NeuroSense plans to adjust its upcoming clinical trial to avoid the fate of Amylyx’s ALS candidate, which was recently withdrawn from the market due to a lack of efficacy.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

At a Senate subcommittee hearing, the FDA commissioner says advisory committees remain important but need to be “meeting the purpose for which they exist.”

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 FDA commissioner said an H5N1 vaccine can be developed from the same mRNA platform used to create the COVID-19 vaccines, but funds are needed to ensure production can begin quickly if a human outbreak occurs.