Biospectal SA has received a CE MDR class IIa medical device certification for its optical fingertip blood pressure monitoring app, Optibp. The device records fingertip blood flow optically and transforms the information into a pulse wave that it analyzes to estimate blood pressure.

Omini SA hopes that the multiplexed blood testing platform it is developing will transform the lives of patients suffering from heart failure. With its multiplex, sensor-based testing strip that simultaneously measures four key biomarkers from a single drop of blood, the company’s technology should increase the chance of a patient’s survival and reduce pressure on health care systems, Joanne Kanaan, CEO and co-founder of Omini, told BioWorld.

After five years and 350,000 hours of DNA sequencing, the UK Biobank has opened up access Nov. 30 to the whole genome sequences of half a million people who volunteered to give samples 15 years ago.

The U.S. FDA put out a safety warning Nov. 28 that antiseizure drugs levetiracetam and clobazam can cause a rare but serious hypersensitivity drug reaction that may start as a rash but can progress to injure internal organs. In addition, U.K. health care providers are being told to get a plan in place now to implement the first phase of the Medicines and Healthcare products Regulatory Agency’s new regulatory measures  to reduce the risks of valproate, a treatment for epilepsy and bipolar disorder.

Cancer Research UK (CRUK) is worried that rising prices and its total dependence on public donations mean its funding model is becoming unsustainable. The charity is calling on the U.K. government to step in and plug a £1 billion (US$1.23 billion) shortfall it said will open up over the next decade, in order to maintain investment at 2019 levels in real terms.

With hybrid closed-loop systems for automated insulin delivery increasingly being seen as life changing for people with diabetes, Vicentra BV has teamed up with Diabeloop SA and Dexcom Inc. to launch a system to help people with type 1 diabetes manage their condition.

Bioxodes SA has set the stage for the phase IIa study of its novel anticoagulant in the treatment of intracerebral hemorrhage (ICH), after raising a €12 million (US$13 million) series A. Days before announcing the closure of the round, the first patient in the proof-of-concept study was treated, on Nov. 17, and eight of 10 sites across Belgium are geared up to take part in the trial. The aim is to develop the product, Ir-CPI, as the first injectable antithrombotic that is suitable for use within the first 72 hours of an ICH.

The long-running row over the U.K. voluntary scheme that controls the national drugs budget has been settled, in what the industry is describing as a “tough deal.” Under the scheme there is an annual cap on total sales of branded drugs to the National Health Service, with sales over the agreed limit reimbursed via a levy. In 2022, pharma companies paid back £2 billion (US$2.5 billion) in rebates on total sales of £14 billion. In the new five-year agreement, the allowed annual increase in sales will be 2% in 2024, the same as across the current scheme from 2019 – 2023, but it will then increase to 4% by 2027.

In what represents the first Patent Cooperation Treaty filing published in the name of London, U.K.-based Abtrace Ltd., the company’s co-founder and chief executive officer, Umar Naeem Ahmad, collaborates with Xavier Monnet – professor of intensive care at Assistance Publique - Hôpitaux de Paris (APHP) Université Paris-Saclay – on the design of a fluid delivery system for delivering intravenous fluid therapy to a patient.

With a landmark U.K. approval in hand for Casgevy (exagamglogene autotemcel [exa-cel]) to treat sickle cell disease and transfusion-dependent beta thalassemia, Crispr Therapeutics AG and partner Vertex Therapeutics Inc. are turning their attention to the PDUFA dates set by the U.S. FDA for the treatment in both conditions.