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The Australian Government Department of Health has this week published a summary of funding and strategy measures announced to address antimicrobial resistance (AMR) in the recent 2020-21 Federal Budget. This includes $22.5m to address the priorities identified in Australia’s National Antimicrobial Resistance Strategy – 2020 & Beyond.
Key areas, as quoted in this excerpt, include:
Surveillance ofAntimicrobial Use and Resistance
Continuation and enhancement of the Antimicrobial Use and Resistance (AURA) Surveillance System that provides a comprehensive and integrated picture of trends of antimicrobial use and resistance in human health.
Assessment of Australia’s current capabilities and resource needs to develop a One Health Surveillance System. This scoping and planning phase will entail consultation with stakeholders on how to achieve the implementation of a One Health Surveillance System that integrates resistance and usage data from human health, animal health, agriculture, food and environment sectors in Australia.
The Department of Agriculture, Water and the Environment will conduct scoping studies to collect baseline data on antimicrobial resistance and usage in the animal health sector.
A pilot study will be conducted to collect baseline data on the presence of antimicrobials and resistant organisms in food. FSANZ will be responsible for this project which will commence in mid-2021.
Support for the development of a Multi-Drug Resistant Organism (MRO) outbreak response capability with state and territory health authorities. This will enable a timely response to outbreaks of priority MROs detected by surveillance; building on existing capacity.
Develop a National AMR One Health Research and Development Agenda (AMR R&D Agenda). The intention is to work with stakeholders to identify gaps and priority areas for research on the prevention, detection and containment of AMR across the differing areas of research; i.e. operational and implementation, therapeutics, preventives and diagnostics. The agenda will also consider opportunities for collaboration, both nationally and internationally, and to reduce potential duplication of effort.
Undertake a scoping study on pricing and reimbursement to identify new and innovative funding models to support incentivising new products that prevent, detect and contain drug-resistant infections in Australia. The study will be informed by the outcomes and lessons learned of similar studies conducted internationally.
Develop a national monitoring and evaluation framework to measure Australia’s progress towards achieving the objectives of the 2020 AMR Strategy. This work is planned to commence in mid-2021.
Maintain Australia’s AMR governance arrangements such as the Australian Government’s AMR advisory group; the Australian Government One Health AMR website (amr.gov.au), and meeting national and international reporting obligations.
Botanix Pharmaceuticals’ President and Executive Chairman, Vince Ippolito, commented: “Botanix Pharmaceuticals has this week announced that we have secured a clear development path from the FDA for our BTX 1801 synthetic cannabidiol antimicrobial product, following the successful completion of a Pre-Investigational New Drug (Pre-IND) meeting. Our BTX 1801 Phase 2a study in Perth is fully enrolled and remains on track for completion before the end of this calendar year.
“We welcome support from the Australian Federal Government as we develop our BTX 1801 antimicrobial pipeline and are committed to active and collaborative participation in the whole-of-industry response needed to address this pressing global health emergency.”
– ENDS –
https://botanixpharma.com/wp-content/uploads/AdobeStock_126570978-scaled.jpeg17072560Haley Chartres/wp-content/uploads/botanix-logo.pngHaley Chartres2020-11-13 04:50:332023-03-13 21:16:45Australian Government makes strong commitment to fund the fight against AMR
Botanix Pharmaceuticals (BOT) has completed a pre-investigational new drug meeting with the U.S. Food and Drug Administration’s (FDA) Office of Infectious Diseases.
The meeting assessed the potential of initiating clinical development of the company’s BTX 1801 antimicrobial drug for preventing surgical site infections (SSIs) in the U.S.
It also enabled the company to receive feedback from the FDA on the drug development plan needed for BTX 1801 to support a Fast Track designation and New Drug Application (NDA).
Click through to read the full article on The Market Herald here.
https://botanixpharma.com/wp-content/uploads/AdobeStock_242863559-scaled.jpeg17072560Haley Chartres/wp-content/uploads/botanix-logo.pngHaley Chartres2020-11-12 01:58:132023-03-13 21:16:45Botanix Pharmaceuticals (ASX:BOT) gets U.S. FDA clearance for BTX 1801 development
The Green Fund has published a summary of Botanix Pharmaceutical’s BTX 1801 announcement today, an update on the development pathway for our BTX 1801 antimicrobial product.
https://botanixpharma.com/wp-content/uploads/Screen-Shot-2020-11-12-at-12.40.46-pm.png9701462Haley Chartres/wp-content/uploads/botanix-logo.pngHaley Chartres2020-11-12 01:42:262023-03-13 21:16:45Botanix Pharma Talks With FDA on Antibacterial Drug
Botanix (ASX:BOT) has today announced it has secured a clear development path from the FDA for its BTX 1801 synthetic cannabidiol antimicrobial product, following the successful completion of a Pre-Investigational New Drug (Pre-IND) meeting.
Our team will have more clinical data to share soon too – our BTX 1801 Phase 2a study in Perth is fully enrolled and remains on track for completion before the end of this calendar year.
Botanix Pharmaceuticals has released its latest Quarterly Report – a period which has delivered a series of progress milestones.
