Otsuka Pharmaceutical Co. Ltd. has gone back on efforts to get its medicine, Asimtufii (aripiprazole), a long-acting maintenance treatment for schizophrenia, approved in Europe, after the EMA gave a provisional negative opinion.

Tissium SA reported the close of a series D funding round, raising $54 million from investors both new – such as Mérieux Développement SAS – and long-term, including Cathay Capital Co. Ltd., Crédit Mutuel Innovation SAS and original investors, Sofinnova Partners SAS.

The U.K. government has announced £121 million (US$148 million) in funding to reboot the commercial clinical trials system after a sharp decline saw the number of industry-sponsored studies falling by 44% from 2017 to 2021.

Otsuka Pharmaceutical Co. Ltd. has gone back on efforts to get its medicine, Asimtufii (aripiprazole), a long-acting maintenance treatment for schizophrenia, approved in Europe, after the EMA gave a provisional negative opinion.

Researchers from the French institute of health and medical research (INSERM) and the University of Bordeaux, France, have developed an artificial intelligence (AI) tool to leverage hospital data for trauma patients. They have published results for a new algorithm capable of classifying trauma-related emergency room visits in the Journal of Medical Internet Research – Artificial Intelligence. “Thanks to this new AI tool, we have generated highly accurate data that allows us to accurately classify the mechanisms of trauma, which represent one third of emergency room visits in France,” said Gabrielle Chenais, research specialist and data scientist at the Bordeaux Population Health (BPH) Research Centre. BPH is a research body run by INSERM and the University of Bordeaux.

The French National Authority for Health, known in France as the Haute Autorité de la Santé (HAS), recently published a favorable opinion regarding reimbursement for the first diagnostic test to benefit under an innovation initiative. The test is the Metaglut1 test from Metafora Biosystems SAS, a non-invasive diagnostic test that identifies glucose transporter type 1 deficiency syndrome (Glut1DS).

Elixir Medical Corp. reported that the Bioadaptor randomized controlled trial which compared its Dynamx coronary drug-eluting bioadaptor system to Dublin-based Medtronic plc’s Resolute Onyx drug-eluting stent (DES) in de novo native coronary arteries, met its primary endpoint of target lesion failure (TLF) non-inferiority at 12 months. The results were presented at a late-breaking clinical session during the EuroPCR 2023 conference in Paris.

Abbott Laboratories Inc. reported late-breaking data from the Bright study which showed that its Triclip transcatheter edge-to-edge repair (TEER) system reduced tricuspid regurgitation and improved the quality of life of patients with leaky tricuspid valves. The results from the largest real-world dataset were presented, for the first time, at the EuroPCR 2023 conference in Paris.

Olympus Europa SE & Co. KG is launching three Endoclot products, two hemostatic agents and a submucosal injection agent, in the Europe, Middle East and Africa (EMEA) region. This new portfolio was developed by Santa Clara, Calif.-based Endoclot Plus Inc., which expanded its distribution with Olympus from the U.S. to EMEA in December 2022. “The addition of their solutions to our portfolio allows Olympus to contribute to safe treatment in gastrointestinal procedures. We aim to improve patient outcomes and hereby elevate the standard of care,” said Stefanie Kaufung, EMEA business unit manager gastrointestinal endotherapy at Olympus.