Uniqure NV is the latest firm to get caught between the FDA’s shifting demands for “gold standard” science and regulatory flexibility for rare disease therapies. The company disclosed in its latest earnings report that U.S. regulators are calling for a sham-controlled study before they will consider approval of gene therapy AMT-130 in Huntington’s disease, a requirement that could set the program back by two to three years and raises potential ethical issues.

In an all-cash transaction valued at €780 million (US$920 million), Asahi Kasei Corp. offered to buy Aicuris Anti-infective Cures AG, expanding its infectious disease portfolio with a marketed cytomegalovirus product and a herpes treatment nearing an NDA.

GSK plc will pay Frontier Biotechnologies Inc. $40 million up front and up to $963 million in milestone payments to license two of Frontier’s small interfering RNA-based assets in the field of immunology.

This year, European med-tech companies continue to navigate an uncertain macro environment created by the reciprocal tariffs on goods entering the U.S., their primary market. Some companies though are adapting supply chains and manufacturing strategies, while others are looking to diversify into other regions. Their technologies after all, address clinical needs, so the sector continues to innovate, conduct trials, present data, raise funds, and deliver products which improve patients’ lives.

Coming off a U.S. FDA approval of the first GLP-1 in pill format, Novo Nordisk A/S leaned further into oral drug delivery efforts, partnering with Vivtex Corp. to develop next-generation oral formulations of peptide and protein therapeutics in a potential $2.1 billion deal that marks the highest-profile news for Vivtex since the firm spun out of MIT in 2018.

GSK plc is paying $950 million cash to acquire 100% of 35Pharma Inc.’s equity and pipeline, including phase II-ready candidate HS-235 for pulmonary hypertension. The acquisition agreement comes a day after GSK added two small interfering RNA assets from Nanjing, China-based Frontier Biotechnologies Inc. through a license deal reaching up to $1 billion.

Neurosoft Bioelectronics SA has signed an agreement with Science Corp. to gain access to its full stack of clinical-grade neural recording tools as it looks to advance its brain-computer interface (BCI) system.

The ramifications of the U.S. Supreme Court’s decision Feb. 20 that shot down President Donald Trump’s reciprocal tariffs issued under the International Emergency Economic Powers Act are rippling across the world. And Trump’s immediate response to that ruling – a proclamation imposing a temporary 10% import duty on most goods brought into the country beginning Feb. 24 – isn’t helping.