The U.S. FDA’s latest draft guidance for premarket cybersecurity considerations expands considerably on the previous edition, and suggests that the manufacturer’s cybersecurity responsibilities include security in a health care facility’s network.
The use of organoids in preclinical research has reached a tipping point, with U.S. FDA approval of the first drug to enter clinical trials on the basis of efficacy data derived only from these advanced cell models.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Amryt, Beigene, G1, Lantern, Novavax, Revolo, Sinovac, Summit.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Amarin, Avrobio, Immedica, Neoimmunetech, Orthox, Provepharm, Rznomics, SK.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Basilea, Bellus, Byondis, Citius, Cyxone, Dyne, Fresenius, Greenwich, Novartis, Y-mabs.
Legislation that would renew the U.S. FDA’s user fee programs is stuck in process on Capitol Hill, a predicament that seems to resist resolution to date. FDA commissioner Robert Califf said on a July 12 webinar that the FDA “is a decision-making machine” that is reliant on both user fees and congressional appropriations, and that a failure on the part of Congress to act on user fee legislation may force the agency to halt new hires and possibly lay off some FDA staff.
The revised Build Back Better bill Democrats in the U.S. Senate are looking to pass in the next few weeks could deliver savings of $18 billion to $24 billion per year from 2028 through 2031 through drug pricing reforms that include direct Medicare price negotiations, according to a Congressional Budget Office estimate.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Anthos, Arcutis, Can-Fite, Iterum, Lipocine, Perrigo, Pfizer, SCG.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Alimera, Horizon, MGC, Puma, Siga.
Jiangsu Hengrui Pharmaceuticals Co. Ltd. plans to expand its androgen receptor inhibitor, rezvilutamide, to markets abroad after getting a thumbs up from China’s NMPA for treating metastatic hormone-sensitive prostate cancer patients with high-volume disease burden.
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