Drugs
CDER has posted a drug development qualifying tool to support treatments for alcohol use disorder (AUD). The tool is based on a two-level reduction in risk drinking level (RDL) of alcohol consumption and was validated as clinically meaningful, the Center says, adding that it can serve as an acceptable
Biologics
FDA has placed a clinical hold on a Phase 3 study evaluating the efficacy, safety and immunogenicity of Moderna’s trivalent vaccine against norovirus (mRNA-1403) after a case of Guillain-Barré syndrome was reported. It is a two-season vaccine and the Northern Hemisphere portion of the study is
Biologics
FDA has approved Sanofi-Aventis’ Merilog (insulin-aspart-szjj) as a biosimilar to Novo Nordisk’s Novolog (insulin aspart) for improving glycemic control in adults and pediatric patients with diabetes mellitus. An FDA release says Merilog is the first rapid-acting insulin biosimilar product approved by the agency. It is
Devices
Abiomed is recalling (Class 1) Impella RP with SmartAssist and Impella RP Flex with SmartAssist heart pumps to update their use instructions due to a risk that the tip of guidewires or other medical devices may come into contact with the pump during insertion, adjustment, or removal. The inadvertent contact
FDA Policy/General
Two Web pages on draft guidances that FDA was ordered by a federal judge to restore earlier this week (see story) are back online, but they now include a Trump administration statement that disparages and condemns gender ideology. One draft guidance is intended to increase enrollment of females in clinical
Drugs
Bristol Myers Squibb says its Phase 3 RELATIVITY-098 trial evaluating Opdualag (nivolumab and relatlimab-rmbw) for treating patients with completely resected stage III-IV melanoma did not meet its primary endpoint of recurrence-free survival. It notes that the therapy’s safety profile observed in the trial was consistent
Drugs
Responding to an FDA draft guidance on the drug accelerated approval program, the Kaiser Permanente healthcare system says additional reforms are needed. The Kaiser response says accelerated approval shifts more evidence generation and evaluation to later in a product’s lifecycle, after its marketing has already begun. “The result of
Drugs
FDA has approved an Astellas Pharma supplemental NDA for Izervay (avacincaptad pegol intravitreal solution) that revises the labeling for the drug’s use in treating geographic atrophy (GA) secondary to age-related macular degeneration (AMD). The approval cover’s Izervay’s use without a limitation on duration of dosing, according
Drugs
A Buchanan Ingersoll & Rooney 2/6 petition asks FDA to take two specific actions regarding Leukeran (chlorambucil) 2 mg tablets, indicated to treat some leukemias and lymphomas. The petition specifically asks that FDA: * maintain and strictly apply the requirements of the current product-specific guidance for chlorambucil, which represents
Drugs
Endo is petitioning FDA to impose restrictions on 505(b)(2) and 505(j) applications for pharmaceutical equivalents of specific ready-to-use concentrations of intravenous epinephrine covered by an Endo NDA that FDA approved on 4/21/2023. The company’s 2/12 petition specifically asks FDA to: * refrain
FDA Policy/General
The U.S. Senate has confirmed vaccine skeptic Robert F. Kennedy Jr. to serve as HHS secretary. The 52-48 confirmation vote closely mirrored party lines, with only one Republican defection — Mitch McConnell (R-KY), who is retiring at the end of his term next year and has often been
Drugs
A pharmacovigilance study of the second-generation antidepressant trazodone based on reports in the FDA Adverse Event Reporting System (FAERS) between 2004 and 2024 identified several new adverse events. The study, reported in the journal Nature, was conducted by researchers at a Chinese medical school and hospital. The report says
Drugs
A Friends of Cancer Research study update found FDA continues to review and approve novel oncology drugs faster than the European Medicines Association (EMA), oncology drugs are submitted for review earlier at FDA, and drug sponsors use FDA’s expedited programs more frequently than those at the EMA. “These factors,
Biologics
Sanofi and Johnson & Johnson have discontinued the development of their vaccine candidate for extraintestinal pathogenic E. coli because Phase 3 data show that it was not sufficiently effective at preventing invasive E. coli disease (IED) compared to placebo. The decision was based on a review by an independent data
Drugs
The DC District Court has ruled in FDA’s favor regarding a Vanda Pharmaceuticals lawsuit seeking an agency order to revoke the approval of a Teva ANDA for a generic copy of Hetlioz (tasimelteon) for treating non-24-hour sleep-wake disorder in blind patients. Vanda contended that because Teva’
Devices
The Department of Justice has sent a civil investigative demand (CID) to Inspire Medical over allegations of false claims submitted to government healthcare programs for its sleep apnea implant. CEO Tim Herbert reportedly revealed the CID during a 2/10 earnings call but gave few details. The CID reportedly requests
Drugs
FDA says it has not changed its intentions on enforcement discretion for drug compounders as the national GLP-1 (glucagon-like peptide-1) supply begins to stabilize. An agency statement says the timeframes during which it does not intend to take action against compounders for violations of the Federal Food,
Drugs
FDA has approved a Genentech NDA for a new tablet formulation of Evrysdi (risdiplam) for treating people with spinal muscular atrophy (SMA). The 5 mg Evrysdi tablet can either be swallowed whole or dispersed in water, according to the company. “The approval of the Evrysdi tablet was based on the
Drugs
Travere Therapeutics says it plans to submit an sNDA to FDA for traditional approval of a new indication for Filspari (sparsentan) to treat focal segmental glomerulosclerosis. A company statement says the sNDA will be based on data from the Phase 3 DUPLEX and Phase 2 DUET studies. It is to
Drugs
FDA has approved a Pfizer supplemental BLA for Adcetris (brentuximab vedotin) in combination with lenalidomide and rituximab for treating adult patients with relapsed or refractory large B-cell lymphoma (LBCL), including diffuse large B-cell lymphoma (DLBCL), including DLBCL arising from indolent lymphoma, or high-grade B-cell lymphoma, after
Drugs
A 6/26-6/30/2023 FDA Bioresearch Monitoring Program inspection at ISOThrive, Inc., in Healdsburg, CA, found objectionable conditions in its role as sponsor of two trials of an investigational drug. A 2/4 Warning Letter says the specific issue was ISOThrive’s failure to submit an IND application
Drugs
A 9/2-9/6/2024 FDA inspection at the Wuhu Nuowei Chemistry drug manufacturing facility in Xuancheng, China, found significant deviations from current good manufacturing practice (CGMP) regulations for active pharmaceutical ingredients (APIs). A 2/4 Warning Letter says the specific deviations were: * failure to ensure that all specifications