Following an investigation into Leadiant Group’s pricing of a rare disease drug, the Italian Competition Authority fined the privately held company about €3.5 million (US$3.76 million) May 31 for charging the Italian National Health Service excessive prices since 2017 for Chenodeoxycholic Acid Leadiant.

Healiva SA, a Swiss wound care specialist, emerged from stealth mode having acquired two cell therapy assets from Smith & Nephew plc. Financial terms were not disclosed, but they included an up-front payment as well as “deferred benefits,” Healiva CEO and founder Priyanka Dutta-Passecker told BioWorld. The deal means that the Lugano-based company – which was formed in 2020 – could be booking revenues as early as 2023.

Vitestro BV is preparing for pivotal clinical studies of its automated phlebotomy device after unveiling the prototype to clinicians in the Netherlands.

Less than three years after unveiling the first Sonovein device, Theraclion SA is launching its CE-marked, third-generation platform, Sonovein HD. This represents a new generation of robotics platform for noninvasive treatment of varicose veins. The new version integrates the acquisition and analysis of technical data during the procedure.

Volitionrx Ltd. won the CE mark for its Nu.Q NETs test for the detection, evaluation and management of NETosis, a type of cell death characterized by the release of neutrophil extracellular traps, or NETs. The test – the first biomarker approved for the measurement of NETs for patient management – will soon be available for clinical use across the E.U.’s 27 member states.

Facing the global threat of antimicrobial resistance (AMR), the EMA issued a final revised guideline on the evaluation of new antibiotics. In accordance with an agreement with the U.S. FDA and Japan’s Pharmaceuticals and Medical Devices Agency, the EMA’s guideline aligns as much as possible with the data requirements of those regulators so drug developers can design clinical trials that meet the evidence needs of all three agencies, the EMA said.

“The incomplete in vitro diagnostic regulation (IVDR) poses critical ongoing risks that need urgent resolution,” said Medtech Europe, as it welcomed the coming into force of the new EU regulatory system on May 26. Five years since the publication of the regulation, and after the industry has invested “significant resources into complying with its requirement,” some key elements of the infrastructure “are still not fully operational or even in place,” according to the trade body. “It is critical that all needed infrastructure is put in place and made operational without delay,” said Serge Bernasconi, CEO of Medtech Europe.

Lumiradx Ltd. has secured CE marking for its HbA1c test for diabetes. The point-of-care (POC), automated fingerstick assay is run on the Lumiradx portable platform and designed to provide connected results in under seven minutes, with a reportable range of 20-130 mmol/mol HbA1c (4.0% to 14.0% HbA1c).

Facing the global threat of antimicrobial resistance (AMR), the EMA issued a final revised guideline on the evaluation of new antibiotics. In accordance with an agreement with the U.S. FDA and Japan’s Pharmaceuticals and Medical Devices Agency, the EMA’s guideline aligns as much as possible with the data requirements of those regulators so drug developers can design clinical trials that meet the evidence needs of all three agencies, the EMA said.

Medtech Europe, the European trade association for the medical technology industry covering diagnostics, medical devices and digital health, has just adopted a new code of ethical business practice.