Interview

The letter details the additional information the FDA requires to lift the clinical hold on Argenica’s investigational new drug application for ARG-007, a therapeutic aimed at reducing brain tissue death after stroke.

Regenerative medicine company Orthocell (ASX:OCC) says commercialisation of its flagship nerve repair product Remplir in the US is progressing on plan, with early clinical use and steps to secure broader hospital adoption underway.

Firebrick Pharma (ASX:FRE) has announced that it has received acceptance of its COVID-19 patent by the European Patent Office.

Australian preclinical biotechnology company Mirugen has secured investor backing to progress the development of its (re)programming cells to unlock innate cellular repair mechanisms.

AVITA Medical, a company in acute wound care, has successfully raised about US$15 million (~A$23 million) through a private placement of shares to investors in Australia.

In a move set to bolster investor engagement across Australia's life sciences sector, AusBiotech has announced the appointment of Kerri Lee Sinclair as its new Head of Investment.

PYC Therapeutics (ASX:PYC) has achieved notable progress in its Phase 1a Single Ascending Dose clinical trial for its RNA-based therapeutic candidate, PYC-003, targeting autosomal dominant polycystic kidney disease.

Neuren Pharmaceuticals (ASX:NEU) has announced the addition of SYNGAP1-related disorder to the development pipeline for its investigational therapy NNZ-2591, marking another step in the company’s strategy to target rare, genetically defined neurodevelopmental disorders.

Noxopharm (ASX:NOX) has announced significant progress in its HERACLES trial for SOF-SKN, a promising new drug candidate for autoimmune diseases.

Syntara CEO Gary Phillips said, "We will use the FDA guidance to refine our clinical development plan for amsulostat and continue discussions with partners based on the FDA recommended path forward."

Leading science and technology company Merck has welcomed new expert guidance that will harmonise the tests used in the diagnosis and treatment of endocrine disorders in children across Australia and New Zealand.

Cartherics, a company developing off-the-shelf immune stem cell therapies with lead programs in ovarian cancer and endometriosis, has unveiled its new, state-of-the-art cleanroom facility for clinical-scale manufacturing of cell therapy products.