The European Commission (EC) posted a new explanatory note on Tuesday that provides guidance on the codes set under the European In Vitro Diagnostic Regulation (IVDR) to define the notified body (NB) scope of designation and qualification required for assessing a device. The clarifications explain how to use the different levels of codes to guide the proper allocation of resources, citing the anticipated challenges with limited experience and competency of NBs.
Europe’s clinical trial registry is a mess with patchy and incomplete data, according to a scathing review of the system from researchers based at the U.K.’s University of Oxford, who hope that a revamp at the end of the year could improve matters.
PARIS ‒ Kiomed Pharma SA reported it has signed an exclusive agreement with fellow Belgian company, Moveup SA for the development and licensing of a mobile companion application intended for personalized conservative management treatment for patients suffering from intra-articular osteoarthritis.
NICE has said “no” to regular NHS funding for a rare disease gene therapy from Orchard Therapeutics Ltd. in draft guidance – although experience from Novartis AG’s pricey Zolgensma (onasemnogene abeparvovec) for spinal muscular atrophy shows this could change. That’s because this week NICE published final guidance that recommends funding for Zolgensma, thought to be the world’s most expensive drug, after an initial rejection late last year.
LONDON – The U.K. intends to take the positives from its response to the COVID-19 pandemic as a blueprint for developing treatments for a range of other diseases and the basis for a new 10-year strategy for the life sciences.
LONDON – Final results of the community pilot in Liverpool, U.K., that used the controversial Innova Medical Group Inc. lateral flow device to test all comers for COVID-19, show new cases fell by 21% compared to other areas of the U.K., because infections were detected early and people quarantined sooner.
DUBLIN – Bacteriophage, like other viruses, can be viewed as complex molecular machines with two essential functions: infection and replication. The first involves the efficient injection into the host cell of their genomic payload; the second involves hijacking the host’s nucleic acid replication machinery to generate the functional and structural proteins needed to give rise to progeny viruses.
Getting cell therapies to work against solid tumors is proving difficult – but two biopharma firms have begun early-stage studies with technologies that aim to crack this tough nut. Gadeta B.V. and Apeiron Biologics AG are using two different approaches to cell therapy that they hope will be effective against tough-to-treat solid tumors.
PARIS – One year on from launch, Digitale Gesundheitsanwendungen (DiGA), or digital health applications, are gaining widespread acceptance in Germany. Digital therapeutics (DTx) have been available since 2020 to the 73 million people in Germany covered by public health.