North America

Aragen’s CEO Manni Kantipudi, who is keenly watching the Trump Administration’s moves on pharma tariffs, discusses funding cuts at the National Institutes of Health, big pharma’s US onshoring moves, and talks with the Indian government to solve intellectual property challenges in an interview.

FDA Commissioner Martin Makary said in an interview that he will use the current structure to reform the agency. He also plans to address employee morale.

The mood at the World Vaccines Congress in Washington, D.C. was bleak given Robert F. Kennedy Jr.’s rise to lead the Trump Administration’s Health and Human Services Department, but vaccine lawyers offered an optimistic outlook and ideas for countering his vaccine agenda.

Failing to meet the 29 April user fee date for the Barth syndrome treatment, and CDER’s request for a delay in responding to Vanda’s appeal of a tradipitant complete response letter, suggest a slowdown in review work due to layoffs and other recent changes.

An initiative run by health technology appraisal (HTA) bodies in the US, Canada and England is looking at how non-traditional treatment benefits, such as the value of hope and scientific spillover, can inform appraisals and understanding of a product’s value.

The Canadian regulator says its current policy on identifying and labeling drug products in “kits” is insufficient to address the diverse types of co-packaged drug products that are entering the market.

Canada’s new guidance on rare disease registries is based on international guidelines, but in some areas there remains work to ensure that implementation of some recommendations is feasible in the Canadian context.

As part of efforts to modernize its clinical trials framework, the Canadian regulator is looking to better facilitate expanded access clinical trials, which allow investigational drugs to reach patients with serious conditions before they are approved.