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.
Pharmaceutical research company Pharmaxis Ltd (ASX: PXS) today announced its US licensee Chiesi Farmaceutici S.p.A. (Chiesi) has received acknowledgement of receipt of the Bronchitol NDA resubmission from the US Food and Drug Administration (FDA). The receipt of this communication from the FDA indicates that the submission responds to all issues raised in the complete response letter received in June 2019.
However, the FDA have classified the resubmission as Class 2 which changes the FDA review period from an expected two months to six months and sets a Goal Action Date of 1 November 2020.Read full media release - pdf
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