The US FDA is eager for Congress to address critical factors contributing to chronic generic drug shortages, but elected officials often are more focused on special cases like obesity drugs and ADHD treatment where the answers are very different. 

NeuroSense plans to adjust its upcoming clinical trial to avoid the fate of Amylyx’s ALS candidate, which was recently withdrawn from the market due to a lack of efficacy.

Pink Sheet editors and reporter consider the implications of the BIOSECURE Act as it advances through a House committee, whether industry would improve clinical trial diversity with tougher enforcement of the regulation, as some have suggested, and the FDA’s use of platform technology ideas for gene therapies not participating in the program.

In the third of a series of articles on the European Parliament’s changes to the planned reform of EU pharmaceutical legislation, the Pink Sheet looks at how the amended proposals on notifying drug shortages could impact companies, regulators and wholesale distributors.

The Medicines and Healthcare products Regulatory Agency has introduced a series of changes, including an upcoming overhaul of its clinical trial legislation, to enhance its performance in the future, chief executive Dame June Raine writes.

Dynamic regulatory assessments, also known as rolling or phased reviews, could see medicines granted marketing authorizations more quickly, but the EU is lagging behind the US and UK in implementing them, Gilead’s EU regulatory policy lead has said.

Rahul Rao, the deputy director of the FTC Bureau of Competition, discussed the agency’s thinking on recent pharma deals that it viewed as anti-competitive.

The agency says it will collect additional information from manufacturers on methods for adding up price concessions from the supply chain before moving ahead.

Industry leaders and experts at the Financial Times Pharma and Biotech Summit said the US relationship with China adds pressing risk to pharma.

The deal comes at a time when Latin American countries are increasingly looking to improve the regulatory environment for pharmaceuticals and move towards greater convergence.

Pink Sheet infographic details the timeframes and potential extensions under the House version of the bill, which just cleared committee.

Industry groups say the initiative will undermine innovation and the competitiveness of European companies, impeding Europe's ability to tackle future crises effectively.