Devices
FDA has approved an llumina PMA for its in vitro diagnostic TruSight Oncology Comprehensive test for two companion diagnostic indications. This single test “interrogates” over 500 genes to profile a patient’s solid tumor, “helping to increase the likelihood of identifying an immuno-oncology biomarker or clinically actionable biomarkers that
Drugs
FDA approved 8/23 changes, including a limitation on authorized use, to the terms of the emergency use authorization for Invivyd’s Pemgarda (pemivibart) injection indicated for pre-exposure prophylaxis of Covid-19. An agency memo lists these changes and the rationale for them: * include Pemgarda pseudotyped virus-like particle
Drugs
FDA has several ongoing initiatives related to real-world data and real-world evidence in what has become a dynamic space. That’s the word from FDA chief medical officer Hilary Marston, speaking on a recent “Q&A with FDA” podcast. “We’ve expanded our use of real-world
Drugs
FDA has granted Ractigen Therapeutics an orphan drug designation for RAG-18, a saRNA product candidate for treating Duchenne Muscular Dystrophy (DMD). The therapy is designed to specifically target and activate UTRN gene expression in muscle cells via the RNAa mechanism, according to the company. “The utrophin protein encoded by
Drugs
FDA has approved Amgen’s Blincyto (blinatumomab) for treating adult and pediatric patients one month or older with CD19-positive Philadelphia chromosome-negative B-cell precursor acute lymphoblastic leukemia (B-ALL) in the consolidation phase, regardless of measurable residual disease (MRD) status. Approval is based on data from the Phase
Devices
A group of researchers led by Duke Heart Center’s Sammy Chouffani El Fassi analyzed over 500 recent medical artificial intelligence-driven devices that showed about half of them lacked reported clinical validation data. Their findings were published in Nature Medicine on 8/26. “Although AI device manufacturers boast of
Devices
FDA has escalated its surveillance of iRhythm Technologies based on a second Form FDA-483 issued last month at the company’s Cypress, CA manufacturing facility that was simultaneously inspected with its San Francisco facility, which also ended with an FDA-483 (see earlier story). Presumably, the inspections are related
Drugs
FDA has accepted for priority review a Rhythm Pharmaceuticals supplemental NDA for Imcivree (setmelanotide), a melanocortin-4 receptor agonist for treating obesity due to Bardet-Biedl syndrome or pro-opiomelanocortin (POMC), including proprotein convertase subtilisin/kexin type 1 (PCSK1), or leptin receptor (LEPR) deficiency in children as young as two
FDA Policy/General
Federal Register notice: FDA has determined that Exela Pharma Sciences’ diltiazem HCl in dextrose, 125mg/125mL and 250mg/250mL were not withdrawn from sale for safety or effectiveness reasons. The determination permits the agemcy to approve ANDAs that reference the products if all other legal and regulatory requirements are met.
FDA Policy/General
Federal Register notice: FDA is announcing the withdrawal of two Mammography Quality Standards Act (MQSA) alternative standards due to updated MQSA regulations. The standards being withdrawn are: * MQSA Alternative Standards #11 ‘‘Modifications in the Assessment Categories Used in Medical Reports” * MQSA Alternative Standards #12 “Assessment category for Post Procedure Mammograms
Drugs
FDA has granted BeiGene a fast track designation for BGB-16673 and its use in adult patients with relapsed or refractory (R/R) chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL) who have been previously treated with at least two prior lines of therapy, including a Bruton’s tyrosine
Drugs
FDA has cleared an Insulet 510(k) for the Omnipod 5 Automated Insulin Delivery System (Omnipod 5) for use by those with Type 2 diabetes (ages 18 years and older). Previously, the insulin pump was FDA-cleared for Type 1 diabetes management. The clearance is based on recent data showing
Devices
Public Citizen’s Health Research Group is calling on HHS’ Office of Inspector General to launch an investigation into allegations that retiring CDRH director Jeff Shuren failed to recuse himself from potential conflict-of-interest matters involving medical device firms being represented by his wife’s law firm. An 8/
Drugs
CDER director Patrizia Cavazzoni says agency inspectors and reviewers are seeing deteriorating manufacturing quality in the facilities where biologics and biosimilars are made, and industry needs to address this. Speaking at a Duke Margolis Institute for Health Policy program in Washington, DC 8/20, Cavazzoni noted that BLA and biosimilar
FDA Policy/General
Federal Register notice: FDA is making available a final guidance entitled “Electronic Submission Template for Medical Device De Novo Requests.” The document is intended to to introduce de novo submitters to current resources and associated content developed and made publicly available to support such electronic submissions. To view the notice,
FDA Policy/General
Federal Register notice: FDA is making available additional draft and revised draft product-specific guidances that provide recommendations on, among other things, bioequivalence study designs to support ANDAs. To view the notice, click here.
Drugs
FDA has cleared a SurGenTec 510(k) for its proprietary B-MAN Bone Marrow Aspirate Kit. The device is intended to preserve native cell structure and facilitates the extraction of healthier cells by reducing the manipulation that takes place, according to the company. It uses a centrifuge-free method for
Devices
Inari Medical has begun a Class 1 recall to update the use instructions for its ClotTriever XL catheter after discovering serious adverse events caused when the device becomes entrapped or blocks the lung arteries (pulmonary emboli). A recall notice says affected devices may cause serious adverse health consequences, including device
Devices
FDA has published a guidance, Electronic Submission Template for Medical Device De Novo Requests, to introduce de novo request submitters to the current resources and associated content developed and made publicly available to support de novo electronic submissions to FDA. The document, FDA says, is “intended to represent one of
Devices
FDA has given 510(k) clearance to Procept BioRobotics’ Hydros Robotic System for aquablation therapy. A company statement says Hydros is a next-generation artificial intelligence (AI)-powered platform. Aquablation therapy is used in the treatment of benign prostatic hyperplasia, the company says. It says the Hydros system provides AI-
Drugs
FDA principal deputy commissioner Namandjé Bumpus has issued an order refusing to approve an NDA submitted by Intarcia Therapeutics for ITCA 650 (exenatide in DUROS device). The order says FDA determined that the approval criteria have not been met because Intarcia failed to demonstrate that ITCA 650 is safe for
FDA Policy/General
Federal Register notice: FDA is announcing a 9/26 Oncologic Drugs Advisory Committee meeting to discuss the use of immune checkpoint inhibitors in patients with unresectable or metastatic gastric and gastroesophageal junction adenocarcinoma. The agency intends to seek panel feedback on the following: * adequacy of PD-L1 expression as a