LONDON – More than six years after the technical specification was agreed, the EMA clinical trial information system (CTIS) has cleared the final hurdle and can go live in January 2022, after notice of approval was published in the EU Official Journal on Saturday July 31. The approval, following an independent audit of the system, was the spur for the EMA to intensify the training program it is putting in place for trial sponsors and national regulators, to ensure CTIS’ successful implementation.
LONDON – T-knife Therapeutics GmbH closed a $110 million series B, as it advances plans for the phase I/II trial of its first fully human T-cell receptor (TCR) in the treatment of solid tumors, which is due to start later this year.
LONDON – Relaxing of control measures such as mask wearing and social distancing at a time when most of a population has been vaccinated against COVID-19 greatly increases the probability of the emergence of a vaccine-resistant strain, according to a new modeling study.
PARIS – Peek Health SA raised $3.5 million in series A funding to ramp development of its 3D pre-op digital planning tools used in orthopedic surgery. This investment was led by two Portuguese venture capital firms: Grosvenor House of Investments SCR SA and Portugal Ventures SA.
PARIS – French sovereign bank Bpifrance SA, the Digital Health Agency (ANS) and Impact Healthcare SAS have just published results from the first survey on progress being made by digital health startups in France. The survey, with financial support from Astrazeneca plc from the U.K. and French law firm Delsol Avocats Selarl, was carried out among roughly 100 founders of digital health startups in France. It reveals a lot of information relating to the progress made by digital health projects 18 months following the outbreak of the COVID-19 pandemic. “It is a matter of recognizing there are barriers to the French market even though e-health products and services are booming following the COVID-19 crisis,” Jean-Yves Robin, managing director of Impact Healthcare and co-author of the study, told BioWorld.
LONDON – Memed Diagnostics Ltd. has adapted the point-of-care test it developed to distinguish bacterial from viral infections to enable rapid assessment of the severity of COVID-19 infections in patients being admitted to the hospital. The triaging tool, Memed COVID-19 Severity, has received a CE mark in Europe and is ready for commercial rollout. After securing the CE mark, Memed is now pursuing emergency use authorization for the test from FDA.
Researchers from Finland and Italy published a biomarker-based algorithm for the diagnosis of dementia in the journal Diagnostics. The algorithm enables clinicians to distinguish between various neurodegenerative diseases with shared clinical presentations and select appropriate treatment. The algorithm relies primarily on blood biomarker measurements to diagnose the type of dementia much earlier than is possible with the diagnostic tools in use today.
Medtronic plc launched the newest product in its coronary portfolio, the Prevail drug-coated balloon (DCB) catheter, in Europe following CE mark approval. The device is intended for use during minimally invasive procedures to open narrowed or clogged arteries in patients with coronary artery disease.
PARIS – The French government reported setting up the “Artificial Intelligence and Cancer” association, a public-private partnership that brings together the French National Cancer Institute (INCA), the Health Data Hub and the Health Industry Alliance for Research and Innovation (ARIIS), along with eight commercial firms. The eight commercial firms, whose identities have not yet been released, are drawn from a large consortium of pharmaceutical and information technology firms and health care insurers, that has been around since 2019.
PARIS – Royal Philips NV is working with the Spanish National Center for Cardiovascular Research (CNIC) on an ultrafast cardiac magnetic resonance imaging (MRI) protocol that could reduce scanning times to just a few minutes.
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