PARIS – In France, the Haute Autorité de Santé, or National Health Authority (HAS), recently reported the entry into force of a new plan for "temporary" adoption under social security for innovative medical devices. The aim is to speed up access to the French insurance reimbursement market for medical technology addressing unmet or poorly met clinical needs in the context of serious or rare conditions, or which help disability in France.
PARIS – Aptargroup Inc. is negotiating to buy Voluntis SA in a move that would complement its existing digital solutions portfolio and expand services to address multiple conditions and chronic diseases. "By being part of Aptar, we will be able to pursue a common ambition aimed at providing a complete digital health platform combining connected devices and digital therapeutics," Pierre Leurent, CEO and co-founder of Voluntis, told BioWorld.
DUBLIN – In a busy week at the EMA, its Committee on Human Medicinal Products (CHMP) nodded through eight marketing applications at its June meeting. The haul included a chimeric antigen receptor T-cell (CAR T) therapy, three antibodies, including a biosimilar, and two new small-molecule drugs, as well as two generics.
Boehringer Ingelheim GmbH has begun a three-year collaboration with researchers at Australia’s WEHI, looking into a potentially powerful approach to targeted protein degradation also being studied by its German rival Merck KGaA.
PERTH, Australia – Starpharma Holdings Ltd. is pausing sales of its antiviral nasal spray, Viraleze (SPL-7013), in the U.K. after its retail partner, Lloydspharmacy, received a letter from the U.K.’s Medicines and Healthcare products Regulatory Agency (MHRA) related to promotional claims made about the antiviral with respect to SARS-CoV-2 and COVID-19.
LONDON – The U.K. is setting up a service for developers and users of artificial intelligence (AI) to provide a single source of advice covering all requirements for the technology, from clinical research to regulatory scrutiny, health technology evaluation and through to commissioning.
Avicenna.AI has enjoyed a head-spinning series of regulatory nods for its artificial intelligence (AI)-based solutions for serious vascular conditions including stroke, pulmonary embolism (PE) and aortic dissection. The Marseille, France-based company gained CE mark for its tool that quantifies the severity of a stroke based on a CT scan of the brain and displays regions that have suffered infarcts in late May, followed by CE mark and FDA 510(k) clearance for its product that permits emergency triage of PE and aortic dissection from CT-scan imaging in early June.
Paris – Cardinor AS has secured $1.44 million to commercialize development of a novel ELISA (enzyme-linked immunosorbent assay) blood test that uses secretoneurin as a blood-based biomarker for heart disease and sudden cardiac arrest. London-based Intuitive Investments Group plc participated in this third seed round, along with existing Belgium and German investors.
PARIS – Gleamer SAS said Radiology published compelling results from a study evaluating the performance of its artificial intelligence (AI) system Boneview, which helps radiologists and emergency doctors detect and localize fractures. This is the first study to evaluate the performance of AI-assisted health care professionals in locating bone fractures on all appendicular X-rays.
LONDON – Regeneron Pharmaceuticals Inc.’s antibody cocktail, Regen-Cov, has been shown to significantly reduce mortality in seriously ill hospitalized COVID-19 patients who have failed to mount their own immune response against the SARS-CoV-2 virus. Among these seronegative patients, the casirivimab/imdevimab monoclonal antibody mixture reduced deaths by 20% (p=0.001) in the U.K. Recovery trial.
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