Sometimes a small change of wording has a big effect on the implications of a U.S. FDA guidance, a notion that may apply to the U.S. FDA’s final guidance for the use of computational modeling in device premarket submissions.
The U.S. FDA’s Jan. 5 approval of Florida’s plan to import prescription drugs from Canada to take advantage of their lower price triggered ongoing communication between senior U.S. officials and Canada’s Ministry of Health over Canadian concerns about maintaining sufficient drug supplies.
U.S. physicians who provide radiation services for cancer patients have a long-running feud with the Centers for Medicare & Medicaid Services over a series of payment rate cuts for their services, but these medical societies are now teaming up to address the issue. These medical societies are making the case that payment reform is not only critical for the future of radiation oncology but are also optimistic that congressional interest in the dilemma has quickened sufficiently to suggest that a congressional response may be on tap in 2024.
The U.S. Centers for Medicare & Medicaid Services (CMS) issued the final rule for data interoperability and prior authorization (PA) for health plans, which is designed in part to improve the PA process used by payers.
Dermasensor Inc. received U.S. FDA clearance for its non-invasive skin cancer evaluation device that provides quantitative identification of all skin cancer types at the point of care and within seconds. The point-and-click device is designed to facilitate detection of skin cancers by primary care physicians (PCPs) and speed the time to diagnosis and treatment.
Presage Biosciences Inc. has announced that the FDA has issued a study may proceed notification for testing a pre-GMP drug candidate with the company’s Comparative In Vivo Oncology (CIVO) platform. Owned by Pure Biologics, the drug candidate, PBA-0405, is a ROR1-targeting compound that has been engineered to induce tumor cell killing by cytotoxic immune cells.
Solid Biosciences Inc.’s SGT-003 has been granted orphan drug designation by the FDA. The company’s next-generation Duchenne muscular dystrophy gene therapy candidate was also granted fast track designation last month.
Though the PDUFA date for its BLA wasn’t until March 30, 2024, Vertex Pharmaceuticals Inc. celebrated the U.S. FDA approval Jan. 16 for Casgevy (exagamglogene autotemcel), expanding use the CRISPR/Cas9 gene-edited cell therapy in patients, 12 and older, with transfusion-dependent beta-thalassemia.
The EMA has once again come in behind the U.S. FDA, granting market access to 77 new products in 2023, fewer than half the 157 approvals the FDA processed in the 11 months from January through December 2023.
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