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Members of the House Committee on Oversight and Accountability grilled the leaders of the nation’s three largest pharmacy benefit managers (PBM) — CVS Caremark, Express Scripts and Optum Rx — in a hearing Tuesday over alleged anticompetitive practices and their companies’ role in increasing prescription drug costs. Read More
The FDA has finalized its guidance on the use of electronic health records (EHR) or medical claims data in clinical studies to support a regulatory decision for effectiveness or safety. Read More
In its efforts to develop new guidances, the FDA is seeking information and comments on evaluating and mitigating the immunogenicity risk of host cell proteins (HCP) and the best way to advance development of new biosimilar biological products. Read More
Merck announced that its investigational monoclonal antibody designed to protect infants from respiratory syncytial virus (RSV) disease met its primary safety and efficacy endpoints. Read More
Prescription benefit managers (PBM) use drug rebate payments to promote use of brand name drugs instead of generics, says a report released ahead of a House Committee on Oversight and Accountability hearing on PBMs. Read More
The FDA offers recommendations on what’s needed to support chemistry, manufacturing and controls (CMC) changes for biosimilars and interchangeable biosimilar products, in a new draft guidance. Read More
This edition of Quick Notes focuses on FDA approval for Roche’s Vabysmo, reintroduction of Susvimo following a recall, EC approval of Dupixent and Samsung Bioepis’ Soliris biosimilar. Read More
The FDA significantly increased foreign inspections in fiscal 2023 while domestic inspections remained flat, according to the agency’s latest annual inspection report. Read More
The Department of Justice’s complaint against Regeneron that the company’s single cash-or-credit price is a violation of the False Claims Act “is not only incompatible with the text of the relevant statute and regulations, but divorced from reality,” the company says in a recent filing. Read More
As the second session of the 118th Congress begins, FDAnews will track important pending legislation, that has been acted on since Dec. 31, 2023 to keep you updated on laws and regulations that could impact your business. Read More
The FDA has issued a final guidance with recommendations on clinical pharmacology considerations for conducting human radiolabeled mass balance studies, including deciding whether and when to conduct the study, designing the study, and reporting results. Read More
Following a Form 483 inspection report that Jiangsu Hengrui Pharmaceuticals of China was found to be storing sterile injectable drugs bound for the US market on corroded metal racks which themselves stood in pools of water dripping from black mold-covered condensation pipes, the company has now received an FDA Warning Letter. Read More