Drugs
A bipartisan coalition of 37 state Attorneys General (AGs) is urging FDA to take enforcement actions against online sellers of “harmful counterfeit versions of popular weight-loss and diabetes drugs like Ozempic, Wegovy, Mounjaro, and Zepbound.” In a 2/19 letter to the agency, the AGs warn that counterfeit GLP-
Drugs
The Sedgwick “State of the Nation 2025” report shows that medical device recalls increased 8.6% in 2024, from 975 recalls in 2023 to 1,059 in 2024. The report finds that drug recalls dropped 31%, from 571 in 2023 to 356 in 2024. Device failure was the leading recall
Drugs
A 3/20-4/3/2024 FDA inspection at the Jagsonpal Pharmaceuticals drug manufacturing facility in Gurugram, Haryana, India, found significant deviations from current good manufacturing practice (CGMP) regulations for active pharmaceutical ingredients (APIs) and other violations. A 2/5 Warning Letter says specific deviations and violations were: * failure of
Drugs
An 8/12-8/16/2024 FDA inspection at the Tyche Industries drug manufacturing facility in Kakinada, Andhra Pradesh, India, found significant deviations from current good manufacturing practice (CGMP) regulations for active pharmaceutical ingredients (APIs). A 2/6 Warning Letter says specific violations were: * failure to record all quality-related
FDA Policy/General
In a guest Med Device Online column, ERA Sciences executive director Eva Kelly lists and analyzes FDA’s top five citation issues for data quality in 2024. The issues were: * governance and standard operating procedure weaknesses; * validation deficiencies; * system inventory gaps; * missing records or data missing key ALCOA++ (attributable, legible,
Drugs
FDA has approved a Deciphera Pharmaceuticals NDA for Romvimza (vimseltinib), a kinase inhibitor, for adult patients with symptomatic tenosynovial giant cell tumor (TGCT) for which surgical resection will potentially cause worsening functional limitation or severe morbidity. TGCT is a rare, non-malignant tumor that forms within or near joints, according
Drugs
AlgoTx says that based on mixed results from the Phase 2 ACT trial, it sees a path to continue to develop ATX01, its first-in-class therapeutic for chemotherapy-induced peripheral neuropathic pain. A company announcement said the trial “provided encouraging signs of ATX01 efficacy, particularly at the higher concentration
Drugs
FDA has accepted for priority review a Gilead Sciences NDA for lenacapavir, a twice-yearly injectable HIV-1 capsid inhibitor, for use in preventing HIV as pre-exposure prophylaxis. The agency has set a review action target date of 6/19. The submission is based on data from the Phase
Drugs
ICU Medical is recalling one lot of potassium chloride injection bags packaged in cases indicating 20 mEq per bag. The company says it has received a customer complaint which states that the 20 mEq bags have incorrect overwrap labels which state 10 mEq. If a healthcare provider mistakenly calculates the
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
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
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,
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’
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