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.
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.
Metastatic colorectal cancer remains the second leading cause of cancer-related mortality globally, but treatment options are generally limited to RAS mutation status for anti-EGFR therapies. Researchers at the Walter and Eliza Hall Institute of Medical Research (WEHI) in Melbourne developed a method to grow organoids from patient-derived tumor samples that achieved 83% accuracy in predicting patient responses to different therapies.
In 2023, Japan has faced mounting criticism from the pharma industry for its annual price reductions. Ahead of the G7 summit hosted in Japan in May 2023, a delegation of 24 CEOs from the Biopharmaceutical CEO Roundtable met with Japanese Prime Minister Fumio Kishida to discuss global priorities and to flag concerns over drug pricing policies in Japan. Meanwhile, in 2023, China agreed to add 126 drugs to its National Reimbursement Drug List, in a negotiation process that has become more transparent and predictable than ever before. South Korea faces drug pricing reform, while Australia’s government has started an overhaul of its health technology assessment process.
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