Some Democratic senators are not fans of FDA’s approval of Biogen/Eisai’s Aduhelm, and are even more critical of the price of the Alzheimer’s therapy. That is providing a new hook to urge action on creating a federal price ‘negotiation’ program – but not any more clarity on a viable path to enacting one.

Patrizia Cavazzoni, FDA Center for Drug Evaluation and Research director, knows she has ‘huge shoes’ to fill. Convincing the CDER staff that she is capable of doing so is job one.

Patrizia Cavazzoni, the new director of the US FDA Center for Drug Evaluation & Research, knows that the has ‘huge shoes’ to fill. Convincing the CDER staff that she is capable of doing so is job one.

COVID has unequivocally shown the advantages of a ‘master protocol’ approach to providing definitive evidence about the benefits (or lack thereof) for repurposed therapies to treat a novel infection. Unfortunately, in the US, the proof has been in the failure of scores of separate studies to generate useful evidence. Can FDA change that before the next pandemic?

A US House hearing focused on long-standing criticism of AbbVie for its ability to delay biosimilar competition for Humira. AbbVie was also able to delay the hearing, and that also seemed to work out well for the company.

Biopharma companies are understandably upset by the Biden Administration’s decision to support a waiver of intellectual property protections on COVID vaccines. But over-reacting may only make matters worse.