North America

Amgen, BMS, Boehringer Ingelheim, Genentech, Gilead Sciences, GSK, Merck, Novartis and Sanofi will reduce prices of some drugs for Medicaid and offer cheaper prices through direct-to-patient platforms, among other concessions, and receive tariff exemptions.

The US FDA’s cell and gene therapy group has “scores” of active INDs using AI, and is eager to see it grow, but challenges remain with employing AI for decision-support tools, including the lack of good quality datasets to train models.

After conducting more than 30 meetings for drugs, biologics and related issues in 2023 and 2024, less than half as many were held in 2025.

The US Centers for Medicare and Medicaid Services argued gender affirming care is not health care to help justify the new proposed rules. The argument could create a new opening for the federal government to go after other pharmaceuticals.

Regulators in the US and Canada are working together to streamline approval timelines for generic drugs through a voluntary information sharing program.

An early negotiation process for certain cancer drugs could cut pricing negotiation times by up to six months, while a targeted process for non-complex drug negotiations could lead to timelines that are 30–45% faster than standard negotiations.

Clinical trial sponsors could soon benefit from a streamlined clinical trial approval process in Australia, Canada, Singapore, Switzerland and the UK under a new ACCESS Consortium project.

Canada’s drug regulator is using amended drug laws to increase the use of regulatory reliance pathways to improve efficiency and support international alignment, while the UK’s MHRA has held talks with Australia’s TGA on topics including the role of AI in regulatory frameworks.