FDA Policy/General
Two clinical research facility owners have pleaded guilty in the U.S. District Court for the Southern District of Florida to conspiracy to commit wire fraud in connection with their work on two clinical trials testing drugs designed to treat asthma. According to a Justice Department release, Angela Baquero and
Drugs
FDA has sent Warning Letters to six companies responsible for introducing unapproved fat-dissolving injectable drug products into interstate commerce. The letters were sent to Amazon.com, Fox Pharma, Filler Lux USA, Hyaluron Pen Store (Glow Nest Beauty), Julian Naya Beauty, and Vivid Scientific. The companies were told to respond
Drugs
FDA has accepted for review a Sydnexis NDA for SYD-101 (topical low-dose atropine) for treating progression of pediatric myopia. The agency has set a user fee review action date of 10/23. The submission is based on three-year primary and secondary endpoints from the STAR Study, showing
Drugs
CDRH is losing its top science official — chief scientist and deputy Center director Doug Kelly. In a recent Linkedin post announcing his abrupt departure, Kelly said he is departing FDA to write a “new chapter.” He bravely joined FDA in 2020 after taking a break from his 30-year career
Devices
FDA has cleared a Beckman Coulter Diagnostics 510(k) for its DxC 500i Clinical Analyzer. The integrated clinical chemistry and immunoassay analyzer is designed to enhance laboratory efficiency by offering high throughput and processing up to 800 clinical chemistry tests and 100 immunoassay tests per hour, according to the company.
FDA Policy/General
FDA has appointed former business consultant Jim Traficant as chief of staff where he will oversee the day-to-day management and lead the agency’s major initiatives. In this role, “Mr. Traficant provides strategic direction to senior leadership to advance FDA’s priorities and works closely with the leadership
Drugs
Mineralys Therapeutics has announced “positive topline data” from its pivotal Launch-HTN Phase 3 and pivotal Advance-HTN Phase 2 trials assessing lorundrostat’s efficacy and safety for treating uncontrolled or resistant hypertension. “Both trials successfully achieved statistical significance and were clinically meaningful in their pre-specified primary efficacy endpoints
Drugs
FDA is clarifying its policies for compounders of GLP-1 products for weight-loss and treating diabetes following a court ruling in Texas that denied a preliminary injunction sought by the Outsourcing Facilities Association to allow continued compounding of the products. Regarding tirzepatide (Lilly’s Zepbound and Mounjaro), the agency
Devices
Dexcom says it was issued on 3/4 an FDA Warning Letter following inspections at the company’s facilities in San Diego, CA and Mesa, AZ. The letter cited deficiencies contained in response letters sent by Dexcom after receiving Form FDA-483 from the inspections. “The Warning Letter describes observed
FDA Policy/General
As many as 80,000 federal employees at HHS, including FDA, are being offered up to a $25,000 buyout to retire or leave their government employment as part of a new Trump Administration tactic to cut costs. The buyouts have some exclusions, such as FDA inspectors, product reviewers (paid
Drugs
It appears that FDA has belatedly inspected India’s Glenmark Pharmaceuticals after a recent ProPublica investigative report found that the agency hadn’t shifted any attention to the firm’s Madhya Pradesh facility despite several recalls for pills that don’t dissolve properly. The report focused on a 5/2024
Drugs
Fresenius Kabi USA has recalled its Ivenix LVP software, embedded in its Ivenix Infusion System, due to anomalies associated with software versions 5.9.2 and earlier. The anomalies have the potential to cause serious patient harm or death, a recall notice says. For example, if during an alarm mode
FDA Policy/General
FDA has granted Plus Therapeutics an orphan drug designation to Rhenium (186Re) Obisbemeda, a radiotherapy for treating leptomeningeal metastases (LM) in patients with lung cancer. The designation is based on data from the ReSPECT-LM Phase 1 single-dose trial, according to the company. It is now advancing the therapy
Devices
FDA has cleared a Zimmer Biomet 510(k) for its Persona Revision SoluTion Femur, a revision knee implant as an alternative for patients with sensitivities to certain metals (nickel, cobalt, and chromium). The device “leverages a proprietary surface-hardening treatment designed to enhance wear performance, which offers surgeons an array
FDA Policy/General
Federal Register notice: FDA is making available its decision to deny a request for a hearing on a recent CDER refusal to approve a Vanda supplemental NDA for Hetlioz (tasimelteon) capsules for treating insomnia characterized by difficulties with sleep initiation. The refusal was outlined in a 3/2024 complete response
EIRs/483s
Johnson & Johnson is discontinuing the Phase 3 VENTURA development program evaluating aticaprant as an adjunctive treatment for major depressive disorder due to a lack of sufficient efficacy data in the target patient population. “The data confirmed aticaprant is safe and well-tolerated, and no new safety signals were identified,
FDA Policy/General
Most of FDA’s drug inspection-based Warning Letters issued in fiscal year 2024 went to domestic firms, although the percentage of international firms being inspected ticked upward, according to Eliquent Life Sciences’ (formerly consulting firm Greenleaf Health) officials Liz Oestreich, Kalah Auchincloss, and Erin Hartmann. Writing in an online
Biologics
FDA has approved a Celltrion BLA for Omlyclo, the first interchangeable biosimilar to Genentech’s Xolair (omalizumab). The biosimilar is approved for treating the following conditions: * Moderate to severe persistent asthma in patients greater than six years of age whose asthma symptoms are not well controlled with inhaled corticosteroids. * Chronic
Drugs
FDA has denied a Vanda Pharmaceuticals request for a hearing on the agency’s proposed refusal to approve the company’s sNDA for Hetlioz (tasimelteon) to treat insomnia characterized by difficulties with sleep initiation. The FDA 2/26 decision, signed by acting commissioner and principal deputy commissioner Sara Brenner, says
Devices
FDA says the Nuwellis 12/11/2024 recall of certain lots of its AquaFlexFlow UF 500 Plus extracorporeal blood circuits is Class 1. The company said the affected units may indicate “ultrafiltrate weight mismatch” or “excessive weight mismatch” alarms while in use. “If too many weight mismatch alarms occur,” the
Biologics
FDA has approved a Neurotech Pharmaceuticals BLA for Encelto (revakinagene taroretcel-lwey) for treating macular telangiectasia Type 2 (MacTel), a neurodegenerative disease of the retina in adults that causes progressive and irreversible vision loss. The gene therapy uses an “encapsulated cell therapy technology designed to continually deliver therapeutic doses of
Devices
Medtronic’s Micro Therapeutics unit has recalled (Class 1) its Pipeline Vantage Embolization Device with Shield Technology after it determined that the use of the embolization device with diameters greater-than-or-equal-to 4mm may lead to incomplete wall apposition and braid deformation. A recall notice says that these