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Botanix Pharmaceuticals (ASX:BOT) gets U.S. FDA clearance for BTX 1801 development

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.

Australia’s first Antimicrobial Resistance Network forms to combat global health threat

Botanix welcomes, wholeheartedly, today’s news from MTPConnect announcing the formation of an Australian-first network to address the impact of antimicrobial resistance (AMR) on human health.

The Australian Antimicrobial Resistance network – AAMRNet – was launched in response to urgent recommendations in a new report by MTPConnect, ‘Fighting Superbugs: A Report on the Inaugural Meeting of Australia’s Antimicrobial Resistance Stakeholders’.

Professor Geoffrey Coombs, member of the AAMRNet Steering Committee and President of the Australian Society for Antimicrobials, is involved in our BTX 1801 clinical study in Perth. We are fortunate to be collaborating with leaders in this sector to examine the full potential of our platform AMR product.

Addressing the impact of AMR is a foremost priority for our business. We look forward to supporting this network and contributing valuable clinical data to our combined efforts to address what is one of the most significant, pressing threats to global health.

Read more from MTPConnect here.