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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. Read More
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. Read More
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. Read More
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. Read More
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). Read More
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. Read More