Policy & Regulation

Trump’s second term creates pharma uncertainty. German “free combination” drug rebate faces legal challenges. EU, UK, and Switzerland accelerate clinical trial approvals to regain global research competitiveness and attract biomedical investment.

Trump II, Year One: Updated Version Seems Buggy For Pharma

 
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Issues that had been concerns in Trump’s first term are realities now, but industry has also seen some successes. Trump’s personalistic style of governance means that larger firms may be at an advantage because of their greater flexibility to cut deals on individual products.

EU, UK & Switzerland Speed Up Trials To Regain Global Edge

 
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Amid a decline in global clinical research share, the EU, UK and Switzerland have launched initiatives for fast-track reviews of clinical trial applications and set ambitious targets to shorten trial setup times.

Celltrion USA’s New CMO Champions Regulatory Reform And Access

 
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Juby Jacob-Nara outlines her vision for expanding biosimilar uptake and leveraging policy changes to improve patient access.

Legal Challenges Mount Over Germany’s Controversial Combination Rebate

 

The pharmaceutical industry has been pushing back on a deeply unpopular rebate on products deemed to be “free combination” medicines in Germany.