PERTH, Australia – Implicit Bioscience Ltd.’s lead candidate, IC-14, is the first anti-CD14 monoclonal antibody (MAb) to progress to the clinic as it enters a phase II trial in the U.S. in COVID-19 patients.
PERTH, Australia – The Australian government is recommending that Australians under 50 take the Pfizer Inc. COVID-19 vaccine due to the risk of rare blood clots associated with Astrazeneca plc’s COVID-19 vaccine (ChAdOx1-S). The move jeopardizes Australia’s vaccine rollout as it had planned for the majority of Australians to receive the Astrazeneca vaccine, which is being locally manufactured by CSL Ltd.
PERTH, Australia – Australia’s Therapeutic Goods Administration (TGA) has approved Australian manufacture of Astrazeneca plc’s COVID-19 vaccine (ChAdOx1-S), which is being manufactured by CSL Ltd.
PERTH, Australia – Sydney-based Azura Ophthalmics Ltd. has moved into a registration trial following positive phase II results for lead candidate AZR-MD-001 in Meibomian gland dysfunction, the leading cause of dry eye disease.
PERTH, Australia – Sydney-based Kazia Therapeutics Ltd. has out-licensed its ovarian cancer drug, Cantrixil (TRX-E-002-1), to Sweden’s Oasmia Pharmaceutical AB in a deal worth up to $46 million.
Oasmia will pay $4 million up front, and development milestones worth up to $42 million and double-digit sales royalties.
PERTH, Australia – With the first COVID-19 vaccine ready to be launched in Australia, the Therapeutic Goods Administration has released guidance on its pharmacovigilance plan to track real-world safety data and adverse events following immunization.
PERTH, Australia – The fight against diffuse intrinsic pontine glioma may finally see some progress, after experiments using 3D models of the tumor in animal studies showed that a combination therapy of the polyamine inhibitor AMXT-1501 (Aminex Therapeutics Inc.) and the ornithine decarboxylase 1 inhibitor difluoromethylornithine could eradicate cancer cells.
PERTH, Australia – Australia’s Therapeutic Goods Administration is proposing changes to its fees and charges and is asking stakeholders for feedback on three different proposed fee structures for the 2021-2022 financial year.
PERTH, Australia – Australia’s Therapeutic Goods Administration (TGA) has granted provisional approval to Astrazeneca Pty Ltd. for its COVID-19 vaccine, a recombinant adenovirus vaccine, making it the second COVID-19 vaccine to receive regulatory approval in Australia, following the Jan. 26 provisional approval for Pfizer Australia Pty Ltd.’s COVID-19 vaccine, branded Comirnaty.
PERTH, Australia – Synthetic cannabinoid company Botanix Pharmaceuticals Ltd. announced top-line data from a phase IIa study showing that two different formulations of BTX-1801, a synthetic cannabidiol (CBD), eradicated Staphylococcus aureus (staph) in the nose, meeting study endpoints for safety and efficacy.