South Korea’s Ministry of Food and Drug Safety (MFDS) will head an international team of regulatory experts from 19 drug agencies worldwide, including the U.S. FDA and China National Institute for Food and Drug Control (NIFDC), to draft an international standard for artificial intelligence (AI)-based software.
The U.S. and China biotech Apollomics Inc. on Nov. 16 gained the NMPA’s conditional approval for its cellular mesenchymal-epithelial transcription inhibitor for lung cancer called vebreltinib (APL-1010) through its Beijing-based partner, Avistone Biotechnology Co. Ltd.
The U.S. and China biotech Apollomics Inc. on Nov. 16 gained the NMPA’s conditional approval for its cellular mesenchymal-epithelial transcription inhibitor for lung cancer called vebreltinib (APL-1010) through its Beijing-based partner, Avistone Biotechnology Co. Ltd.
Siemens Healthineers AG appears to be committed to its Diagnostics business after Jochen Schmitz, CFO, pushed back at rumors speculating that the German company was looking at options for the underperforming segment, including a sale.
Immvira Group Co. plans to progress its intravenous oncolytic herpes simplex virus (oHSV) MVR-T3011-IV to phase II trials after completing a phase I study in the U.S. in patients with late-stage solid tumors. The Shenzhen, China-based company is the first to conduct clinical trials via intravenous administration of oHSVs.
In the following years, 2023 may come to be seen in medical device circles as the year of artificial intelligence (AI), but that doesn’t mean that 2023 will be seen as the year of regulatory clarity for AI.
Immvira Group Co. plans to progress its intravenous oncolytic herpes simplex virus (oHSV) MVR-T3011-IV to phase II trials after completing a phase I study in the U.S. in patients with late-stage solid tumors. The Shenzhen, China-based company is the first to conduct clinical trials via intravenous administration of oHSVs.
Astrazeneca plc will pay up to $2 billion for Eccogene Co. Ltd.’s oral weight loss candidate, ECC-5004, as big and small pharma players alike work to gain ground in the burgeoning obesity market where Eli Lilly and Co. scored the latest U.S. FDA approval of Zepbound (tirzepatide).
Another collaboration between two biopharmaceutical companies in the Asia-Pacific region is adding fuel to an already heated fire for antibody-drug conjugate (ADC) development worldwide. Suzhou, China-headquartered Genequantum Healthcare Co. Ltd. and South Korea’s Aimedbio Inc. recently announced extending an existing partnership to jointly develop five ADC investigative drugs.
Abbisko Therapeutics Co. Ltd. has received clearance from China's National Medical Products Administration (NMPA) to conduct clinical trials in China of ABSK-051, a novel small-molecule CD73 inhibitor, for advanced solid tumors.