free event.
Event: NWR Communications Virtual Health Conference
Presenting: Gary Phillips, CEO
Time/date: 1:40pm AEST, Friday 1 May
The event is free and investors should register in advance to view the presentation at: https://t.co/sY5jB3KKEi?amp=1Read full media release - pdf