Citing the “totality of data,” Sanofi SA plans to file global regulatory submissions this year for amlitelimab in atopic dermatitis, despite mixed results from two additional phase III trials testing the OX40-ligand (OX40L) inhibitor the pharma firm has been positioning as a potential successor to its Regeneron Pharmaceuticals Inc.-partnered blockbuster, Dupixent (dupilumab).

Four years after they were first mooted, the finishing line is in sight for new U.K. clinical regulations, which will come into force on April 28. In the first major update since 2004, about 20% of lower-risk studies are expected to be approved by a fast track, and the Medicines and Healthcare products Regulatory Agency will introduce a 14-day assessment route for phase I healthy volunteer trials, amongst other measures to streamline approvals.

Researchers have developed an AI-based wearable device, called Revoice, to help individuals communicate effectively after a stroke. The system, worn around the neck, uses sensors to capture carotid pulse signals and subtle vibrations from throat muscles to reconstruct intended words and sentences in real time, potentially transforming the lives of stroke patients living with dysarthria.

Prenaital ApS has filed a patent for technology that may identify risks of spontaneous pre-term birth. Spontaneous preterm birth (sPTB) is usually defined as birth occurring before 37 weeks of gestation. The invention relates to a method for predicting potential preterm birth from medical scan data, which may be used in practice by medical professionals for risk analysis and prognosis of potential pathologies.

The economic and societal implications of the underfunding of women’s health finally reached the agenda of the World Economic Forum (WEF), with the launch at the 2026 annual meeting in Davos, Switzerland, this week of the inaugural Women’s Health Investment Outlook. The neglect of women’s health is not only a public health issue, but also “a market inefficiency on a global scale,” the WEF report said.

A team of international researchers is investigating whether a finger-prick blood test could be used to help diagnose Alzheimer’s disease before symptoms appear. With current diagnostic methods relying on expensive brain scans and invasive lumbar punctures, the trial is exploring whether the simple test could offer a faster, cheaper, and more accessible route to identifying the disease.

The European Commission recently published the results of a study of the impact of the EU regulatory environment, which confirmed the worst fears of some observers about the situation in the EU. The report said that the associated challenges are prompting small and medium companies to pull at least one product out of inventory for the EU market, with some companies abandoning the EU altogether.

A trio of European cancer vaccine specialists have filed progress reports, with advances in technology and targeting, fresh infusions of cash, and off-the-shelf products moving into the clinic. Six years on from its formation, Ervimmune closed a series A at €17 million (US$19.9 million) to drive forward clinical development of lead program Ervac-01. Accession Therapeutics Ltd. raised a further £30.5 million (US$40.4 million) from its existing investors, following dosing of four patients with Trocept-01. And Infinitopes Ltd. added $15.4 million to its seed round, as it finalizes preparations for a phase I/IIa trial of the lead product ITOP-1.

Boston Scientific Corp.’s intent to acquire Penumbra Inc. for $14.5 billion will not only allow it to expand its minimal invasive care portfolio in areas such as embolization and peripheral vascular disease, but to also reenter the neurovascular space, Kathleen Van Vlierberghe, vice president of Peripheral Interventions EMEA, told BioWorld.

The U.K.’s National Institute for Health and Care Excellence is revisiting its policy for osteoporosis and may recommend that clinicians include vertebral fracture assessment with dual energy X-ray absorptiometry procedures.