LONDON – Industry-sponsored clinical research in the U.K. took a big hit in the pandemic and is still struggling to catch up – and to capitalize on innovative trial designs and delivery approaches that were so successful in speeding up COVID-19 studies.

LONDON – Industry groups, patients’ representatives and clinicians have launched the European Alliance for Cardiovascular Health (EACH) to lobby for a comprehensive EU policy to address the increasing burden of cardiovascular disease.

Illumina Inc.’s troubled takeover of Grail Inc. is facing further backlash from the European Commission (EC) after the regulator issued a statement of objections to the companies following their alleged breach of the EU Merger Regulation. Illumina’s acquisition of Grail has faced scrutiny from regulators since it was first announced due to concerns the deal could curb innovation and competition.

A second activist investor has questioned the leadership of Glaxosmithkline plc’s CEO Emma Walmsley, after Bluebell Capital Partners Ltd. took a reported £10 million (US$13.7 million) stake in the embattled U.K. pharma.

The U.K. government has doubled down on its overarching strategy for artificial intelligence (AI) with a 10-year plan to sustain the nation’s place in the global AI race. One of the key considerations in this plan is to revisit the criteria for status as an inventor, a clear nod to the dilemma presented by proponents of allowing the DABUS algorithm to be named as an inventor.

The U.K. National Institute of Health and Care Excellence (NICE) has examined the evidence for the use of mitral valve-in-valve procedures and found the evidence for safety is well rounded despite concerns about several complications.

LONDON – A pan European research project is working with manufacturers and clinicians to set measurement standards that will transform magnetic resonance images from 2D and pictorial, to 3D and quantitative, significantly increasing their diagnostic power. The project, led by the U.K. metrology body, the National Physical Laboratory (NPL), aims to introduce consistency and specificity for diagnosing specific conditions, by setting independently verifiable ways of noninvasively measuring lesions and the composition of different tissues and organs.

While European health care systems have historically lagged the U.S. in terms of digital adoption, a report by investment firm Albion VC is highlighting how the pandemic has created the momentum for change.

The med-tech regulatory picture is already in a state of flux thanks to changes imposed by the EU, but device makers and those in the digital health space might soon be facing yet another series of profound changes in Europe. The U.K. Medicines and Health Care Products Regulatory Agency (MHRA) has proposed to revamp its regulatory framework for both traditional medical device and for software/artificial intelligence, adding yet more uncertainty to an already turbulent European regulatory environment.