In our antimicrobial program, we commenced a Phase 2a clinical trial for BTX 1801 to study the use of synthetic cannabidiol in the prevention of surgical site infections. We also shared new data from an ex vivo efficacy study, which further validates the mechanism of action of our antimicrobial platform.
In our dermatology program, we successfully completed an End of phase 2 meeting with the FDA for our BTX 1503 acne product. We’re also looking forward to commencing recruitment for our BTX 1702 program for the treatment of Rosacea, when COVID-19 travel restrictions ease.
Botanix has appeared in a must-read feature about antimicrobial resistance (AMR) in the latest edition of AusBiotech’s Australasian Biotechnology Journal.
It is titled, “Antimicrobial resistance: a global health emergency”.
A quote from WHO Director-General Dr Tedros Adhanom Ghebreyesus, featured in the story, points to the importance of the work we are doing in this space:
“AMR is a slow tsunami that threatens to undo a century of medical progress. A record number of countries are now monitoring and reporting on antibiotic resistance to WHO”.
https://botanixpharma.com/wp-content/uploads/WEBSITE.png9001600administrator/wp-content/uploads/botanix-logo.pngadministrator2020-10-12 21:28:002023-03-13 21:17:07Antimicrobial resistance: a global health emergency
Australian Government makes strong commitment to fund the fight against AMR
/in Featured, Latest News, News /by Haley ChartresThe Australian Government Department of Health has this week published a summary of funding and strategy measures announced to address antimicrobial resistance (AMR) in the recent 2020-21 Federal Budget. This includes $22.5m to address the priorities identified in Australia’s National Antimicrobial Resistance Strategy – 2020 & Beyond.
Key areas, as quoted in this excerpt, include:
Botanix Pharmaceuticals’ President and Executive Chairman, Vince Ippolito, commented: “Botanix Pharmaceuticals has this week announced that we have secured a clear development path from the FDA for our BTX 1801 synthetic cannabidiol antimicrobial product, following the successful completion of a Pre-Investigational New Drug (Pre-IND) meeting. Our BTX 1801 Phase 2a study in Perth is fully enrolled and remains on track for completion before the end of this calendar year.
“We welcome support from the Australian Federal Government as we develop our BTX 1801 antimicrobial pipeline and are committed to active and collaborative participation in the whole-of-industry response needed to address this pressing global health emergency.”
– ENDS –
Botanix Pharmaceuticals (ASX:BOT) gets U.S. FDA clearance for BTX 1801 development
/in Featured, Latest News, News /by Haley ChartresBotanix Pharmaceuticals (BOT) has completed a pre-investigational new drug meeting with the U.S. Food and Drug Administration’s (FDA) Office of Infectious Diseases.
The meeting assessed the potential of initiating clinical development of the company’s BTX 1801 antimicrobial drug for preventing surgical site infections (SSIs) in the U.S.
It also enabled the company to receive feedback from the FDA on the drug development plan needed for BTX 1801 to support a Fast Track designation and New Drug Application (NDA).
Click through to read the full article on The Market Herald here.
Botanix Pharma Talks With FDA on Antibacterial Drug
/in Featured, Latest News, News /by Haley ChartresThe Green Fund has published a summary of Botanix Pharmaceutical’s BTX 1801 announcement today, an update on the development pathway for our BTX 1801 antimicrobial product.
Take a look at the article here.
BTX 1801 Update
/in ASX Releases, Featured, Latest News, News /by Haley ChartresBotanix (ASX:BOT) has today announced it has secured a clear development path from the FDA for its BTX 1801 synthetic cannabidiol antimicrobial product, following the successful completion of a Pre-Investigational New Drug (Pre-IND) meeting.
Our team will have more clinical data to share soon too – our BTX 1801 Phase 2a study in Perth is fully enrolled and remains on track for completion before the end of this calendar year.
Read today’s ASX release here.
Quarterly Report
/in Featured, Latest News, News /by administratorBotanix Pharmaceuticals has released its latest Quarterly Report – a period which has delivered a series of progress milestones.
In our antimicrobial program, we commenced a Phase 2a clinical trial for BTX 1801 to study the use of synthetic cannabidiol in the prevention of surgical site infections. We also shared new data from an ex vivo efficacy study, which further validates the mechanism of action of our antimicrobial platform.
In our dermatology program, we successfully completed an End of phase 2 meeting with the FDA for our BTX 1503 acne product. We’re also looking forward to commencing recruitment for our BTX 1702 program for the treatment of Rosacea, when COVID-19 travel restrictions ease.
Read the full report here.
Antimicrobial resistance: a global health emergency
/in Featured, Journal Articles, Latest News, News /by administratorBotanix has appeared in a must-read feature about antimicrobial resistance (AMR) in the latest edition of AusBiotech’s Australasian Biotechnology Journal.
It is titled, “Antimicrobial resistance: a global health emergency”.
A quote from WHO Director-General Dr Tedros Adhanom Ghebreyesus, featured in the story, points to the importance of the work we are doing in this space:
“AMR is a slow tsunami that threatens to undo a century of medical progress. A record number of countries are now monitoring and reporting on antibiotic resistance to WHO”.
Read the full story on pages 52-54 here.