Devices
Medical device maker Magellan Diagnostics (Billerica, MA) has pleaded guilty in federal court in Boston to criminal charges arising from its concealment of a device malfunction that produced inaccurately low lead test results for tens of thousands of patients. The company pleaded guilty to two counts of introducing a misbranded
Drugs
Johnson & Johnson says its Carvykti (ciltacabtagene autoleucel) achieved a statistically significant and clinically meaningful improvement in overall survival in multiple myeloma patients in the Phase 3 CARTITUDE-4 study. A company statement says the trial evaluated Carvykti compared to standard therapies to treat patients with relapsed or lenalidomide-refractory
Drugs
Checkpoint Therapeutics says it has completed the resubmission of its BLA to FDA for cosibelimab, an anti-programmed death ligand-1 antibody as a potential new treatment for patients with metastatic or locally advanced cutaneous squamous cell carcinoma who are not candidates for curative surgery or radiation. A company statement
Drugs
FDA has approved Samsung Bioepis’ Pyzchiva (ustelkinumab-ttwe) subcutaneous injection and intravenous infusion as a biosimilar to Janssen’s Stelara (ustelkinumab). Pyzchiva is indicated to treat moderate to severe plaque psoriasis in patients who are candidates for phototherapy or systemic therapy, active psoriatic arthritis, moderately to severely active Crohn’s
Drugs
FDA has approved Genentech’s Vabysmo (faricimab-svoa) prefilled syringe to treat wet age-related macular degeneration, diabetic macular edema, and macular edema following retinal vein occlusion. A company statement says the prefilled 6.0 mg single-dose syringe delivers the same medicine as the 6.0 mg vial that
Drugs
In a 6/20 update to a 2019 guidance, FDA revised the need for switching studies to demonstrate a biosimilar is interchangeable. In an online post, attorney Robert Schwartz (Venable) says the update is based on the agency’s experience gained in approving 13 interchangeable biosimilars since the 2019 guidance
Drugs
A 12/4-12/15/2023 FDA inspection at the Sun Pharmaceutical Industries Limited drug manufacturing facility in Union Territory Dadra and Nagar Haveli and Daman and Diu in India found significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. A 6/18 Warning Letter says the
Biologics
Several law firms have posted analyses of the Supreme Court Loper Bright decision that overturned the 40-year precedent of deference to agency interpretations of ambiguous laws first announced in Chevron. A Sidley Food, Drug, and Medical Device Update says the Supreme Court decision to overturn Chevron deference to agencies
Drugs
FDA says the Web site www.ozempen.com is introducing into interstate commerce misbranded and unapproved new drugs, specifically semaglutide products. A 6/24 Warning Letter says there are “inherent risks to consumers who purchase unapproved new drugs and misbranded drugs. Unapproved new drugs do not carry the same assurances
Drugs
FDA has approved Lilly’s Kisunla (donanemab-azbt) injection to treat Alzheimer’s disease. An agency statement says treatment with Kisunla should be initiated in patients with mild cognitive impairment or mild dementia stage of disease, the population in which the drug was studied in clinical trials. Kisunla is administered
Drugs
Although FDA says that compliance with its new Diversity Action Plan (DAP) initiative outlined in a recent draft guidance won’t take effect until 180 days after the future final guidance is published, drug and medical device sponsors should start planning how they will comply with the significant new requirements.
Drugs
FDA has published a draft International Conference on Harmonization M14 guidance, General Principles on Plan, Design, and Analysis of Pharmacoepidemiological Studies that Utilize Real-World Data for Safety Assessment of Medicines, to recommend international standards for, and promote harmonization of, the general principles on planning, designing, and analyzing observational pharmacoepidemiological
Devices
FDA says CDRH will continue to expand its Total Product Life Cycle Advisory Program (TAP) to include medical devices reviewed in the Office of Radiological Health and the Division of Ophthalmic Devices in the fall of 2024 and the Office of Orthopedic Devices in 2025. A TAP pilot was launched
Drugs
FDA has published a draft guidance, Addressing Misinformation About Medical Devices and Prescription Drugs: Questions and Answers, to respond to common questions firms may have when voluntarily addressing misinformation about or related to their approved or cleared medical products. The document describes existing avenues for communications by firms and also
Drugs
FDA has released a draft guidance entitled “Purpose and Content of Use-Related Risk Analyses for Drugs, Biological Products, and Combination Products.” The document provides information on the purpose and content of a use-related risk analysis (URRA) and how this, along with other information, can be used to determine
Drugs
FDA has published a draft guidance, Essential Drug Delivery Outputs for Devices Intended to Deliver Drugs and Biological Products, describing the agency’s recommendations related to the device design outputs that are essential for establishing and assessing drug delivery performance in medical devices and combination products. The document includes recommendations
Devices
Philips Respironics has issued updated instructions for three of its BiPAP ventilators due to interruptions and/or loss of therapy. An FDA notice says the recall does not involve removing the devices from where they are used or sold. It is considered a Class 1 recall, the notice says, because
Drugs
Public Citizen’s Coalition for Sensible Safeguards says the Supreme Court's 6/28 decision that overturned a 40-year-old legal precedent to gut the so-called “Chevron deference” will harm the public. “The court today, once again, sided with big corporations trying to weaken agencies’ ability to
Devices
Abbott Medical is recalling (Class 1) its HeartMate System Monitor due to “atypical behavior of the System Monitor screen.” The agency notes that the recall is considered a device correction and is not a market withdrawal. The screen issues include screen freezing, overlapping buttons or screens, unresponsive buttons, distorted text
Drugs
FDA has released the form FDA-483 issued following a 4/22-5/10 inspection at the Brookfield Medical/Surgical Supplies outsourcing facility in Brookfield, CT. The four inspection observations in the form were: * failure to follow procedures designed to prevent microbiological contamination of drug products purporting to be sterile
Biologics
FDA has issued Rocket Pharmaceuticals a complete response letter on its BLA for Kresladi (marnetegragene autotemcel; marne-cel), a lentiviral vector-based gene therapy for treating severe leukocyte adhesion deficiency-I (LAD-I). According to the company, the agency letter requested “limited additional” chemistry manufacturing and controls (CMC) information to
Drugs
FDA has approved a Shorla Oncology NDA for Tepylute (thiotepa), a ready-to-dilute formulation for treating breast and ovarian cancer. “This approval fulfills an unmet need by addressing the shortcomings and handling complexities of the current lyophilized powder formulation,” the company says. “We have taken a vital oncology drug