U.S. FDA Commissioner Robert Califf offered the keynote address at this year’s annual meeting of the Food and Drug Law Institute (FDLI), revisiting recent events that have roiled the agency’s staff and reputation. Califf made a point of emphasizing the need for new statutory authorities in connection with the supply chains for FDA-regulated products, and remarked that his return to the agency will not be a reversion to the norm in this context.
New and updated preclinical and clinical data presented by biopharma firms at the Endocrine Society annual conference, including: Astellas, Bridgebio, Eiger, Horizon, Innovent, Neurocrine, Novo, Orphagen, Rhythm, Versanis.
New and updated preclinical and clinical data presented by biopharma firms at the European Hematology Association Congress, including: Abbvie, Affimed, Agios, Ascentage, Canbridge, Crispr, Daiichi, Disc, Genmab, Iaso, Innovent, Mustang, Novartis, Vertex, XNK.
A lot of eyes are on the World Trade Organization (WTO) Ministerial Conference taking place in Geneva June 12-15, as member countries try to reach a consensus on a proposal that would allow certain members to waive intellectual property (IP) rights on COVID-19 vaccines for at least three to five years.
Daiichi Sankyo Co. Ltd.’s quizartinib met the primary endpoint of overall survival in the pivotal phase III Quantum-First study, which tested the addition of quizartinib to chemotherapy vs. chemotherapy alone for adults with newly diagnosed FLT3-ITD-positive acute myeloid leukemia (AML).
At the European Hematology Association’s annual meeting in Vienna last week, companies reported impressive progress for the treatment of sickle cell disease.
New and updated preclinical and clinical data presented by biopharma firms at the European Hematology Association Congress, including: Abbvie, ADC, Apellis, Aruvant, Caribou, Cogent, CTI, Cytovia, GBT, Genentech, GT, Imago, Janssen, Keros, MEI, Morphosys, Oryzon, Roche, Ryvu, Sobi, Vincerx, Vor.
Analysts have already started tagging Cogent Biosciences Inc.’s bezuclastinib as potentially best in class, after the company presented impressive, though early stage, data at the European Hematology Association Congress in Vienna demonstrating promising efficacy and a possibly differentiating safety profile for the selective KIT D816V inhibitor in advanced systemic mastocytosis.
New and updated preclinical and clinical data presented by biopharma firms at the American Society of Clinical Oncology annual meeting, including: Ascentage, CNS, PMV.
Hua Medicine Ltd. presented findings from two phase III trials of its first-in-class dual-acting glucokinase activator dorzagliatin that show the drug significantly improved early phase insulin secretion and glucose sensitivity in patients with type 2 diabetes, thereby restoring glucose homeostasis to treat the underlying cause of diabetes.
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