The biopharma industry lauded the first steps the Australian government has taken to widen access for drugs and devices via reforms to the current health technology assessment process that has remained unchanged for 30 years.
Ovarian cancer diagnostics company, Cleo Diagnostics Ltd. has developed a blood-based diagnostic test for ovarian cancer based on the CXCL10 biomarker, which is produced early and at high levels by ovarian cancers but is largely absent in nonmalignant disease.
Sciwind Biosciences Co. Ltd.’s oral ecnoglutide (XW-004) produced strong weight loss results after short-term treatments, up to a 6.8% body weight decrease in obese and overweight participants after once-daily dosing for six weeks, according to data from the first four cohorts of the phase I trial.
The U.S. FDA has granted Mesoblast Ltd.’s allogeneic cell therapy Revascor (rexlemestrocel-L) rare pediatric disease designation following submission of results from a clinical trial in children with hypoplastic left heart syndrome, a potentially life-threatening congenital heart condition.
The U.S. FDA has granted Mesoblast Ltd.’s allogeneic cell therapy Revascor (rexlemestrocel-L) rare pediatric disease designation following submission of results from a clinical trial in children with hypoplastic left heart syndrome, a potentially life-threatening congenital heart condition.
Axelia Oncology Pty Ltd. was spun out of Ena Respiratory Pty. Ltd., which developed a series of synthetic Toll-like receptor (TLR) 2/6 agonists for nasal delivery to treat respiratory infections, including influenza and SARS-CoV-2. Although the pegylated TLR 2/6 agonist, INNA-051, was initially focused on antiviral activity, the company discovered that it also worked in oncology models, and Axelia was spun out to focus on oncology, CEO Phil Kearney told BioWorld.
Researchers from the University of Auckland have developed a smartphone app called Mindear that reduced the impact of tinnitus in two-thirds of users over eight weeks.Tinnitus, often referred to as ringing in the ears, is the perception of sound without an external source and affects 10% to 15% of the global adult population. Previous studies to treat tinnitus have focused on neuromodulation devices, but a smartphone app could make treatment more accessible to a wider population.
Starpharma Holdings Ltd.’s DEP docetaxel phase II trial met its primary endpoints, demonstrating antitumor activity in multiple advanced, metastatic cancers, including pancreatic, gastro-esophageal, non-small-cell lung cancer and cholangiocarcinoma.
Olix Pharmaceuticals Inc. has received approval from the Alfred Human Research Ethics Committee (HREC) in Australia to conduct a phase I clinical trial of drug candidate OLX-75016 for the treatment of nonalcoholic steatohepatitis (NASH).
Asieris Pharmaceuticals Co. Ltd. announced that it has received approval to commence phase I clinical trials in Australia of its novel antibacterial drug, APL-2301 (ASN-1733, MET-102), under development for the treatment of Acinetobacter baumannii infections.
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