Drugs
FDA has granted Genentech accelerated approval for an expanded use for Rozlytrek (entrectinib) in treating pediatric patients older than one month with solid tumors that have a neurotrophic tyrosine receptor kinase (NTRK) gene fusion without a known acquired resistance mutation, are metastatic or where surgical resection is likely to result
Devices
Fresenius Medical Care is recalling (Class 1) some of its 2008 series hemodialysis machines because patients may be exposed to non-dioxin-like (NDL) polychlorinated biphenyl acids (PCBAs) that leach from some peroxide-cured silicone tubing used in the machines. “Data provided by the manufacturer indicates that the amount of
Drugs
FDA has approved a new indication for Servier Pharmaceuticals’ Tibsovo (ivosidenib) to treat adults with relapsed or refractory (R/R) myelodysplastic syndromes (MDS) with an isocitrate dehydrogenase-1 (IDH-1) mutation as detected by an FDA-approved test. An agency statement says this is the first targeted therapy approved for
Drugs
FDA has released a revised https://www.fda.gov/regulatory-information/search-fda-guidance-documents/communications-firms-health-care-providers-regarding-scientific-information-unapproved-uses entitled “Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical Products — Questions and Answers.” The documents is
FDA Policy/General
Federal Register notice: FDA is announcing the rates and payment procedures for fiscal year 2024 generic new animal drug program user fees. They are: * Abbreviated Application Fee: $126,582 * Abbreviated Application Fee (512(d)(4) criteria exception: $63,291 * Investigational Drug File Fee: $50,000 * Generic New Animal Drug Product
FDA Policy/General
Federal Register notice: FDA is announcing the (XXX DELETE XXX)rates and payment procedures for fiscal year 2024 animal drug user fees. They are: * Animal Drug Application: $683,673 * Supplemental Animal Drug Application: $341,837 * Animal Drug Product Fee: $12,459 * Animal Drug Establishment Fee: $174,200 * Animal Drug Sponsor
Biologics
FDA has approved a Celltrion BLA for Zymfentra (infliximab-dyyb) for maintenance therapy in adults with moderately to severely active ulcerative colitis (UC) and Crohn’s disease (CD) following treatment with an infliximab product administered intravenously. Zymfentra is a subcutaneous version of Celltrion’s infliximab (Janssen’s Remicade) biosimilar, which
Drugs
FDA has issued Panacea Biotec Pharma a nine-item Form FDA-483 after inspecting the firm’s Himachal Pradesh, India manufacturing 10/3-12 and documenting GMP deficiencies. The company says that the inspection’s findings are “related to improvements in existing procedures and are addressable.” According to the FDA-
Biologics
ImmunityBio has resubmitted its BLA for Anktiva (N-803) in combination with Bacillus Calmette-Guérin (BCG) for treating patients with BCG-unresponsive non-muscle invasive bladder cancer with carcinoma in situ (CIS) with or without Ta or T1 disease. The original BLA was issued a complete response letter in May
Biologics
FDA has issued Sanofi and Regeneron a complete response letter on their supplemental BLA for Dupixent (dupilumab) and its use in chronic spontaneous urticaria, described by the companies as an inflammatory skin condition, which causes sudden, debilitating hives and swelling on the skin. The letter indicates that “additional efficacy data
Devices
FDA has reposted a Medtronic notice warning healthcare professionals about stolen defective McGrath MAC video laryngoscopes that have been offered for sale illegally by unauthorized third parties through various social media platforms. The affected products “did not pass Medtronic’s rigorous quality tests” and were designated for destruction, the notice
Drugs
Merck says its Keytruda (pembrolizumab) plus concurrent chemoradiotherapy reduced the risk of disease progression or death by 30% compared to concurrent chemoradiotherapy alone in treating newly diagnosed patients with high-risk locally advanced cervical cancer. The data come from the Phase 3 KEYNOTE A-18 trial, which is supporting a
FDA Policy/General
Federal Register notice: FDA makes available a final guidance entitled “Benefit-Risk Assessment for Human Drug and Biological Products.” The document is intended to provide drug sponsors and other stakeholders with better clarity on how considerations about a drug’s benefits, risks, and risk management options factor into FDA’s
Devices
FDA has approved a Shockwave Medical PMA for what the company calls an “enhanced” Shockwave C2+ Coronary Intravascular Lithotripsy (IVL) catheter, indicated for lithotripsy-enabled, low-pressure balloon dilatation of severely calcified, stenotic de novo coronary arteries prior to stenting. Shockwave says the device provides 50% more pulses per catheter
FDA Policy/General
Federal Register notice: FDA is making available a final guidance entitled “Voluntary Consensus Standards Recognition Program for Regenerative Medicine Therapies; Guidance for Industry.” The document describes a CBER standards recognition program for regenerative medicine therapies designed to identify voluntary consensus standards that might be used in preparing and reviewing submissions
Drugs
FDA has approved Pfizer’s Penbraya (meningococcal groups A, B, C, W and Y vaccine), a pentavalent vaccine that protects against the most common serogroups causing meningococcal disease in adolescents and young adults aged 10 through 25 years of age. The company says the vaccine “combines the components from two
Devices
Philips Respironics is recalling (Class 1) its V60 Ventilators and V60 Plus Ventilators because the devices contain power management printed circuit board assemblies that do not meet ventilator standards. “The use of the affected ventilators may cause serious adverse health consequences, including power failure, loss of ventilator function, and death,
Devices
A Chinese citizen was arrested 10/19 on a criminal complaint about manufacturing and distributing misbranded medical devices in violation of the Food, Drug, and Cosmetic Act and making false statements to FDA. A government release says Jia Bei Zhu (formerly of Clovis, CA), changed his name, the names of
Drugs
FDA has approved a BioMarin Pharmaceutical supplemental NDA for Voxzogo (vosoritide) to increase linear growth in pediatric patients with achondroplasia with open epiphyses (growth plates). The company says the indication was approved under accelerated approval based on an improvement in annualized growth velocity. Previously, the drug was indicated for children
Drugs
FDA says the Oncology Center of Excellence (OCE) Scientific Collaborative supports agency oncology staff who participate in regulatory science research. OCE says its research looks at applied research questions to address specific challenges arising during the IND and NDA/BLA review process. OCE has identified these nine scientific interest areas
Devices
FDA has cleared a Cardio Flow510(k) for the company’s FreedomFlow Orbital Atherectomy Peripheral Platform. The device is designed with a “modern mechanism of action” to clear plaque blockages in leg arteries, according to the company. “This proprietary, catheter-based design leverages the physics of angular momentum, creating a
FDA Policy/General
Federal Register notice: FDA is making available a final guidance entitled “Enforcement Policy for Non-Invasive Remote Monitoring Devices Used to Support Patient Monitoring.” The enforcement policy applies to modified devices where the original device was a legally marketed, non-invasive remote monitoring device listed in the guidance that measures