Kazia Therapeutics Ltd. stopped its two-part paxalisib plus radiotherapy phase I trial early based on positive safety and promising clinical responses in patients with phosphoinositide 3-kinase pathway mutation brain metastases from solid tumors. The company plans to meet with the U.S. FDA to discuss a pivotal registrational trial.
In a surprise reveal that propelled stocks by 25%, Alteogen Inc., of Daejeon, South Korea, named MSD International Business GmbH as its counterpart in a near-$4 billion technology transfer agreement inked in 2020, while upping terms of the deal.
Global interest in radiopharmaceuticals is soaring, and the global radiopharma market is expected to grow 10% over the next decade to $13.67 billion by 2032, according to a new report by Precedence Research.
SK Bioscience Co. Ltd. of Seongnam-si, South Korea, gained the World Health Organization’s (WHO) prequalification certification for typhoid conjugate vaccine, Skytyphoid (NBP-618), on Feb. 23. Skytyphoid conjugates a polysaccharide of typhoid bacteria, which serves as an antigen, to a diphtheria toxin protein called diphtheria toxoid that acts as a carrier.
Korean neurodegenerative disease-focused Aribio Co. Ltd. gained the U.K.’s regulatory clearance to start the phase III Polaris-AD trial on AR-1001 (mirodenafil), an investigative therapy for early Alzheimer’s disease (AD). The U.K.’s Medicines and Healthcare products Regulatory Agency gave notice of acceptance to Seoul, South Korea- and San Diego-based Aribio for the clinical study on Feb. 21 after “confirming a favorable ethical opinion,” Aribio said. AR-1001 is an oral phosphodiesterase-5 inhibitor under development to treat early AD.
With the number of people with dementia in Australia expected to nearly double by 2054, the federal government is funding a new AU$50 million (US$32.76 million) biomedical and med-tech incubator program to develop new therapies, medical devices and digital health technologies to address dementia and cognitive decline.
Australia’s Therapeutic Goods Administration (TGA) proposed in July 2023 to develop a framework for audits for premarket device applications, but the Medical Technology Association of Australia (MTAA) registered several concerns about the proposal.
In a surprise reveal that propelled stocks by 25%, Alteogen Inc., of Daejeon, South Korea, named MSD International Business GmbH as its counterpart in a near-$4 billion technology transfer agreement inked in 2020, while upping terms of the deal.
A new cutting-edge blood-based biomarker test developed by researchers at Hong Kong University of Science and Technology can detect early Alzheimer’s disease (AD) and mild cognitive impairment (MCI), with accuracy rates surpassing 96% and 87% respectively, and could be a game changer in detecting and treading early AD.
Kazia Therapeutics Ltd. stopped its two-part paxalisib plus radiotherapy phase I trial early based on positive safety and promising clinical responses in patients with phosphoinositide 3-kinase pathway mutation brain metastases from solid tumors. The company plans to meet with the U.S. FDA to discuss a pivotal registrational trial.