PERTH, Australia – Sydney-based Kazia Therapeutics Ltd.’s shares soared nearly 82% this week on positive interim results for lead molecule GDC-0084 in a phase II glioblastoma trial. Data from the first nine patients in the study show that GDC-0084 treatment resulted in a median progression-free survival (PFS) rate of 8.4 months compared to the standard of care, temozolomide, which has a PFS of around 5.3 months. Read More
MELBOURNE, Australia – Researchers at the Murdoch Children’s Research Institute in Melbourne are pushing the boundaries on creating kidney tissue from stem cells. Read More
SINGAPORE – While a lot of focus is placed on phase III trials and the subsequent approvals, panelists during the ESMO Asia Congress pointed to the importance of designing the right kind of phase I trials, from reaching global populations to using appropriate endpoints. Read More
SINGAPORE – Takeda Pharmaceutical Co. Ltd. presented new findings from its phase III ALTA-1L trial evaluating its Alunbrig (brigatinib) vs. crizotinib in adults with advanced anaplastic lymphoma kinase-positive (ALK+) non-small-cell lung cancer (NSCLC) who had not received a prior ALK inhibitor, showing Alunbrig reduced the risk of disease progression or death by 76% after more than two years of follow-up. Read More
On its PDUFA date Thursday, the FDA cleared Xcopri (cenobamate) tablets from South Korea’s SK Biopharmaceuticals Co. Ltd. to treat partial-onset seizures in adults. The drug’s mechanism of action is not fully understood, but it's believed to work through two separate mechanisms: enhancing inhibitory currents through positive modulation of GABA-A receptors and decreasing excitatory currents by inhibiting the persistent sodium current. Read More
SINGAPORE – As the ESMO Asia Congress 2019 brought 3,679 participants from all over the Asia-Pacific region and beyond to Singapore’s Suntec Convention & Exhibition Centre, the focus, unsurprisingly, was on developments and challenges relevant to the oncology community. Read More
LONDON – It’s no secret that American citizens pay the most for drugs, but the extent of the disparity is laid bare in a new index of the prices of 13 medicines in 50 countries worldwide. Read More
HONG KONG – China-based Hua Medicine (Shanghai) Ltd.’s phase III trial of a potentially first-in-class dual-acting glucokinase activator, dorzagliatin, met its primary efficacy endpoint. Read More
BEIJING – Shenzhen-based Xbiome Co. Ltd., said to be China’s first AI-based microbiome drug development company, closed a series B financing round to pocket ¥100 million (US$14 million). Read More
HONG KONG – Lucence Diagnostics Pte Ltd., a genomic medicine company headquartered in Singapore, has secured $20 million in series A investment. Read More
Regulatory snapshots, including drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations in Asia-Pacific. Read More