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In advance of this week’s adcomm, the FDA has flagged ocular toxicities associated with the antibody-drug conjugate, which received accelerated approval in August 2020 for relapsed or refractory multiple myeloma. GSK ran a confirmatory Phase III DREAMM-3 study to validate Blenrep’s clinical value in this indication, but in November 2022 the ADC failed to significantly improve progression-free survival (PFS) versus pomalidomide plus dexamethasone.
GSK pulled Blenrep from the U.S. market two weeks later, and the FDA’s approval was withdrawn in February 2023.
GSK pulled Blenrep from the U.S. market two weeks later, and the FDA’s approval was withdrawn in February 2023.
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More than thirty years since its 1993 founding, Catherine Owen Adams and Elizabeth Thompson—the R&D combo that has led Acadia since last year—are managing two products on the market and a pipeline estimated to be worth an additional $12 billion in sales.
New data and analyses presented at the American Diabetes Association’s annual meeting highlight the priorities for the next generation of weight loss medicines: muscle preservation, limited side effects and novel targets.
The FDA has several big-ticket decisions lined up to close out July, including applications in lymphoma, rare diseases and a hormone deficiency, while GSK dares to DREAMM again in multiple myeloma.
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Read our takes on the biggest stories happening in the industry.
Vaccine skepticism is at an all-time high in the U.S., and HHS Secretary Robert F. Kennedy Jr. is making some drastic moves in the name of reversing that trend. But misinformation and inconsistencies within the country’s healthcare agencies highlight problems with his approach.
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