When the data and safety monitoring board (DSMB) for Biocardia Inc.’s phase III pivotal trial of its Cardiamp cell therapy for heart failure advised pausing the study in July to analyze the interim results, the company expressed confusion as there were no reported treatment-emergent safety issues and aggregated blinded data showed better than expected outcomes. With the recommended external analysis now complete, the company confirmed the study is unlikely to achieve its primary endpoint at one year. The trial has now been unblinded.
Rapidly evolving artificial intelligence (AI) is effectively resetting all biopharmaceutical companies to the figurative starting line, and collaboration is a key strategy to winning the drug discovery race, an AI-based startup founder said at the Global Bio Conference (GBC) 2023.
Genexine Co. Ltd.’s recombinant human growth hormone eftansomatropin alfa (GX-H9/TJ-101) met the primary endpoint in a phase III pediatric study conducted in China in children with growth hormone deficiency, and the company plans to file a BLA in 2024 in China on the data.
Magassist Co. Ltd. has been granted a breakthrough device designation by the U.S. FDA for its interventional ventricular assist device (VAD), which is expected to accelerate the development and approval of the product.
Data-driven health care platform company Kakao Healthcare Corp. may be embarking on its most ambitious project yet: launching an effective “AI-platform bridge” over patient waters to connect medical institutions, government and the industry for novel drug discovery and research.
A woman in Nambour, Australia, is the first patient to receive a minimally invasive implantable neuromodulation device for severe migraine and cluster headache in a first-in-human study conducted by Salvia Bioelectronics BV.
Researchers at the National University of Singapore (NUS) developed an aero-elastic pressure sensor to be applied to minimally invasive surgeries, aiming to address issues caused by existing pressure sensors.
Verismo Therapeutics Inc., the U.S. subsidiary of South Korea’s HLB Co. Ltd., inked a license agreement with the University of Pennsylvania for two newly discovered CD19 binders – one of which will be used to develop Synkir-310, its investigative CAR T therapy for blood cancers.
SK Bioscience Co. Ltd. and Vaxxas Pty. Ltd. have entered into a joint development agreement that could revolutionize vaccines by developing a vaccine-delivery device combination product using Vaxxas’ high-density microarray patch (HD-MAP) coupled with SK Bioscience’s typhoid vaccine, Skytyphoid.
India is taking steps to separate how it regulates medical devices and pharmaceuticals, as it works to reduce its dependency on imports of devices and turn itself into a global hub for med-tech innovation and manufacturing.