Lumakras is the next test of FDA’s hardening stance
After Exkivity signals another accelerated approval slowdown the Amgen drug tomorrow faces an adcom over its own conditional approval.
ESMO 2023 preview – J&J pulls a Mariposa rabbit out of the hat
And there won’t be a long to wait for the full data, with revelation that Mariposa features among numerous practice-changing late-breakers at ESMO.
ESMO 2023 preview – Pluvicto splashes down among the late-breakers
Beyond lung cancer this year’s ESMO promises several other late-breaking datasets that could change clinical practice.
Approval milestones – Hutchmed, SpringWorks, Crispr and Ionis eye firsts
A work-stretched US FDA has several key approval application still to review by the end of 2023.
Novartis goes 0 for 2 in PD-1 blockade
BeiGene regains rights to tislelizumab as another oncology asset blows up for Novartis.
Bristol seeks novelty in TIGIT
Disclosure of BMS-986442’s second target antigen endorses Agenus, and is highly relevant for GSK and Compugen too.
AbbVie opt-out puts the focus on TeneoOne
The big pharma group had two anti-BCMA assets to choose from, and yesterday gave Harpoon the bad news.
