Speaking of an impending launch of new biosimilars, including pembrolizumab, panelists at a recent event in India asked for regulatory easing from a waiver of Phase III trials for biosimilars to a single body for pre-clinical and trial approvals. The chicken and egg question of VC funding also came up.

The latest meeting of the European Medicines Agency’s human medicines committee, the CHMP, is taking place this week. Decisions are expected for 13 drug marketing applications, there will be a number of oral explanation meetings, and activity is expected relating to a drug at the center of a case involving the European Commission’s rejection of an EMA recommendation.

Public Company Edition: Cullinan and Cidara shifted their strategic directions and found investors to bring along for the ride. Also, Intra-Cellular closed a post-Phase III $575m follow-on offering and Tarsus accessed up to $200m from Pharmakon.

As Merck’s 21-valent vaccine approaches its 17 June user fee goal, the US CDC’s vaccine committee is looking at new adult age-based recommendations and bracing for a full pipeline led by GSK’s 24-valent candidate.