PARIS – An interdisciplinary academic research consortium in Italy has devised and tested nanowires that restore physiological cell-to-cell conductance. This research team, led by the Experimental and Applied Medical Technology Lab (Tecmed Lab) at the Department of Medicine and Surgery at the University of Parma, Italy, has just published the results of multiple local in situ injections of nanowires into left ventricular infarct regions in Nature Communications.
In one of its familiar U-turns, the U.K. National Institute for Health and Care Excellence (NICE) has recommended NHS England should fund a rare disease gene therapy from Orchard Therapeutics plc, considered to be the world’s most expensive drug. The list price for Libmeldy (atidarsagene autotemcel) in England and Wales is £2,875,000 (US$3.9 million), making it the most expensive drug that NICE has ever evaluated.
PARIS – Spartha Medical SAS reported an award of $2.7 million in grants with further, undisclosed equity financing from the European Innovation Council (EIC) Fund, a body run by the European Commission established to make direct equity investment in European Union companies. This fund will be used to initiate clinical evaluation of its multifunctional coating technique.
University of Edinburgh spinoff Biocaptiva Ltd. is taking its cell free DNA (cfDNA) capture device to clinical trials in 2022 following promising preclinical results. The company’s platform technology is designed to increase the quantity of cfDNA available for liquid biopsy testing. Current liquid biopsy practices obtain cfDNA via a venous blood draw but the concentration of tumor-derived ctDNA can be too low for comprehensive testing. Biocaptiva’ device emerged from research at the University of Edinburgh investigating liquid biopsy technologies.
LONDON – The first human challenge study of SARS-CoV-2 infection has reported initial results, showing it is safe to infect healthy volunteers with the virus in controlled conditions, and paving the way for the model to be used to accelerate clinical trials of COVID-19 vaccines, antivirals and diagnostics.
The U.K. National Institute for Health and Care Excellence (NICE) has endorsed the use of selective laser therapy treatment (SLT) instead of eyedrops as treatment of chronic open-angle glaucoma (COAG) and ocular hypertension. The shift would seem to drive spending in the U.K. away from drugs and toward devices for a condition afflicting nearly 10% of citizens over the age of 75.
Stockholm-based Alex Therapeutics AB is joining forces with pharmaceutical company Pfizer Inc. to roll out digital therapies to patients in Germany. The partnership will utilize Alex Therapeutics' Alex DTx platform for nicotine addiction in Germany. The platform combines cognitive behavioral therapy (CBT) and acceptance and commitment therapy with artificial intelligence (AI) to create treatments for a wide range of psychiatric and somatic disorders.
Blueprint Medicines Corp.’s cancer drug Ayvakyt (avapritinib) looks set to gain an expanded label in Europe, amid a flurry of decisions from the European Medicines Agency’s CHMP scientific committee. Late last week the CHMP gave a positive opinion for Ayvakyt for treatment of adults with advanced systemic mastocytosis, meaning the drug is likely to gain a further European indication in the coming weeks.
LONDON – After six years in development, EMA’s new clinical trials information system (CTIS) was switched Jan. 31, bringing to life a law enacted in 2014 to create a single, harmonized regulatory system across the EU. As the embodiment of the Clinical Trial Regulation, CTIS will underpin a long-awaited simplification of the process for approving trials. Rather than separate applications to different national regulators, a single application delivered via CTIS can lead to simultaneous regulatory and ethics approvals in up to 30 countries.
Galvani Bioelectronics Ltd. reported the first patient implanted with its experimental direct splenic nerve stimulation therapy for rheumatoid arthritis (RA). The first-in-human implant is part of a small trial at the NHS Greater Glasgow & Clyde Health Board in Scotland.
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