Each week we highlight five things affecting the life sciences industry. Here’s the latest.
U.S. caps Swiss tariffs at 15% in pharma trade deal
- The U.S. and Switzerland reached a trade agreement that caps import tariffs on Swiss and Liechtenstein goods—including pharmaceuticals—at 15%, aligning with terms the U.S. made with the European Union.
- Previously, the U.S. had imposed some of the highest global import tariffs—around 39%—on Swiss goods, and this new deal also encourages Switzerland to invest at least $200 billion in U.S. manufacturing and research and development over the next five years, reports Fierce Pharma.
Leadership shake-up sparks concern at U.S. drug regulator
- The Guardian reports that the abrupt exit of the agency’s top drug-review official has intensified internal tensions and raised questions about leadership stability.
- Observers warn that this turmoil could weaken review consistency and erode public confidence in the broader health care oversight system.
Regulatory gains, patent obstacles keep biosimilar promise on hold
- The U.S. Food and Drug Administration has proposed updated guidance to accelerate the development of biosimilar drugs, potentially halving time and cost for market entry.
- Per KFF Health News, despite regulatory progress, a dense “patent thicket” and restrictive challenges by the United States Patent and Trademark Office are still blocking many biosimilars from reaching patients.
New biotech hub set for Philadelphia
- A new 44,000-square foot innovation and lab-space site will open in Philadelphia, offering wet labs and infrastructure for early-stage biotech firms, reports PR Newswire.
- This expansion builds on a network of similar centers designed to accelerate early drug-development efforts and foster collaboration among biotech entrepreneurs and researchers.
EU pilots coordinated review of medtech trial filings
- A group of European Medicines Agency member states have launched a pilot program to conduct jointly coordinated assessments of clinical investigations and performance studies for medical-device and in-vitro diagnostic trials.
- Regulatory Affairs Professionals Society reports that the initiative aims to streamline cross-border review processes and reduce duplicative regulatory burdens across the EU’s medtech industry.
For more insights in life sciences, check out RSM’s industry outlook.
