Archive for August 2024

This week, the FDA published modified a rule and issued final guidance on medical device voluntary malfunction reports. Source: Drug Industry Daily

This edition of Quick Notes features announcements of J&J’s acquisition of V-Wave, Paragonix Technologies’ sale to Getinge, Dupont’s purchase of Donatelle Plastics and Stryker’s deal to buy Vertos Medical. Source: Drug Industry Daily

Following an FDA inspection of its North Carolina facility that found inadequate personnel training, non-implementation of quality control procedures and scuttle fly larva on employee clothing, Shanghai-based CARsgen Therapeutics has been issued a Warning Letter. Source: Drug Industry Daily

House Committee on Oversight and Accountability Chairman James Comer (R-Ky.) has requested that the CEOs of three major pharmacy benefit managers (PBM) correct the record for statements made last month during their appearance before the committee. Source: Drug Industry Daily

This edition of Quick Notes provides approval notes on treatments for hypoparathyroidism, prurigo nodularis, primary biliary cholangitis and graft-versus-host disease. Source: Drug Industry Daily

Sponsors appear more informed and prepared than sites for the upcoming changes to the ICH E6 — Good Clinical Practices guideline, according to a newly published survey by Avoca, a WCG company. Source: Drug Industry Daily

The FDA has finalized guidance on the Voluntary Malfunction Summary Reporting (VMSR) program that allows manufacturers to submit medical device reports (MDRs) for certain low-risk devices to the agency on a quarterly basis instead of sending individual malfunction reports. Source: Drug Industry Daily

The CEO that founded Liveyon, a manufacturer and distributor of stem cell-derived products tied to bacterial infections requiring hospitalization, has plead guilty to felony distribution of unapproved drug products, the Department of Justice (DOJ) announced. Source: Drug Industry Daily

In this edition of Quick Notes EU, we note a new EMA guidance on treating exposure to chemical agents used as weapons, the UK’s decision to offer Vertex’s gene editing therapy Casgevy via the NHS for treating an inherited blood disorder, approval of Regeneron’s Ordspono antibody for treatment of lymphoma, and of AstraZeneca’s Imfinzi and…