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Recognizing that a lack of standard methods is the primary challenge to widespread manufacturing of cell and gene therapies, two groups are aiming to lower the barrier by bringing best practices to this branch of the life sciences industry. Read More
Massachusetts-based Editas Medicine announced that the FDA has removed a partial clinical hold on its trial of EDIT-301 (AsCas12a), its experimental gene treatment for severe sickle cell disease. Read More
Bristol Myers Squibb’s (BMS) combination treatment for renal cell cancer missed its primary endpoint of disease-free survival in the phase 3 CheckMate-914 trial, Part A, the company reported. Read More
This two-part series hones in on the specifics of the House and Senate user fee bills, their differences and what the final law, the Food and Drug Administration Safety and Landmark Advancements (FDASLA), may look like when it gets to President Biden’s desk.Read More
The approval provides another treatment option for pediatric patients, who were previously given non-selective immunosuppressants and corticosteroids, the company said. Read More
The FDA issued a warning letter to Jost Chemical Co. — an active pharmaceutical ingredient (API) manufacturer based in Saint Louis, Mo. — for what the agency said was an inadequate investigation into a quality-related complaint and out-of-specification results. Read More