Adult immunization programs can save “billions” for society, but their value is underestimated because of challenges around measuring broader value evidence and a lack of incentives for companies to collect this data, says the Office of Health Economics.

US FDA Principal Deputy Commissioner Namandjé Bumpus recently attended a biotech-themed roundtable with the Senate Select Committee on Intelligence and national security officials as Congress’ pulls the FDA into its worries about Chinese influence of the pharma industry.

But that clock is already ticking as the House Oversight and Accountability Committee prepares to mark-up the bill and a likely reconciliation effort with the Senate looming.

The proposed US BIOSECURE Act is heading to a full committee vote amid heightening tensions, underscored by new US Congressional Oversight Committee letters to the FDA asking it to examine national security threats posed by Chinese 'biotechs of concern.'

Association CEO John Crowley tells the Pink Sheet that a survey which found decoupling from China could be disruptive underscores the need to do so because having the supply chain ‘tied up with a global adversary is profoundly worrying to all of us.’

Stay up to date on regulatory guidelines from around the world with the Pink Sheet's Guidance Tracker. The complete Global Pharma Guidance Tracker, with sortable and searchable listings going back to 2014, is available online.

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.

“Incomprehensible” is how the industry group Medaxes describes a new annual tax that Belgium plans to impose on companies to address the costs arising from shortages of medicines.

An EU project has proposed solutions to address key bottlenecks in the approval and conduct of studies that involve the simultaneous investigation of a medicinal product, an IVD and/or a medical device. 

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

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.

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

The ability to quickly scour the internet for comments on drugs may make it challenging to weed out true adverse events from junk as Senate Republicans consider AI-related changes to FDA's authority.

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