Drugs

Elevar, Hengrui Resubmit Liver Cancer Therapy Following 3rd Rejection

Elevar Therapeutics and China's Hengrui Pharmaceuticals have resubmitted a rivoceranib plus camrelizumab as a first-line treatment for patients with unresectable or metastatic hepatocellular carcinoma (HCC).

The companies’ resubmission marks the fourth attempt to win U.S. approval, and follows three previous complete response letters (CRLs) issued in 5/2024, 5/2025 and 7/2026. The most recent rejection cited GMP deficiencies at a manufacturing facility, rather than concerns about the treatment's clinical efficacy or safety, according to the companies.

Media reports indicate that FDA recently classified inspections of the relevant manufacturing facilities as Voluntary Action Indicated, and the companies believe they have addressed the manufacturing deficiencies identified in the latest CRL.

The applications are supported by the global Phase 3 CARES-310 trial, in which the combination achieved a median overall survival of 23.8 months, compared with 15.2 months for sorafenib. The treatment reduced the risk of death by 36%, according to the companies.

Some Advisory Committee Patient Reps Have Conflicts: Study

An analysis by two University of Southern California policy researchers finds that between 2013 and 2022, some 38% of FDA advisory committees included either a patient or consumer representative with active ties to an advocacy organization funded by a drug company. Writing in an open-source article for Project Hope,

Former FDA Official Questions Agency Role in Drug Pricing

Former FDA regulatory counsel and now-partner at Spencer Fane Brian Malkin is questioning whether the agency should become more directly involved in the Trump administration's drug-pricing initiatives, raising concerns about the potential direction of FDA policy under commissioner nominee Heidi Overton, whose nomination remains pending in

FDA Uses Machine Learning to Identify Opioid CV Signals

FDA researchers and academic collaborators identified nearly 80,000 prescription opioid-related cardiovascular adverse event signals in a large-scale analysis of the agency's Adverse Event Reporting System, suggesting that machine learning could improve postmarketing drug safety surveillance. The study, published September 28 in Frontiers in Drug Safety

CGMP Violations Seen in Eurofins Labs Inspection

A 6/1-6/3 FDA inspection at the Eurofins SF Analytical Laboratories drug manufacturing facility in Horsham, PA, found significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. A just-released 10/6 Warning Letter says the three specific violations were: * failure to ensure that laboratory

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Some Advisory Committee Patient Reps Have Conflicts: Study

Former FDA Official Questions Agency Role in Drug Pricing

FDA Uses Machine Learning to Identify Opioid CV Signals

CGMP Violations Seen in Eurofins Labs Inspection