Emerging Company Profile: The US biotech’s Trillium platform, which has caught the eye of Bayer, could enhance radioligand pharmacokinetics and bioavailability while reducing side effects, enabling the development of both therapeutics and imaging compounds.

Even before a new law granted FDA authority to require studies be underway before accelerated approval, review divisions have, in some cases, given sponsors years of advance notice on expectations around study timing, according to a Pink Sheet review of NME accelerated approvals.

But company says the 9 March advisory committee meeting ‘currently does not have any impact’ on Polivy’s existing accelerated approval indication in the third-line setting; agency may be seeking input on the robustness of the progression-free survival benefit and uncertainties about overall survival data in the POLARIX Phase III trial in previously untreated DLBCL.

Scrip takes a look at the increasingly competitive landscape of Korean antibody-drug conjugate developers, which are now vying to catch up with their global rivals in the hot area.