Archive for December 2022

A large part of the FDA inspection process is reviewing documents and they need to be accessible promptly on request, an FDA inspections expert advised at the recent WCG FDAnews Annual FDA Inspections Summit in Washington, D.C. Source: Drug Industry Daily

Plaintiffs led by MSP Recovery Claims, a payment recovery firm, have filed a class action lawsuit in federal court alleging Actelion Pharmaceuticals violated the Racketeer Influenced and Corrupt Organizations (RICO) Act by engaging in an illicit scheme to hike the price of blood pressure drugs. Source: Drug Industry Daily

In 2021, manufacturers boosted the cost of seven of the country’s most expensive drugs by more than $805 million without any evidence supporting the price hikes, the Institute for Clinical and Evidence Review (ICER) reports in its latest annual cost analysis. Source: Drug Industry Daily

A federal judge has decided consumer claims that Zantac (ranitidine) causes cancer were not backed by scientific evidence, and thus several big drugmakers can now avoid thousands of U.S. lawsuits. Source: Drug Industry Daily

Companies need to know how to access their archives — day or night — when using a third party for document storage and preparing for an FDA inspection, an FDA inspections expert advised at the WCG FDAnews Annual FDA Inspections Summit in Washington, D.C., Nov. 16-18. Source: Drug Industry Daily

Sponsors of programmed cell death receptor-1 (PD-1) or programmed cell death-ligand 1 (PD-L1) blocking antibodies for cancer can now request approval for intravenous dosing regimens that weren’t included in the pivotal trials or earlier developmental studies, the FDA said in a final guidance released yesterday. Source: Drug Industry Daily

Summit Therapeutics has acquired licensing rights for Akeso’s ivonescimab, an antibody that targets both programmed cell death receptor 1 (PD-1) and vascular endothelial growth factor (VEGF) in patients with nonsmall-cell lung cancer (NCSLC). Source: Drug Industry Daily

A new guideline from the International Council for Harmonization (ICH) promotes the use of a continuous manufacturing (CM) process that can lead to shorter production times, a reduced risk of human error and an increase in quality. Source: Drug Industry Daily

Novartis announced that its radioligand chemotherapy Pluvicto (lutetium Lu 177 vipivotide tetraxetan) extended progression-free survival in men with previously treated prostate-specific membrane antigen (PSMA)-positive metastatic castration-resistant prostate cancer (mCRPC). Source: Drug Industry Daily

Reducing the collection of safety data in late-stage and postapproval clinical trials can improve trial efficiency, the FDA says in a final guidance published on Monday. Source: Drug Industry Daily