Hopes are that the impact of the US FDA’s investigation into a small number of T-cell malignancies associated with CAR-T therapies will be small since the benefit/risk profile still looks sound.

Money may have become too tight to mention for many biotechs and the IPO window in Europe is not just shut but boarded up. However, big pharma’s need to replenish the pipeline has become urgent and the major players are looking to tap into the continent’s early-stage companies which are driving innovation and provide them with much-needed cash.

Restructuring Edition: OrbiMed/Foresite and Concentra responded quickly after Theseus implemented a 72% workforce reduction and began a search for strategic alternatives despite having $225.4m in cash. REGENXBIO, Novavax and Lyell also revealed job cuts despite large cash stockpiles.

The National Academy of Medicine is launching a Congressionally mandated study of the US FDA’s regulatory approach to rare disease treatments. The first question is whether there is anything more that FDA can do.