US

Pink Sheet reporters and editors discuss increasing complete response letters for breakthrough designees, FDA changing course on statin use during pregnancy, and efforts to use pandemic innovations to improve clinical research going forward.

A US FDA Advisory Committee’s overwhelming rejection of FibroGen/AstraZeneca’s oral anti-anemia agent is a big setback for the sponsor. But the committee’s reaction to novel strategies used to try to save the application has an important message for all drug developers about the limits of those approaches.

Benefits of the one-shot vaccine outweigh risk, ACIP members agree. One member says he supports its availability but would personally recommend mRNA vaccines instead.

US FDA’s first decision on biosimilars interchangeability might have less meaning for two insulin products, but payer and prescriber responses to interchangeable biosimilars for adalimumab, which are further out on the horizon, may be more instructive regarding the importance of interchangeability status.

Association for Accessible Medicines makes a case for lowering prices in Part D through benefit design reforms enabling quicker and better access to first generics.

NY AG has ‘no comment’ on whether criminal charges will be pursued against company executives; NC AG predicts ‘north of 40 states’ expected to accept settlement and would then need to convince municipalities to come on board. States with ongoing litigation against manufacturers may opt for jury trial instead. 

More than half of the complete response letters issued for applications holding breakthrough status have been issued since 2020, reflecting difficult – and often rancorous – efficacy debates.

As Democrats in the US Congress work to move legislation empowering the Health and Human Services Department to negotiate drug prices directly with manufacturers, the Center For American Progress releases an analysis on which drugs would be targeted by House bill HR 3 and how much prices could be reduced.

In journal article, leaders from academia, industry, NCI and FDA propose building upon pandemic-necessitated flexibilities in clinical research, including making it easier for trial participants to access investigational drugs in their own communities and reduced reporting of uninformative adverse events.

While not an outright rejection, the Deficiencies Preclude Discussion letter came as a surprise given the expectation of the drug’s approval for hyperphosphatemia in adults with chronic kidney disease on dialysis.

Woodcock again defends the decision, saying Congress intended accelerated approval for those situations.

Acting FDA Commissioner Janet Woodcock says stability studies are ongoing and that states shouldn’t get rid of expiring inventory yet.