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Also, CRO Syneos Health appointed an executive to its newly created DE&I position, while Alterity started a new Phase II study in multiple system atrophy, Antabio dosed the first patients in its Phase I study of an antibiotic for hospital infections, and Structure Therapeutics started a Phase IIa trial of its GLP-1 agonist in obesity and diabetes, with plans for a Phase IIb trial in 2024.
The XinThera deal gives Gilead multiple PARP1 and MK2 inhibitors. Also, Roche licenses a HER2 kinase inhibitor from Zion, Amgen partners with TScan in Crohn’s disease and Baxter sells the last of its biopharma operations – a CDMO business – for $4.5bn.
Panelists at the BIO CEO & Investor meeting talked about ways to improve trial diversity. Also, GSK and Pfizer released retrospective analyses of diversity in their trials, while J&J is working to improve diversity with Stand Up To Cancer.
McKesson’s exit from the space forced sponsors to switch vendors managing their REMS programs, which in some instances affected patient access to drugs. Omnibus legislation requires GAO report and collection of public input on factors FDA should consider in reviewing vendor changes.
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