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The FDA has updated its technical guide for sponsors of NDAs or BLAs on submitting clinical trial datasets to CDER’s bioresearch monitoring (BIMO) program. Read More
Semaglutide treatment of overweight or obese individuals does not increase the risk of developing depression or suicidal thoughts or actions, a team of researchers in the US, UK and Denmark reported. Read More
This edition of Quick Notes provides approval notes on Janssen’s and AstraZeneca’s treatments for non-small cell lung cancer, FDA’s clinical hold on BioNTech’s HER3 anti-drug conjugate and “tentative” approval of Yutrepia. Read More
A host of issues found during a recent inspection of Indian API manufacturer Global Calcium, including falsified and duplicated records, have led the FDA to issue a Form 483. Read More
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. Read More
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. Read More
This edition of Quick Notes provides approval notes on treatments for hypoparathyroidism, prurigo nodularis, primary biliary cholangitis and graft-versus-host disease. Read More
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. Read More
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. Read More
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 Lynparza for treatment of endometrial cancer. Read More
This excerpt is from the management report titled “Using Real-World Evidence in Drug and Device Submissions,” based on a webinar from FDAnews, A WCG Company. The presenters were Kristin Zielinski Duggan and Sally Gu of the Washington, D.C., law firm Hogan Lovells. Read More