PERTH, Australia – Although Australia’s deadly bushfires continue to burn, Australia’s Therapeutic Goods Administration (TGA) is not anticipating any effect on business operations.
Regulatory snapshots, including drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations in Asia-Pacific.
HONG KONG – Global pharmaceutical company Mundipharma Pte Ltd. is gaining exclusive commercialization rights in Taiwan and Hong Kong to four biosimilar candidates from South Korean biopharma Samsung Bioepis Co. Ltd. targeting immunology and oncology.
As we entered a new decade, BioWorld writers took the opportunity to review the highs and lows of the past 12 months and they concluded that 2019 was a great year for the sector – save for a few bumps in the road.
A mitochondrial glutamine transporter variant is a key regulator of glutamine metabolism and metabolic reprogramming in cancer cells, and targeting such transporters could be a new strategy for controlling tumor growth.
A reference genome from the Indian cobra compiled in an international collaborative study should lead to the development of new safer and more effective antivenoms, while the elucidated genome and predicted associated proteome may be a powerful platform for studies of venomous snakes.
San Diego-based Atyr Pharma Inc. CEO Sanjay Shukla told BioWorld that the company plans to move into a registrational trial with lead candidate ATYR-1923 in pulmonary sarcoidosis (PS) if data from the ongoing phase Ib/IIa trial, due later this year, turn out positive. Releasing patients from steroid burdens “would be a real game-changer,” he said, noting that people with PS take as much as 25 mg of prednisone per day to control their coughs and shortness of breath.