With Intarcia's request, the rarely used mechanism could now produce two hearings this year, but outcomes of the few other times the process has been undertaken should not generate a lot of confidence for sponsors that this a path that they want to go down.

EQRx has raised at least $750m since it launched in January 2020 and will have $2bn to fund its ongoing development of low-cost drugs after merging with a special purpose acquisition corporation.

John Leppard with Washington Analysis says the Medicare agency’s recent delay of the MCIT breakthrough devices rule until mid-December suggests the CMS will likely scrap it altogether and start from scratch.

Prices for J&J and Pfizer’s COVID-19 vaccines will be watched closely as India permits private sales. While demand is set to spike with age criteria for those eligible to receive the shots expanded, local manufacturers Serum Institute and Bharat Biotech are ramping up capacities with the government’s help.