Drugs

FDA Complete Response for Eagle Anticoagulant

FDA has issued Eagle Pharmaceuticals a complete response letter on a 505(b)(2) NDA for Kangio (bivalirudin injection), a ready-to-use intravenous formulation for use as an anticoagulant. The agency letter requested further characterization of bivalirudin-related substances in the drug product. Eagle will work directly with the FDA to determine an appropriate path forward to address the comments, according to the company. The submission is seeking an indication for use in patients: (1) undergoing percutaneous coronary intervention (PCI) with use of a glycoprotein IIb/IIIa inhibitor, (2) undergoing PCI with, or at risk of, heparin-induced thrombocytopenia and thrombosis syndrome, and (3) with unstable angina undergoing percutaneous transluminal coronary angioplasty. Bivalirudin is the active ingredient in The Medicines Company’s Angiomax.

Rasonque OK’d Across KRAS Mutations Despite Clinical Response Differences

FDA granted approval to Revolution Medicines' Rasonque (daraxonrasib) for metastatic pancreatic cancer despite substantial differences in treatment responses among patients with different KRAS mutations and limited evidence of effectiveness in patients without RAS mutations, according to a newly released approval document. The 321-page review shows that FDA considered

FDA Safety Concerns Complicate Plan to Expand Peptide Compounding

The Trump Administration is developing a temporary policy that would allow compounding pharmacies to dispense certain unapproved peptides despite earlier FDA scientific assessments finding insufficient evidence of their safety and effectiveness, setting up a potential conflict between administration policy and the agency's scientific reviewers. Federal officials are considering

DoJ Enforcement Directive Signals More Scrutiny of FDA-Regulated Firms

A new Department of Justice directive identifying violations of the Federal Food, Drug, and Cosmetic Act (FDCA) among potential targets for fraud enforcement could expose FDA-regulated firms to increased federal investigations and criminal prosecutions, according to an analysis by attorneys at Holland & Knight. The 10/1 directive outlines

Guide on Biosimilar Postapproval Manufacturing Changes

FDA has released a final guidance entitled “Postapproval Manufacturing Changes to Biosimilar and Interchangeable Biosimilar Products — Questions and Answers.” The document explains how manufacturers should document and report changes to approved biosimilars, including changes involving manufacturing processes, production facilities, dosage forms and strengths. Regarding information required for postapproval manufacturing changes,

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Rasonque OK’d Across KRAS Mutations Despite Clinical Response Differences

FDA Safety Concerns Complicate Plan to Expand Peptide Compounding

DoJ Enforcement Directive Signals More Scrutiny of FDA-Regulated Firms

Guide on Biosimilar Postapproval Manufacturing Changes