Before J&J’s former chief data scientist Najat Khan moved to Recursion, she talked to the Pink Sheet about how AI is transforming trials and driving collaboration between industry and regulators.

Pink Sheet reporter and editors discuss what an upcoming listening session means for the FDA’s advisory committee reform effort, the agency’s efforts to help clinical trial modeling and simulation, and the UK’s MHRA plan to use artificial intelligence to assist in drug reviews.

Compliance functions will be moved to the product centers when ORA becomes the Office of Inspections and Investigations, and centers will become responsible for making the final agency decision on inspection classifications, Associate Commissioner Michael Rogers said.

The European Parliament has voted for a deal agreed with the council of minister to ensure polluters pay for cleaning up urban wastewater.

The Swiss agency says the aim of the agreement is to bring “high-quality, life-saving medicines to patients as quickly as possible.”

The FDA’s drug center has all but stopped holding meetings at this point, which begs the question: why do they want advice on how to make them better?

The mechanics of implementing the new prices is the most significant update in the draft. The few revisions to key elements of the negotiation process in the guidance include alternative approaches to forums for collecting patient input on the selected drugs. 

The schedule for the second round of negotiations is different from the first cycle, in part because the Inflation Reduction Act allowed for extra time initially as the program launched. The first- and second-year timelines also overlap: The second negotiation cycle will begin before the first cycle prices are implemented. 

The European Parliament has voted for a deal agreed with the council of minister to ensure polluters pay for cleaning up urban wastewater.

Novo Nordisk is expecting a relatively modest uptake in Medicare Part D for the cardiovascular claim, but plans still will worry about stemming demand in obesity.

The new tool provides a way of quantifying the degree of diversity by race/ethnicity, sex and age in clinical trials, but the results will not factor into the US health technology assessment body’s cost effectiveness determinations for new drugs.

Shionogi’s UK general manager praised NHS England’s novel subscription model for antibiotics, but warned the country would be “wasting money” unless other global regulators introduced similar incentives for antimicrobial development.