FDA Policy/General
Three SheppardMullin attorneys say a recent CDER Office of Prescription Drug Promotion (OPDP) untitled letter to Novartis alleging that a direct-to-consumer (DTC) TV ad for its breast cancer drug Kisqali (ribociclib) made false or misleading efficacy representations is a good reminder that those working on such ads should
Drugs
FDA says its review of records requested from Nantong Furuida Packaging Products Co., Ltd., in Jiangsu Sheng, China, found significant violations of current good manufacturing practice (CGMP) regulations for finished drugs in the firm’s manufacturing of over-the-counter drugs. A just-released 11/17/2023 Warning Letter says
Drugs
FDA has told Vanda Pharmaceuticals that its ongoing review of a Hetlioz (tasimelteon) supplemental NDA has “identified deficiencies that preclude discussion of labeling and postmarketing requirements/commitments at this time,” according to the company. The submission seeks the drug’s use for treating insomnia characterized by difficulties with sleep initiation.
Drugs
The Duke-Margolis Institute for Health Policy says there are three steps Congress could take to reduce chronic drug shortages. In a 2/5 letter to the House Ways and Means Committee, the institute says many drug shortages are caused by manufacturing quality issues. “Ultimately,” it says, “this poor performance
Drugs
FDA declined an invitation to testify about its foreign inspection program at a 2/6 House Energy and Commerce Oversight and Investigations Subcommittee hearing and received heat from chairman Morgan Griffith (R-VA) over their absence. Other inspection-related hearings will be planned in the future and if FDA rejects
Devices
Percussionaire is recalling its High Frequency Transport Phasitron Breathing Circuit Kits due to a product defect that causes over-pressurization. “There are two parts of the Phasitron kit that must be pressed together during manufacturing,” a recall notice explains. “If one part is angled incorrectly and pressed, the part can
Biologics
Valneva SE, a French specialty vaccine company, says it sold a Priority Review Voucher (PRV) it received from FDA for $103 million. The company says it was awarded the tropical disease PRV in 11/2023 following agency approval of its Ixchiq single-dose, live attenuated vaccine indicated to prevent disease
Devices
FDA has approved an expanded indication for Boston Scientific’s WaveWriter Spinal Cord Stimulator (SCS) for treating chronic low back and leg pain in people without prior back surgery (non-surgical back pain). SCS therapy uses an implanted device that delivers mild electrical impulses to interrupt pain signaling that travel
FDA Policy/General
Federal Register notice: FDA is making available a final guidance entitled “Reporting Amount of Listed Drugs and Biological Products Under Section 510(j)(3) of the Federal Food, Drug, and Cosmetic Act.” The document addresses the process that should be used by registrants of drug establishments to submit reports on
Drugs
A Bloomington, IN, Catalent facility that is being used by Novo Nordisk to expand production of its popular weight-loss drug Wegovy (semaglutide) is not meeting FDA safety and quality requirements. Bloomberg News reports that it obtained an FDA report on its 10/2023 and 11/2023 inspection at the
Drugs
FDA has approved a Veru IND to begin a Phase 2b clinical study to evaluate enobosarm, an oral novel selective androgen receptor modulator (SARM) and its use in preserving muscle mass and physical function and increasing fat loss in patients receiving a Glucagon-like peptide-1 receptor agonist (GLP-1
Drugs
Insight Pharmaceuticals is recalling two lots of its TING 1% Tolnaftate Athlete’s Foot Spray Antifungal Spray Liquid due to elevated benzene levels. The company says that a recent review by a third-party lab found that samples from two lots of the product contained the elevated benzene levels. “While
Drugs
Arizona-based Centera Bioscience (doing business as: Nootropics Depot) and CEO Paul Eftang were sentenced 2/5 in federal court in Concord,NH for distributing unapproved drugs, including tianeptine, into interstate commerce. Centera Bioscience was sentenced to three years of probation, and Eftang to one year of probation. “The defendants
Drugs
Johnson & Johnson is reporting positive data from two studies involving its monoclonal antibody nipocalimab. In the pivotal Phase 3 VIVACITY study, it says nipocalimab met the primary endpoint and achieved a statistically significant reduction in a generalized myasthenia gravis score from baseline over weeks 22 to 24 compared with
Drugs
FDA has released a final guidance entitled “Reporting Amount of Listed Drugs and Biological Products Under Section 510(j)(3) of the FD&C Act.” The document is intended to assist registrants of drug establishments in submitting reports to the agency on the amount of each listed drug manufactured,
Drugs
Ainos has responded to an FDA clinical hold on its low-dose oral interferon (IFN)-alpha formulation, Verona, by seeking to begin a Phase 2 trial of the drug for mild Covid-19 symptoms. If given the green light, the company says the Phase 2 multicenter, parallel, randomized study will
FDA Policy/General
Federal Register notice: FDA is announcing a 3/21 meeting of the Medical Devices Advisory Committee’s Ophthalmic Devices Panel. Committee members are scheduled to discuss a de novo marketing request by Balance Ophthalmics for its FSYX Ocular Pressure Adjusting Pump System, indicated as adjunctive therapy for reducing intraocular pressure
FDA Policy/General
Federal Register notice: FDA is revoking the Emergency Use Authorizations (EUAs) issued to Southern California Permanente Medical Group, for the Kaiser Permanente High Throughput SARS-CoV-2 Assay, and Drexel University College of Medicine, for the SARS-CoV-2 DUCoM-PDL Modified Tetracore Assay. The revocations were requested by the
Devices
In response to an earlier Nurse Assist, LLC product recall, Cardinal Health is recalling products supplied to it for use in Covidien and Cardinal Health brand urology and operating room-specific kits and trays. The products contain 0.9% sodium chloride irrigation USP and sterile water for irrigation USP supplied
Drugs
Vertex Pharmaceuticals plans to file an NDA by mid-year and use a priority review voucher for its cystic fibrosis (CF) combination drug, once-daily vanzacaftor/tezacaftor/deutivacaftor (vanza triple). The decision to submit the NDA comes as the company is reporting Phase 3 data that show the treatment met
Devices
FDA has cleared a Hologic 510(k) for its Genius Digital Diagnostics System with the Genius Cervical AI algorithm, a digital cytology system that the company says combines deep-learning-based artificial intelligence with volumetric imaging technology to help identify pre-cancerous lesions and cervical cancer cells. Traditional screenings for
Devices
FDA has approved Edwards Lifesciences’ Evoque tricuspid valve replacement system for treating tricuspid regurgitation (TR). The device is indicated for the improvement of health status in patients with symptomatic severe TR despite optimal medical therapy (OMT), for whom tricuspid valve replacement is deemed appropriate by a heart team, according to