There is a growing body of evidence showing prescription digital therapeutics (DTx) are effective, but slow progress in agreeing reimbursement and integrating them into care pathways is limiting access for patients and holding back commercial development in Europe.

Novo Nordisk A/S has entered into exclusive negotiations for a controlling stake in Biocorp SA, suppliers of Mallya, a Bluetooth-enabled smart add-on device for insulin pen injectors. The takeover will be phased over several stages. Novo Nordisk has initially negotiated with Bio Jag SAS, Biocorp’s principal shareholder, to purchase its entire stake in Biocorp, representing 45.3% of the share capital and 62.19% of the voting rights. Certain minority shareholders, including Nyenburgh Holding BV, Greenstock EIG and Vatel Capital SAS, who together account for 19% of Biocorp’s shares, have agreed to transfer their shares to Novo Nordisk once acquisition of the Bio Jag stake is complete.

The EMA and the European Center for Disease Control have said COVID-19 vaccine manufacturers should ditch the existing formulations and adapt their products to target the omicron-descendant XBB.1.5, to protect against SARS-CoV-2 in the winter of 2023–2024.

Avacta Group plc has continued its growth through M&A strategy with the acquisition of Coris Bioconcept Sprl, a developer of rapid diagnostic test kits, for an up-front cash consideration of £7.4 million (US$9.3 million). The Coris deal comes on the back of its £24 million purchase of Launch Diagnostics Holdings Ltd last year, as Avacta works on building up its diagnostics division.

In a new health technology assessment, the U.K. National Institute for Health and Care Excellence (NICE) has voiced misgivings about the evidence behind the use of MRI/ultrasound fusion systems to perform needle biopsy for suspected prostate cancer. NICE said the evidence for these systems could be bolstered by additional research comparing fusion biopsy to cognitive fusion-directed biopsy, suggesting that companies working in this space have a significant evidentiary lift in front of them.

The U.K. government should speed up the approval process for medical devices and strengthen the Medicines and Healthcare products Regulatory Agency, as there is an opportunity for the country to provide global leadership in life sciences regulation in medical devices and medicines on the back of Brexit, according to a report.

Otsuka Pharmaceutical Co. Ltd. has gone back on efforts to get its medicine, Asimtufii (aripiprazole), a long-acting maintenance treatment for schizophrenia, approved in Europe, after the EMA gave a provisional negative opinion.

Tissium SA reported the close of a series D funding round, raising $54 million from investors both new – such as Mérieux Développement SAS – and long-term, including Cathay Capital Co. Ltd., Crédit Mutuel Innovation SAS and original investors, Sofinnova Partners SAS.

The U.K. government has announced £121 million (US$148 million) in funding to reboot the commercial clinical trials system after a sharp decline saw the number of industry-sponsored studies falling by 44% from 2017 to 2021.

Otsuka Pharmaceutical Co. Ltd. has gone back on efforts to get its medicine, Asimtufii (aripiprazole), a long-acting maintenance treatment for schizophrenia, approved in Europe, after the EMA gave a provisional negative opinion.