Regulation

US President Trump’s plan for a “25% or higher” tariff on pharmaceuticals promises to have a far-reaching impact, from higher prices and drug shortages to increased onshoring of manufacturing in the US. Is MAGA worth the chaos it might create for MAHA? The Indian industry shares its views.

Two investigational products have made it onto the European Medicines Agency’s priority medicines scheme so far this year. Meanwhile, of the 14 products that entered the scheme last year, six were advanced therapies.

Argenx has discontinued Vyvgart for the rare skin disease as other potential candidates linger in the very early stages of development.

As many as 700 employees reportedly dismissed from posts starting on 14 February as the culling of the federal workforce by the Trump administration’s Department of Government Efficiency reaches FDA.

A list of EU biosimilar filings, CHMP opinions and EU marketing authorizations, including details of the biosimilar company, the brand name/INN, indication(s), the reference product/company, and the date and type of event.

The Pink Sheet's list of EU centralized approvals of new active substances has been updated to include nine new products, one of which is Kostaive (zapomeran), CSL/Arcturus Therapeutics’ self-amplifying mRNA COVID-19 vaccine for individuals 18 years and older.

Parexel's CEO Peyton Howell and India boss Sanjay Vyas talk to Scrip about the value of clinical trial diversity, AI pilots underway and opportunities for India amid geopolitical rumblings, as well as the need for standardized regulatory approaches to enhance sponsor interest.

President Trump's Executive Order creating the commission names mental health and weight-loss drugs as treatments of concern. But it does not mention vaccines, which Kennedy has criticized.

The European Medicines Agency believes its plan to develop guidance for reporting and evaluating mechanistic models used for MIDD would also benefit from input from other regulatory agencies, such as those in the US, Japan and Canada.

Trade groups say they welcome working with Robert F. Kennedy Jr. on expanding and improving consumer access to OTC drugs and dietary supplements. White House “Department of Government Efficiency Workforce Optimization Initiative” limits filling federal agency vacancies.