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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 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.

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 factors prosecutors should consider when deciding whether to pursue criminal charges, negotiate plea agreements or enter into other corporate resolutions.

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.

FDA has posted a final guidance entitled “Questions and Answers on Biosimilar Development and the BPCI Act.” The document provides answers to common questions from prospective applicants and other interested parties regarding section 351(k) of the Public Health Service Act, which was added by the Biologics Price Competition and

U.S. representative Josh Gottheimer (D-NJ) and thirty-eight of his colleagues sent a bipartisan letter to HHS and FDA urging them to establish clear, consistent standards for defining rare disease patient populations. The lawmaker is the founder and co-chair of the Congressional Sarcoidosis Caucus. “When 95% of rare diseases do not have cures, we cannot risk discouraging innovation in areas where scientific progress is rapidly outpacing regulatory adaptation,” the letter says.

Biologics — 1 min read FDA has posted a final guidance entitled “Questions and Answers on Biosimilar Development and the BPCI Act.” The document provides answers to common questions from prospective applicants and other interested parties regarding section 351(k) of the Public Health Service Act, which was added by the Biologics Price Competition and Innovation Act of 2009.

Drugs — 1 min read FDA has released a final guidance entitled “Study Data Technical Conformance Guide - Technical Specifications Document” that provides specifications, recommendations, and general considerations on how to submit standardized study data using FDA-supported data standards located in the FDA Data Standards Catalog.

Three stakeholders have submitted general and specific comments to FDA on the agency’s draft guidance on considerations for container closure and device constituent parts for biosimilar and interchangeable biosimilar products.

Biologics — 1 min read MimiVax says it plans to seek a meeting with FDA to review positive results from its Phase 2b SURVIVE trial of SurVaxM, a novel cancer vaccine for patients with newly diagnosed glioblastoma. In a statement, company officials say they want to use the meeting to review the SURVIVE data and align on a path forward.