The U.K. Medicines and Healthcare Products Regulatory Agency (MHRA) has unveiled two guidances for the use of real-world evidence (RWE) in regulatory decision-making. The policy seems limited to pharmaceutical clinical trials, with no indication when it will be expanded to include medical technology.
The effect of the COVID-19 pandemic on the roll-out of European Union’s new med-tech regulations has sparked concerns about in vitro diagnostic availability, but relief from compliance deadlines has now been achieved. The European Parliament and the European Council have agreed to ease the compliance dates of the In Vitro Diagnostic Regulation (IVDR).
Bond Digital Health Ltd. landed £1 million (US$1.3 million) from investors to expand development of its Transform data management system for lateral flow diagnostic tests. The technology connects to an app that captures data from lateral flow assays in self-testing settings. The results are then shared to a dashboard that can be monitored by the platform admin. The new investment included equity funding from the Development Bank of Wales and high-net-worth investment service Wealth Club. In addition to the current round, Bond is aiming to raise a further £500,000 by January.
Following extensive discussions with their British counterparts, the European Commission (EC) advanced proposals to ensure the continued long-term supply of medicines from Great Britain to Northern Ireland and to address supply concerns in Cyprus, Ireland and Malta, which historically have been dependent on drugs from the U.K.
The U.K.’s National Institute for Health and Care Excellence (NICE) will welcome a new chief executive in February. Samantha Roberts was named to succeed Gillian Leng, who is retiring after 20 years at the agency. With extensive experience in health care delivery and as a clinician, Roberts currently serves as managing director for health and care at NHS England.
The European Council reached an agreement Dec. 20 that will allow the European Health Emergency Preparedness and Response Authority to respond much more quickly to public health emergencies such as the COVID-19 pandemic by activating urgent and targeted medical countermeasures (MCMs) across the EU.
Vicentra BV has closed a $74 million series C financing round to accelerate the European rollout of its wearable insulin patch. The small, lightweight system Kaleido is the company’s flagship product and consists of two pumps controlled by a Bluetooth wireless connected handset. The small size rests on a pumping action that – unlike a conventional syringe mechanism – uses micro-pulse technology to deliver accurate and consistent doses of insulin.
DUBLIN – The EMA has rejected Biogen Inc.’s application for European Union approval of Aduhelm (aducanumab), its controversial Alzheimer’s disease drug. Its human medicines committee (CHMP) issued a negative opinion on Biogen’s dossier during its December meeting this week, stating that the data from the key studies submitted in support of the application “were conflicting and did not show overall that Aduhelm was effective at treating adults with early stage Alzheimer’s disease.”
PARIS – Dyameo SAS has successfully raised $1.13 million in seed funding to develop its endoscopy probe used for the instantaneous detection of cancerous cells. This round was led by Medevice SAS and Aquiti Gestion SAS via its co-investment fund, NACO.
Depixus Ltd. has raised $35.4 million in an oversubscribed series A financing to push commercialization of its Magna multiomics system. The series A round was co-led by Lansdowne Partners and PSIM Fund, with participation from Casdin Capital and existing investor Arix Bioscience. The funds bring the company's total equity and grant funding to more than $47 million.
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