FDA Inspection Readiness: Be Able to Produce Your Documents Quickly
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…
Actelion Faces RICO Suit for Allegedly Overcharging for Blood Pressure Drugs
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…
Seven Unsupported Drug Price Hikes Cost Consumers $805 Million in 2021, Says ICER
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…
Federal Ruling May Allow Pharma Giants to Escape Thousands of Zantac Lawsuits
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.…
Inspection Readiness: Ensuring Access to Contracted Archives and Documenting Drafts
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…
Sponsors Can Seek Alternative Dosing Regimens for PD-Blocking Antibodies
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…
Summit Gets Licensing Rights for Bispecific Antibody Targeting NSCLC
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…
ICH Signals All Systems Go for Continuous Manufacturing
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…
Novartis’ Pluvicto Racks Up Second Win for PSMA Prostate Cancer
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:…
FDA Adopts ICH E19 Guideline on Selective Safety Data Collection
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
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