Patients with chronic spontaneous urticaria who remain symptomatic despite H1 antihistamine treatment now have a new oral treatment option, with the U.S. FDA’s approval of Novartis AG’s Rhapsido (remibrutinib), a Bruton’s tyrosine kinase inhibitor administered by pill twice daily.

Ernst & Young LLP didn't quite declare the patient cured but saw signs of a strong med-tech recovery after a few years on life support in its annual Pulse of the MedTech Industry report. The global accounting giant particularly called out strength in the cardiovascular, diabetes, robotics and orthopedics segments.

Roche Holdings AG reported results from its TSIX study which demonstrated that its sixth-generation Troponin T test is accurate at diagnosing heart attacks not only in men but also women. Recently granted CE mark, the Elecsys Troponin T hs Gen 6 test, demonstrated it was able to identify acute myocardial infarction (AMI) and identify those not having an AMI, with a high level of precision, ensuring that patients receive the care they need at the earliest opportunity.

Sovargen Co. Ltd. inked a $550 million license deal with Angelini Pharma SpA, granting Angelini development and commercialization rights to SVG-105, a novel antisense oligonucleotide drug candidate in preclinical development as a potential treatment for intractable epilepsy.

The threat of tariffs on imports of branded drugs is about to be realized after U.S. President Donald Trump announced a 100% import duty will apply beginning Oct. 1. However, the flurry of recent announcements by pharma companies of investments in U.S. manufacturing plants may have paid off, with the president saying in his announcement on Truth Social that the 100% rate will be enforced “unless a company is building their manufacturing plant in America.”

Rhythm Diagnostic Systems SAS (RDS) raised €14 million (US$16.6 million) in a series A funding round for Multisense, its wearable device that continuously monitors key physiological parameters of patients in hospital or at home. Already CE-marked and deployed in approximately 15 hospitals across France, Belgium and Germany, the funds will enable RDS to expand its commercial and customer support teams and prepare reimbursement filings in key European markets, Elie Lobel, CEO of RDS, told >BioWorld.

The U.K. National Institute for Health and Care Excellence unveiled a plan that is designed to provide less cumbersome market access for medical technologies.

Genmab A/S is paying $8 billion to acquire Merus NV, gaining rights to the latter’s phase III-stage petosemtamab, a bispecific antibody initially in development for head and neck cancer, and continuing the firm’s strategy to transition from a royalty-based operation to a fully integrated biopharma.

A month after raising $55 million to advance its AI-enhanced ultrasound diagnostics for cardiovascular disease, Ultromics Ltd. presented strong results for its U.S. FDA-cleared AI analysis of echocardiograms at the American Society of Echocardiography's 2025 Scientific Sessions in Nashville, Tenn. Ultromics' Echogo Amyloidosis was able to detect cardiac amyloidosis earlier and more accurately than traditional methods, missing fewer cases without increasing unnecessary testing.