Pharmaceutical research company Pharmaxis (ASX: PXS) has welcomed its inclusion in a new report which ranks the company among the top 100 most innovative pharma companies in the APAC region.
The report prepared by Cortellis and entitled “Pharmaceutical innovation in the APAC region”, studied a cohort of 929 companies (including multi-nationals) across 14 countries/regions that have or are developing innovative pharmaceutical products.
Pharmaxis was ranked 38 out of the 100 companies named as innovators in the small to medium- sized enterprises category. Amongst the 14 Australian companies included in the top 100, Pharmaxis was ranked second.
The Cortellis Report can be downloaded at: http://discover.clarivate.com/APAC_PharmaRankingRead full media release - pdf
Pharmaxis 2019 Directors' Report and Annual Financial StatementsRead report – pdf
Pathway to US Approval Clarified After FDA Issues Complete Response Letter on Use of Bronchitol for Adult CF Patients - NDA Expected to be Completed Q1 2020
Pharmaceutical company Pharmaxis (ASX: PXS) today announced its US licensee Chiesi Group (Chiesi) has received a complete response letter from the US Food and Drug Administration (FDA) detailing the remaining matters to be addressed before Bronchitol® can be approved for adult cystic fibrosis (CF) patients in the United States. Based upon the clear and achievable path to approval communicated in the FDA complete response letter, Pharmaxis believes that the FDA review of the Bronchitol NDA will be completed in Q1 2020.Read full media release - pdf