Shanghai’s State Medical Products Administration announced that GSK plc has been banned from participating in volume-based procurement tenders until April 29, 2024, after failing a good manufacturing practices (GMP) inspection at a contract manufacturing plant in Poland that makes products for China.
The potential for psychedelics to deliver long-lasting benefits for people with anxiety, depression, post-traumatic stress disorder and addiction is being put to the test in Australia, where new research and discovery centers are adding to a global enterprise of nearly 100 clinical trials underway in the space.
South Korea’s regenerative medicine market is expected to grow from $51 million in 2016 to $320 million by 2026, growing at a compound annual growth rate of 20%, So Ra Park, chair and founder of Korea’s Regenerative Medicine Acceleration Foundation said.
China’s National Medical Products Administration (NMPA) established new medical device regulations earlier in the year aimed at spurring innovation and creating regulatory incentives, and although the regulation has shortened review and approval timelines, other benefits are less clear, experts said.
The potential for psychedelics to deliver long-lasting benefits for people with anxiety, depression, post-traumatic stress disorder and addiction is being put to the test in Australia, where new research and discovery centers are adding to a global enterprise of nearly 100 clinical trials underway in the space.
South Korea’s regenerative medicine market is expected to grow from $51 million in 2016 to $320 million by 2026, growing at a compound annual growth rate of 20%, So Ra Park, chair and founder of Korea’s Regenerative Medicine Acceleration Foundation said during the Ausbiotech 2022 conference in Perth, Australia, running Oct. 26 to 28.
Sumitovant Biopharma Ltd., a subsidiary of Sumitomo Pharma Co. Ltd., agreed to acquire Myovant Sciences Ltd. for $27 per share, up from its earlier offer of $22.75 per share. The deal is worth $1.7 billion on a fully diluted basis, with an equity value of about $2.59 billion.
Astellas Pharma Inc. has invested $50 million in Taysha Gene Therapies Inc. in exchange for 15% of the company and exclusive options to in-license Taysha’s lead gene therapy candidates, TSHA-102 for Rett syndrome and TSHA-120 for giant axonal neuropathy.
Celltrion Healthcare Inc. has signed a deal with Pinotbio Inc. to develop antibody-drug conjugates (ADCs) for up to 15 separate cancer targets incorporating the linker-payload platform technology Pinot-ADC. Celltrion could pay Pinotbio as much as ₩1.77 trillion (US$1.24 billion) to exercise options for all 15 targets in the collaboration. But, for starters, it will pay Pinotbio ₩1 billion up front.
Radiopharm Theranostics Ltd.’s phase II F-18 Pivalate positron emission tomography trial in brain metastases saw positive results with high uptake regardless of the origin of primary tumors, showing that Pivalate could be used to monitor brain metastases.
