FDA Policy/General
An FDA drug safety notice says the agency is aware that some patients and healthcare providers may look to unapproved versions of glucagon-like peptide-1 (GLP-1) receptor agonists as an option for weight loss. “This can be risky for patients,” the notice says, “as unapproved versions do not
Devices
FDA has cleared a Moon Surgical 510(k) for its ScoPilot, an artificial intelligence-powered feature on the company’s Maestro System that is intended to ensure a stable and ideal view during laparoscopic surgery. “On-demand and easy to use, ScoPilot allows the laparoscope attached to a Maestro System
Drugs
FDA has granted Johnson & Johnson a fast track designation for its investigational therapy, nipocalimab and its use for treating adult patients with moderate-to-severe Sjögren’s disease (SjD). This follows the agency’s breakthrough therapy designation late last year for the therapy. Sjögren’s disease is a chronic
Devices
Medtronic Neurovascular is recalling its Compatible Pipeline Vantage Embolization (027) Devices and updating the use instructions for their 021 version due to reports about the flexible, braided tube part of the device failing to properly attach or stay attached to blood vessel walls (incomplete wall apposition or braid deformation) during
FDA Policy/General
FDA is rehiring over 1,000 probationary employees that were fired last month after a Maryland federal judge ordered HHS and other federal agencies to reinstate them because proper notice was not provided as required by law. While the Trump administration appeals this and another similar decision by a federal
Drugs
Incyte says it will seek FDA approval for its oral small-molecule JAK1 inhibitor povorcitinib and its use in adult patients with moderate to severe hidradenitis suppurativa, a chronic inflammatory skin condition characterized by painful nodules and abscesses that can cause tissue destruction and scarring. The company says the submission
Devices
Three former executives of Magellan Diagnostics have pleaded guilty to federal charges after concealing a medical device malfunction that led to inaccurately low lead test results for thousands of children and other patients. Former CEO Amy Winslow, former chief operating officer Hossein Maleknia, and former quality assurance and regulatory affairs
Biologics
Orca Bio says its pivotal Phase 3 Precision-T study of Orca-T, an investigational allogeneic T-cell immunotherapy, in certain leukemia patients met its primary endpoint of a statistically significant improvement in survival free of moderate-to-severe chronic graft versus host disease (cGvHD). “At one year, the rate
Drugs
FDA has lifted a clinical hold against vTv Therapeutics’ cadisegliatin clinical program (CATT1 Phase 3 trial) evaluating the first-in-class oral adjunctive therapy to insulin for treating Type 1 diabetes. Cadisegliatin is described by the company as a liver-selective glucokinase activator that has been well tolerated in over
Drugs
AstraZeneca says recent data from the CALYPSO Phase 3 hypoparathyroidism trial showed that eneboparatide, an investigational parathyroid hormone (PTH) receptor 1 agonist, met its primary endpoint with “statistical significance.” The company says the trial is evaluating the therapy’s use in adults with chronic hypoparathyroidism (HypoPT) at 24 weeks, compared
FDA Policy/General
Several years after remote, work-from-home convenience, thousands of FDA employees returned to work 3/17 only to be met with parking congestion and slow security line clearances. Local News 4 (Washington, DC) visited FDA’s headquarters in White Oak, MD for a closer look and reported that there
Devices
FDA is warning healthcare professionals about supply interruptions involving hemodialysis bloodlines because of recent supplier issues. “The disruption in supply of this device is expected to impact patient care and as such may require adjustments to the clinical management of patients receiving acute or chronic hemodialysis,” an agency notice says.
FDA Policy/General
Federal Register notice: FDA is withdrawing approval of a Sage Therapeutics NDA for Zulresso (brexanolone) solution, 100 mg/20 mL after it told the agency that the drug product was no longer marketed and requested the withdrawal. Zulresso is indicated for treating moderate-to-severe postpartum depression. FDA says that
Drugs
Federal Register notice: FDA is withdrawing approval of eight ANDAs from multiple applicants after they told the agency that the drugs were no longer marketed. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA is denying a request for a hearing submitted by Bernardo Garmendia, and is issuing an order permanently debarring him from providing services in any capacity to a person that has an approved or pending drug product application. The actions are based on Garmendia’s 6/2023
Devices
Becton Dickinson’s CareFusion unit has recalled (Class 1) its BD Alaris Systems Manager, including the device’s infusion safety management software, due to software issues that could provide incorrect therapy. The software issue may result in an outdated automated programming request being sent to the device’s progressive care
Drugs
FDA has granted Korro Bio an orphan drug designation for KRRO-110 for treating Alpha-1 Antitrypsin Deficiency (AATD). KRRO-110 is the first RNA editing oligonucleotide product candidate from Korro’s proprietary RNA editing platform, Oligonucleotide Promoted Editing of RNA, according to the company. It is currently being evaluated
Biologics
Despite an HHS decision to cancel (see earlier story) a 3/13-planned Vaccines and Related Biological Products Advisory Committee (VRBPAC) meeting to select the strains and the composition of next season’s influenza vaccines, the agency convened an interagency meeting on the same date to adopt recommendations for vaccine
Devices
FDA has approved a Valcare Medical IDE to assess the safety and functionality of its AMEND Trans-Septal System for treating patients with mitral insufficiency. The company says the device is designed for transcatheter mitral annuloplasty and “features a semi-rigid, closed, D-shaped annuloplasty ring that replicates the current
Drugs
Dr. Reddy’s Laboratories is recalling (Class 1) one lot of levetiracetam in 0.75% sodium chloride injection, 1,000 mg/100 mL single-dose infusion bags because they are incorrectly labeled as levetiracetam in 0.82% sodium chloride injection 500 mg/100 mL single-dose bags. A recall notice
Devices
Smiths Medical has recalled its Portex Endotracheal Tube because some devices have a smaller diameter than expected and may result in inadequate ventilation to patients. According to a recall notice, patients may experience hypoxia, underdose, or cardiopulmonary collapse if an affected device is used. FDA has identified the issue as
FDA Policy/General
Former Justice Department attorney Hilary Perkins, who two days ago was selected to serve as FDA chief counsel, has abruptly resigned her post. FDA released a brief statement on “X” that read: “Hilary K. Perkins has resigned from her position as chief counsel of FDA, effective immediately.” Her ouster was