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The U.K.’s National Institute for Health and Care Excellence (NICE) is playing catch-up after seeing its workflow disrupted by the COVID-19 pandemic and has made the first funding approval using a new fast track appraisal process.
LONDON – The U.K. has set up the first randomized controlled trial of COVID-19 vaccines in pregnant women, to assess different dosing schedules. The aim is to find the balance between longer intervals that are known to spur a greater immune response, against shorter intervals that provide faster protection.
The U.K.’s Competition and Markets Authority (CMA) hit Advanz Pharma Corp. Ltd. and two private equity firms July 29 with fines totaling more than £100 million (US$139 million) for increasing the price of a thyroid drug by more than 6,000% since 2007.
PARIS – At some point, scientists reported, it may be possible to quarantine viruses rather than humans. For the last two years, European research consortium Virofight has been working on a form of nanotechnology intended to neutralize viruses such as SARS-CoV-2, HIV, influenza and hepatitis viruses.
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.
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