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.
PERTH, Australia – Australia attracted international attention in July when a Federal Court ruled that artificial intelligence can be named as the inventor of a patent. In Thaler v. Commissioner of Patents, Federal Court Justice Jonathan Beach ruled that under Australian patent law, inventors don’t necessarily have to be human. The decision challenges the assumption that only human beings can be inventors. Beach did rule, however, that an AI system cannot apply for a patent or receive a patent.
LONDON – The confluence of Brexit and pandemic has hit regulators in Europe hard this year, with the workload of assessing COVID-19 vaccines and antivirals made all the more onerous by the loss of expertise suffered by both the EMA and the U.K. Medicines and Healthcare products Agency (MHRA) as their close relationship was severed.
PARIS – Orixha SAS raised $2.25 million to bolster development of its Vent2cool medical device, pulmonary ventilation technology used in critical care settings. Investment company Erganeo SAS, the Angels Santé business angels group and three French industrial partners – Infiplast SAS, OEM Development SAS and Activation SAS – all participated in the round.