Drug Development
On this episode of the Weekly: Biden administration puts pressure on the biopharma industry; renewed interest in psychedelics after MindMed announces LSD-based candidate meets primary endpoint; bluebird changes its tune.
FEATURED STORIES
Through substantial leadership turnover and workforce cuts, the FDA has continued to support the advanced therapy sector, actively working to remove obstacles to innovation.
With immunology and inflammation blockbusters like AbbVie’s Skyrizi and Rinvoq reeling in nearly $7 billion combined in the third quarter, the pipeline-in-a-product strategy has never been more attractive.
The cholesterol-lowering drug is part of a suite of medicines that also includes MariTide and that Amgen Chief Medical Officer Paul Burton hopes will make the company the “undisputed leader in the management of cardiometabolic risk for patients” by 2030.
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THE LATEST
Galmed announces positive late-stage results in biopsy-proven NASH patients.
In a recently published study, MD Anderson researchers achieved curative responses in pancreatic cancer models by targeting checkpoints in T cells and myeloid suppressor cells.
Geron announced Wednesday positive topline results from the Phase III IMerge trial evaluating the telomerase inhibitor, imetelstat, in lower-risk myelodysplastic syndromes patients.
Vera Therapeutics’ stock crashed following the reveal of data from a Phase IIb study of atacicept in IgAN.
Amgen’s Repatha may cause cardiac harm, according to a reassessment of the biologic’s late-stage trial data.
Gilead and EVOQ Therapeutics announced a partnership to develop immunotherapies for rheumatoid arthritis and lupus.
Chemomab’s experimental antibody shows promise in NASH.
Two documents recently came to light: first, the results of a congressional investigation into the approval of Aduhelm; second, a revised clinical trial consent form for lecanemab.
Eli Lilly and ProQR Therapeutics expand their RNA-editing collaboration.
Mergers and acquisitions are expected to be a key theme in the pharmaceutical industry in 2023.