US

Sanofi’s voluntary Dengvaxia withdrawal due to low demand leaves the US with no dengue vaccine, even as Puerto Rico declares a public health emergency and global cases rise.

However, the US FDA’s approval of donanemab comes with little guidance on when to stop treatment or when the anti-amyloid agent may need to be restarted in Alzheimer’s patients.

With the sheen of inevitability now scuffed off the BIOSECURE Act, diplomatic efforts to reduce US dependence on Chinese APIs are increasing in prominence. And the power of the legislation itself could be determined by litigation about a video app.

US FDA trial enrollment data show improving enrollment across broad demographic definitions, but stakeholders agree more attention is needed for complex subgroups. Could larger trials be part of the answer?

Commissioner Robert Califf urged a change in clinical trial diversity discussions, emphasizing the need to consider the realities of US leadership in a global drug development ecosystem.

US FDA review divisions will determine whether the meeting is appropriate because there are no one-size-fits-all requirements.

Pink Sheet reporter and editors discuss what the FDA included in its long-awaited guidance on clinical trial diversity action plans, along with what was left out, as well as an upcoming guidance on the use of artificial intelligence in regulatory decision-making.

Rocket Pharmaceuticals’ gene therapy Kresladi, Daiichi Sankyo/Merck’s patritumab deruxtecan, and AbbVie’s foscarbidopa/foslevodopa (ABBV-951) received CRLs because of manufacturing concerns.

The Supreme Court’s 6-3 ruling is expected to have a minimal impact on drug approvals and other scientific determinations, but matters steeped in the interpretation of regulation and statute, such as marketing exclusivity, could face a heightened risk of challenge, legal experts say.

Sun’s deuruxolitinib and Novo Nordisk’s insulin icodec stand out as new molecular entities among the small cluster of US FDA user fee goal dates in July.

The CDC's Advisory Committee on Immunization Practices voted for a universal COVID-19 vaccine recommendation for 2024-2025, but said the decision would have been easier with a lower-cost product.

In a 5-4 decision, the high court says a Chapter 11 bankruptcy plan provision releasing the Sackler family from future liability is not allowed, a decision that could spur a bolus of personal injury trials if another reorganization plan settling thousands of claims cannot be reached.

The significantly scaled back version of the Treat and Reduce Obesity Act is expected to cost the Part D program $1.7bn over 10 years.

The unpopular shared clinical decision-making policy for RSV vaccines in adults age 60 and older should be replaced by risk-based criteria in people age 60-74 and a universal age-based recommendation at 75 and older, the CDC’s Advisory Committee on Immunization Practices agrees.

In what could amount to a de facto enforcement mechanism, the new draft guidance also “strongly encourages” sponsors to share details about their diversity action plan and enrollment goals with the public.

New draft guidance on clinical trial diversity action plans pushes for disproportionately high enrollment of traditionally underrepresented groups, while also asking companies to tailor global programs to US populations and consider diversity aspects that Congress did not outline.